Derrick Gingery

Two years after the Food and Drug Administration refused to review T-DM1 for accelerated approval, Roche/Genentech Inc. has resubmitted the application with a statistically significant overall survival advantage in hand – FDA’s gold standard for oncology approvals.

The company announced Aug. 27 that it had submitted a biologics license application (BLA) to the FDA for the antibody drug conjugate trastuzumab emtansine, a combination of the monoclonal antibody trastuzumab (Herceptin) with the potent cytotoxic agent DM1, connected by a stable linker based on technology licensed from ImmunoGen Inc.

Genentech expects to submit a marketing authorization application to the European Medicines Agency soon.

[Editor’s note: Genentech has clarified that the updated overall survival analysis was not included in the initial BLA resubmission. It will be provided to FDA during its review of the application.]

The company also announced further results from the EMILIA study, showing T-DM1 had a statistically significant overall survival benefit in HER2-positive metastatic breast cancer, compared with GlaxoSmithKline Inc.’s lapatinib (Tykerb) in combination with capecitabine (Xeloda). Roche did not release actual figures, which will be presented at an upcoming medical meeting.

At the American Society for Clinical Oncology meeting in June, EMILIA authors showed a 3.2-month median progression-free survival benefit. Lead investigator Dr. Kimberly Blackwell, professor of medicine and assistant professor of radiation oncology at Duke Cancer Institute, Duke University, Durham, N.C., also said at the time there was a trend toward an overall survival improvement.

Analysts were not surprised at the news, given the progression-free survival advantage. J.P. Morgan said in an Aug. 27 note that its forecasts already expected a survival benefit in many treatment settings and that while markets reacted favorably to the news, ImmunoGen "already gets credit for this highly promising product."

Priority Review Expected

The positive data also should allow for a quick FDA approval. Priority review would mean action by late February 2013, but J.P. Morgan’s Cory Kasimov indicated that approval could come earlier. The FDA has approved several drugs ahead of the user fee deadline over the past year.

That would be a welcome change for T-DM1 after the FDA refused to file Genentech’s accelerated approval application for the product in 2010. Indeed, the company made the refuse-to-file announcement exactly 2 years before announcing the overall survival benefit – Aug. 27, 2010.

That application was based on the results of one single-arm phase II trial in 110 patients. Tumors shrank in one-third of women with advanced HER2-positive breast cancer, who had received on average seven prior medicines, but the FDA said the filing did not meet the standards for accelerated approval because the company had not exhausted all available treatment options for metastatic breast cancer in the study population.

Roche plans to launch T-DM1 next year as a second-line therapy, although physicians are expected to use it as a first-line therapy, company officials said during an analyst briefing at ASCO in June.

T-DM1 is expected to eventually replace trastuzumab as the standard of care and as the cornerstone of Roche’s breast cancer portfolio. An early 2013 approval will give Roche time to establish the product before the introduction of trastuzumab biosimilars, expected in Europe in 2014 and in the United States in 2019.

The company is already studying T-DM1 in combination with pertuzumab (Perjeta), which could potentially eliminate the need for chemotherapy. Pertuzumab was approved in June for use with trastuzumab and chemotherapy in previously untreated HER2-positive metastatic breast cancer that has recurred after adjuvant or neoadjuvant therapy.

Roche also is expected to be among the first to test a new accelerated approval draft guidance using pathologic complete response to support accelerated approval in neoadjuvant breast cancer. It announced plans for a study testing T-DM1 and pertuzumab just after the draft guidance was released.

The company will face concerns about pricing, especially with the combination of the two targeted agents. But at an ASCO briefing, Roche COO Pascal Soriot pointed out that there will be safety advantages. "There will be a lot of savings for the systems and we need to price that in how we price T-DM1," he said.

Editor’s note: This story appears courtesy of "The Pink Sheet," a weekly Elsevier publication covering pharmaceutical business and policy issues. To learn more, contract customer care at 800-332-2181 or sign up for a free trial.

* This story was updated on 8/28/12 per clarification from Genentech.

Two years after the Food and Drug Administration refused to review T-DM1 for accelerated approval, Roche/Genentech Inc. has resubmitted the application with a statistically significant overall survival advantage in hand – FDA’s gold standard for oncology approvals.

The company announced Aug. 27 that it had submitted a biologics license application (BLA) to the FDA for the antibody drug conjugate trastuzumab emtansine, a combination of the monoclonal antibody trastuzumab (Herceptin) with the potent cytotoxic agent DM1, connected by a stable linker based on technology licensed from ImmunoGen Inc.

Genentech expects to submit a marketing authorization application to the European Medicines Agency soon.

[Editor’s note: Genentech has clarified that the updated overall survival analysis was not included in the initial BLA resubmission. It will be provided to FDA during its review of the application.]

The company also announced further results from the EMILIA study, showing T-DM1 had a statistically significant overall survival benefit in HER2-positive metastatic breast cancer, compared with GlaxoSmithKline Inc.’s lapatinib (Tykerb) in combination with capecitabine (Xeloda). Roche did not release actual figures, which will be presented at an upcoming medical meeting.

At the American Society for Clinical Oncology meeting in June, EMILIA authors showed a 3.2-month median progression-free survival benefit. Lead investigator Dr. Kimberly Blackwell, professor of medicine and assistant professor of radiation oncology at Duke Cancer Institute, Duke University, Durham, N.C., also said at the time there was a trend toward an overall survival improvement.

Analysts were not surprised at the news, given the progression-free survival advantage. J.P. Morgan said in an Aug. 27 note that its forecasts already expected a survival benefit in many treatment settings and that while markets reacted favorably to the news, ImmunoGen "already gets credit for this highly promising product."

Priority Review Expected

The positive data also should allow for a quick FDA approval. Priority review would mean action by late February 2013, but J.P. Morgan’s Cory Kasimov indicated that approval could come earlier. The FDA has approved several drugs ahead of the user fee deadline over the past year.

That would be a welcome change for T-DM1 after the FDA refused to file Genentech’s accelerated approval application for the product in 2010. Indeed, the company made the refuse-to-file announcement exactly 2 years before announcing the overall survival benefit – Aug. 27, 2010.

That application was based on the results of one single-arm phase II trial in 110 patients. Tumors shrank in one-third of women with advanced HER2-positive breast cancer, who had received on average seven prior medicines, but the FDA said the filing did not meet the standards for accelerated approval because the company had not exhausted all available treatment options for metastatic breast cancer in the study population.

Roche plans to launch T-DM1 next year as a second-line therapy, although physicians are expected to use it as a first-line therapy, company officials said during an analyst briefing at ASCO in June.

T-DM1 is expected to eventually replace trastuzumab as the standard of care and as the cornerstone of Roche’s breast cancer portfolio. An early 2013 approval will give Roche time to establish the product before the introduction of trastuzumab biosimilars, expected in Europe in 2014 and in the United States in 2019.

The company is already studying T-DM1 in combination with pertuzumab (Perjeta), which could potentially eliminate the need for chemotherapy. Pertuzumab was approved in June for use with trastuzumab and chemotherapy in previously untreated HER2-positive metastatic breast cancer that has recurred after adjuvant or neoadjuvant therapy.

Roche also is expected to be among the first to test a new accelerated approval draft guidance using pathologic complete response to support accelerated approval in neoadjuvant breast cancer. It announced plans for a study testing T-DM1 and pertuzumab just after the draft guidance was released.

The company will face concerns about pricing, especially with the combination of the two targeted agents. But at an ASCO briefing, Roche COO Pascal Soriot pointed out that there will be safety advantages. "There will be a lot of savings for the systems and we need to price that in how we price T-DM1," he said.

Editor’s note: This story appears courtesy of "The Pink Sheet," a weekly Elsevier publication covering pharmaceutical business and policy issues. To learn more, contract customer care at 800-332-2181 or sign up for a free trial.

* This story was updated on 8/28/12 per clarification from Genentech.

Two years after the Food and Drug Administration refused to review T-DM1 for accelerated approval, Roche/Genentech Inc. has resubmitted the application with a statistically significant overall survival advantage in hand – FDA’s gold standard for oncology approvals.

The company announced Aug. 27 that it had submitted a biologics license application (BLA) to the FDA for the antibody drug conjugate trastuzumab emtansine, a combination of the monoclonal antibody trastuzumab (Herceptin) with the potent cytotoxic agent DM1, connected by a stable linker based on technology licensed from ImmunoGen Inc.

Genentech expects to submit a marketing authorization application to the European Medicines Agency soon.

[Editor’s note: Genentech has clarified that the updated overall survival analysis was not included in the initial BLA resubmission. It will be provided to FDA during its review of the application.]

The company also announced further results from the EMILIA study, showing T-DM1 had a statistically significant overall survival benefit in HER2-positive metastatic breast cancer, compared with GlaxoSmithKline Inc.’s lapatinib (Tykerb) in combination with capecitabine (Xeloda). Roche did not release actual figures, which will be presented at an upcoming medical meeting.

At the American Society for Clinical Oncology meeting in June, EMILIA authors showed a 3.2-month median progression-free survival benefit. Lead investigator Dr. Kimberly Blackwell, professor of medicine and assistant professor of radiation oncology at Duke Cancer Institute, Duke University, Durham, N.C., also said at the time there was a trend toward an overall survival improvement.

Analysts were not surprised at the news, given the progression-free survival advantage. J.P. Morgan said in an Aug. 27 note that its forecasts already expected a survival benefit in many treatment settings and that while markets reacted favorably to the news, ImmunoGen "already gets credit for this highly promising product."

Priority Review Expected

The positive data also should allow for a quick FDA approval. Priority review would mean action by late February 2013, but J.P. Morgan’s Cory Kasimov indicated that approval could come earlier. The FDA has approved several drugs ahead of the user fee deadline over the past year.

That would be a welcome change for T-DM1 after the FDA refused to file Genentech’s accelerated approval application for the product in 2010. Indeed, the company made the refuse-to-file announcement exactly 2 years before announcing the overall survival benefit – Aug. 27, 2010.

That application was based on the results of one single-arm phase II trial in 110 patients. Tumors shrank in one-third of women with advanced HER2-positive breast cancer, who had received on average seven prior medicines, but the FDA said the filing did not meet the standards for accelerated approval because the company had not exhausted all available treatment options for metastatic breast cancer in the study population.

Roche plans to launch T-DM1 next year as a second-line therapy, although physicians are expected to use it as a first-line therapy, company officials said during an analyst briefing at ASCO in June.

T-DM1 is expected to eventually replace trastuzumab as the standard of care and as the cornerstone of Roche’s breast cancer portfolio. An early 2013 approval will give Roche time to establish the product before the introduction of trastuzumab biosimilars, expected in Europe in 2014 and in the United States in 2019.

The company is already studying T-DM1 in combination with pertuzumab (Perjeta), which could potentially eliminate the need for chemotherapy. Pertuzumab was approved in June for use with trastuzumab and chemotherapy in previously untreated HER2-positive metastatic breast cancer that has recurred after adjuvant or neoadjuvant therapy.

Roche also is expected to be among the first to test a new accelerated approval draft guidance using pathologic complete response to support accelerated approval in neoadjuvant breast cancer. It announced plans for a study testing T-DM1 and pertuzumab just after the draft guidance was released.

The company will face concerns about pricing, especially with the combination of the two targeted agents. But at an ASCO briefing, Roche COO Pascal Soriot pointed out that there will be safety advantages. "There will be a lot of savings for the systems and we need to price that in how we price T-DM1," he said.

Editor’s note: This story appears courtesy of "The Pink Sheet," a weekly Elsevier publication covering pharmaceutical business and policy issues. To learn more, contract customer care at 800-332-2181 or sign up for a free trial.

* This story was updated on 8/28/12 per clarification from Genentech.

Persistent cardiovascular events across the clinical trials for aclidinium bromide may not represent a definite safety signal, according to the Food and Drug Administration, but there is enough concern that an advisory committee will be asked for input on its significance.

The drug’s maker, Forest Laboratories Inc., wants approval of aclidinium bromide for long-term maintenance treatment of bronchospasm from chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. It comes as a dry powder and is dispersed through an inhaler from Almirall SA.

When the FDA’s Pulmonary-Allergy Drugs Advisory Committee considers the product on Feb. 23, the agency wants the panel to discuss the overall safety profile, given the size of the safety database and duration of exposure. The committee also will vote on whether safety has been adequately assessed for the proposed indication.

FDA reviewers identified 10 cardiovascular deaths among patients in aclidinium clinical trials who were treated with the desired 400-mcg dose.

Four of those deaths were caused by cardiac arrest and one was from acute cardiac failure, while only one case of myocardial infarction was reported in patients receiving a 200-mcg dose of aclidinium bromide. None was reported among those receiving placebo. A cardiovascular cause could not be ruled out in two placebo cases, according to FDA documents.

The clinical reviewer said that the significance of the findings is uncertain, but called it "striking" that all the CV deaths in the long-term safety trial were in the 400 mcg–dose group.

Still, the agency said that the incidence rate in the group is lower than would generally be expected in a "real world" COPD population.

"It is difficult to dismiss the apparent imbalance in cardiovascular death between the treatment groups, while at the same time, impossible to conclude that the data represent a true safety signal," the clinical briefing documents conclude.

The size of the safety database was concerning to the FDA. Across all Forest’s trials, 1,471 patients with COPD were exposed to the 400-mcg dose with a mean duration of 211 days, including 733 patients exposed for 182 days or more and 329 exposed for 1 year.

The agency said the size was consistent with international guidelines but was "relatively small compared to the size of programs for other COPD products."

Long-term data combined with additional exposure data suggest that the CV death was possibly dose dependent, the agency said.

"Whether these results represent a spurious finding or a potential safety signal is difficult to discern and may warrant further investigation," the FDA stated.

FDA said the issue is particularly important given the possibility of increased mortality that has been identified with other inhaled anticholinergic agents.

Last year, the FDA ordered large studies of four long-acting beta agonists (LABAs) to assess their safety when used with inhaled corticosteroids versus inhaled corticosteroids alone. It was an outgrowth of a reanalysis of trial data that found LABA use can be associated with severe asthma symptoms, hospitalization, and death.

The FDA said that the reanalysis could be interpreted in different ways and decided new studies were needed.

If the committee decides aclidinium bromide’s safety has not been assessed adequately, it will be asked what other data should be obtained.

Efficacy Data Not Questioned

FDA reviewers did not have any doubts about whether aclidinium bromide’s efficacy had been demonstrated in the three trials that were submitted. The agency said a statistically significant effect compared with placebo was found for the 400-mcg dose, as well as a smaller significant effect for a 200-mcg dose, after 12 weeks of treatment.

The effect from the 400-mcg dose also seemed to persist at week 24 in one of the trials. Subgroup analyses showed effects similar to the overall population, according to FDA briefing documents.

Secondary endpoints such as peak forced expiratory volume in 1 second and rescue medication usage patterns also supported efficacy.

The committee will discuss aclidinium bromide’s efficacy, including its bronchodilatory effect, and vote on whether the efficacy data provide substantial evidence of a clinically meaningful benefit for the 400-mcg dose, which would be given twice daily.

The final voting question asks whether the efficacy and safety data provide substantial evidence for approval.

Forest has proposed the trade name Tudorza Pressair for the pending product.

This coverage is provided courtesy of "The Pink Sheet." Elsevier Global Medical News and "The Pink Sheet" are published by Elsevier.

Persistent cardiovascular events across the clinical trials for aclidinium bromide may not represent a definite safety signal, according to the Food and Drug Administration, but there is enough concern that an advisory committee will be asked for input on its significance.

The drug’s maker, Forest Laboratories Inc., wants approval of aclidinium bromide for long-term maintenance treatment of bronchospasm from chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. It comes as a dry powder and is dispersed through an inhaler from Almirall SA.

When the FDA’s Pulmonary-Allergy Drugs Advisory Committee considers the product on Feb. 23, the agency wants the panel to discuss the overall safety profile, given the size of the safety database and duration of exposure. The committee also will vote on whether safety has been adequately assessed for the proposed indication.

FDA reviewers identified 10 cardiovascular deaths among patients in aclidinium clinical trials who were treated with the desired 400-mcg dose.

Four of those deaths were caused by cardiac arrest and one was from acute cardiac failure, while only one case of myocardial infarction was reported in patients receiving a 200-mcg dose of aclidinium bromide. None was reported among those receiving placebo. A cardiovascular cause could not be ruled out in two placebo cases, according to FDA documents.

The clinical reviewer said that the significance of the findings is uncertain, but called it "striking" that all the CV deaths in the long-term safety trial were in the 400 mcg–dose group.

Still, the agency said that the incidence rate in the group is lower than would generally be expected in a "real world" COPD population.

"It is difficult to dismiss the apparent imbalance in cardiovascular death between the treatment groups, while at the same time, impossible to conclude that the data represent a true safety signal," the clinical briefing documents conclude.

The size of the safety database was concerning to the FDA. Across all Forest’s trials, 1,471 patients with COPD were exposed to the 400-mcg dose with a mean duration of 211 days, including 733 patients exposed for 182 days or more and 329 exposed for 1 year.

The agency said the size was consistent with international guidelines but was "relatively small compared to the size of programs for other COPD products."

Long-term data combined with additional exposure data suggest that the CV death was possibly dose dependent, the agency said.

"Whether these results represent a spurious finding or a potential safety signal is difficult to discern and may warrant further investigation," the FDA stated.

FDA said the issue is particularly important given the possibility of increased mortality that has been identified with other inhaled anticholinergic agents.

Last year, the FDA ordered large studies of four long-acting beta agonists (LABAs) to assess their safety when used with inhaled corticosteroids versus inhaled corticosteroids alone. It was an outgrowth of a reanalysis of trial data that found LABA use can be associated with severe asthma symptoms, hospitalization, and death.

The FDA said that the reanalysis could be interpreted in different ways and decided new studies were needed.

If the committee decides aclidinium bromide’s safety has not been assessed adequately, it will be asked what other data should be obtained.

Efficacy Data Not Questioned

FDA reviewers did not have any doubts about whether aclidinium bromide’s efficacy had been demonstrated in the three trials that were submitted. The agency said a statistically significant effect compared with placebo was found for the 400-mcg dose, as well as a smaller significant effect for a 200-mcg dose, after 12 weeks of treatment.

The effect from the 400-mcg dose also seemed to persist at week 24 in one of the trials. Subgroup analyses showed effects similar to the overall population, according to FDA briefing documents.

Secondary endpoints such as peak forced expiratory volume in 1 second and rescue medication usage patterns also supported efficacy.

The committee will discuss aclidinium bromide’s efficacy, including its bronchodilatory effect, and vote on whether the efficacy data provide substantial evidence of a clinically meaningful benefit for the 400-mcg dose, which would be given twice daily.

The final voting question asks whether the efficacy and safety data provide substantial evidence for approval.

Forest has proposed the trade name Tudorza Pressair for the pending product.

This coverage is provided courtesy of "The Pink Sheet." Elsevier Global Medical News and "The Pink Sheet" are published by Elsevier.

Persistent cardiovascular events across the clinical trials for aclidinium bromide may not represent a definite safety signal, according to the Food and Drug Administration, but there is enough concern that an advisory committee will be asked for input on its significance.

The drug’s maker, Forest Laboratories Inc., wants approval of aclidinium bromide for long-term maintenance treatment of bronchospasm from chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. It comes as a dry powder and is dispersed through an inhaler from Almirall SA.

When the FDA’s Pulmonary-Allergy Drugs Advisory Committee considers the product on Feb. 23, the agency wants the panel to discuss the overall safety profile, given the size of the safety database and duration of exposure. The committee also will vote on whether safety has been adequately assessed for the proposed indication.

FDA reviewers identified 10 cardiovascular deaths among patients in aclidinium clinical trials who were treated with the desired 400-mcg dose.

Four of those deaths were caused by cardiac arrest and one was from acute cardiac failure, while only one case of myocardial infarction was reported in patients receiving a 200-mcg dose of aclidinium bromide. None was reported among those receiving placebo. A cardiovascular cause could not be ruled out in two placebo cases, according to FDA documents.

The clinical reviewer said that the significance of the findings is uncertain, but called it "striking" that all the CV deaths in the long-term safety trial were in the 400 mcg–dose group.

Still, the agency said that the incidence rate in the group is lower than would generally be expected in a "real world" COPD population.

"It is difficult to dismiss the apparent imbalance in cardiovascular death between the treatment groups, while at the same time, impossible to conclude that the data represent a true safety signal," the clinical briefing documents conclude.

The size of the safety database was concerning to the FDA. Across all Forest’s trials, 1,471 patients with COPD were exposed to the 400-mcg dose with a mean duration of 211 days, including 733 patients exposed for 182 days or more and 329 exposed for 1 year.

The agency said the size was consistent with international guidelines but was "relatively small compared to the size of programs for other COPD products."

Long-term data combined with additional exposure data suggest that the CV death was possibly dose dependent, the agency said.

"Whether these results represent a spurious finding or a potential safety signal is difficult to discern and may warrant further investigation," the FDA stated.

FDA said the issue is particularly important given the possibility of increased mortality that has been identified with other inhaled anticholinergic agents.

Last year, the FDA ordered large studies of four long-acting beta agonists (LABAs) to assess their safety when used with inhaled corticosteroids versus inhaled corticosteroids alone. It was an outgrowth of a reanalysis of trial data that found LABA use can be associated with severe asthma symptoms, hospitalization, and death.

The FDA said that the reanalysis could be interpreted in different ways and decided new studies were needed.

If the committee decides aclidinium bromide’s safety has not been assessed adequately, it will be asked what other data should be obtained.

Efficacy Data Not Questioned

FDA reviewers did not have any doubts about whether aclidinium bromide’s efficacy had been demonstrated in the three trials that were submitted. The agency said a statistically significant effect compared with placebo was found for the 400-mcg dose, as well as a smaller significant effect for a 200-mcg dose, after 12 weeks of treatment.

The effect from the 400-mcg dose also seemed to persist at week 24 in one of the trials. Subgroup analyses showed effects similar to the overall population, according to FDA briefing documents.

Secondary endpoints such as peak forced expiratory volume in 1 second and rescue medication usage patterns also supported efficacy.

The committee will discuss aclidinium bromide’s efficacy, including its bronchodilatory effect, and vote on whether the efficacy data provide substantial evidence of a clinically meaningful benefit for the 400-mcg dose, which would be given twice daily.

The final voting question asks whether the efficacy and safety data provide substantial evidence for approval.

Forest has proposed the trade name Tudorza Pressair for the pending product.

This coverage is provided courtesy of "The Pink Sheet." Elsevier Global Medical News and "The Pink Sheet" are published by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

Legislative fixes are required for the Food and Drug Administration to implement its long-term strategy to use a coalition of regulators to secure the world drug supply chain, but the agency says it will not let that stop it from implementing its Pathway to Global Product Safety and Quality plan.

The agency is looking for authority over the drug industry similar to the authority it was given over the food industry by the Food Safety Modernization Act, which included the ability to place preventive controls across the supply chain and potential penalties for noncompliance.

FDA officials were not very specific when discussing the new authority needed on the drug side during a formal announcement of the globalization plan on June 20.

A likely vehicle for the expanded supply chain authority is the omnibus user fee bill currently under negotiation, which will include the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act reauthorizations.

Plan Has Been Discussed Before

The globalization plan will change the FDA’s thinking about how it conducts business in the global marketplace. Rather than relying on its own staff to conduct inspections and ensure that facilities are following FDA standards, the plan calls for the agency to rely more on other regulators as well as certified third parties to conduct inspections so that resources can be used more effectively.

Increases in medical products that are imported into the United States are outstripping resources, and simply scaling up to meet rising demand is not an option, the agency concluded in the report.

Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said one area of improvement needed for the globalization plan is the ability to share information with other regulators.

"Right now, we are not able to share as freely as we might like because of legislative restrictions relating to sharing of trade secret information, and that’s something I know Congress has taken a look at," Ms. Autor said during the announcement. "With that restriction, we can continue to share, and we do effectively, but it leads to delays associated with redaction and potentially less transparency between us and our counterparts."

FDA officials have been talking about the globalization plan in various settings for a few months. The formal announcement coincided with the release of an agency report describing the circumstances the FDA is facing that necessitate the changes. It also comes as the agency faces essentially no budget increase in fiscal year 2012, which could curtail the plan’s implementation.

FDA Commissioner Margaret Hamburg maintained during the announcement that the plan is a long-term strategy that will take years to implement. John M. Taylor, acting Principal Deputy Commissioner of Food and Drugs, said specific resource estimates have not been completed.

Forming a Regulators Coalition

The FDA is expected to focus on forming the coalition of mature regulators in the next year. Group members would be allowed to share data and standardize manufacturing requirements and inspection procedures, according to the report. Members also would focus on establishing a system that ensures comparability of results throughout the coalition.

The FDA already has agreements with regulators in several countries that allow for information sharing. The agency recently announced that it was making permanent a joint-inspection program with the European Medicines Agency and the Australian Therapeutic Goods Administration.

The program addressed Good Manufacturing Practices for active pharmaceutical ingredient manufacturers. Results were shared among the three agencies in the hope of freeing resources for other needs.

But Mr. Taylor clarified that the coalition envisioned in the globalization plan does not already exist in the agency’s regulatory experience.

"What we’re contemplating is not an effort solely funded by FDA or any other organization, but instead an effort where all of us contribute in a way that allows us to leverage our limited resources," he said. "Many of our peer regulators are similarly situated and they too have expressed a desire to look at new ways to work more closely together, more quickly, so that we can address these complex challenges."

The plan also calls for the agency to engage with countries with emerging economies that would not qualify as part of the group, to help ensure they also commit to accepted practices.

This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are both owned by Elsevier.

The Food and Drug Administration is asking an advisory committee to consider the full gamut of options for how to deal with Trilipix and its combination with a statin in the wake of the results of the ACCORD-Lipid trial.

The Endocrinologic and Metabolic Drugs Advisory Committee on May 19 will discuss whether the FDA should withdraw approval for coadministration of Abbott’s drug with a statin to lower triglyceride levels; continue to allow marketing, but revise the label to incorporate the Action to Control Cardiovascular Risk in Diabetes-Lipid trial findings; or continue marketing with the existing label. The possibility of requiring a clinical trial to test a hypothesis that Trilipix could benefit a subgroup also is up for consideration.

The FDA’s draft questions posted May 17 split the question, asking the members to vote on the need for another trial and then to vote for status quo, withdrawal or a narrowed indication.

Trilipix (fenofibric acid) is a follow-on to Abbott’s TriCor (fenofibrate) and was approved in December 2008, gaining an indication as the only fibrate that could be used with a statin. It also has been approved as monotherapy for a number of conditions.

Most of the options before the panel could lessen the drug’s advantage over generic competitors:

ACCORD Efficacy and Trilipix Safety to Be Evaluated

The government-funded ACCORD trial studied whether adding fibrate to simvastatin therapy in patients with type 2 diabetes would reduce the rate of cardiovascular disease events in high-risk patients, compared with simvastatin monotherapy.

The results, released in March 2010, showed no difference in CV outcomes. They also suggested the therapy might only be appropriate for a minority of diabetes patients.

Abbott has already been set back on one product by ACCORD: the fixed-dose combination of Trilipix and AstraZeneca’s Crestor (rosuvastatin) received a "complete response" letter in March 2010.

The committee is being asked to interpret the primary efficacy results of ACCORD-Lipid in relation to Trilipix’s coadministration indication.

Subgroup Success and Failure?

The FDA did identify one group that might benefit from fenofibrate plus statin therapy: patients with high triglyceride levels (greater than or equal to 204 mg/dL in the trial) and low high-density lipoprotein cholesterol (less than or equal to 34 mg/dL). A prespecified subgroup analysis showed 12.4% of patients in the group on fenofibrate plus Merck’s Zocor (simvastatin) had major adverse cardiac events, versus 17.3% on simvastatin monotherapy.

Abbott seems prepared for the indication to be limited. In its briefing document, the company maintains the data show coadministration of Trilipix and a statin has a favorable benefit-risk profile in that group. The combination "remains an important therapeutic option for appropriately selected patients," the company says.

Advisory committee members also will be asked to give their interpretation of the subgroup analysis and how it relates to use of Trilipix plus statin therapy.

In addition, the committee will be asked for its opinion of the study’s finding that women receiving fenofibrate plus simvastatin had a higher major adverse cardiovascular event incidence rate (9.1%) than those only on simvastatin (6.6%). The clinical significance of the finding is unclear, FDA said in a Federal Register notice announcing the advisory committee meeting.

FDA admitted there remain several questions about fibrates and suggested another study could provide more answers about performance, especially within the subgroups.

"One way to obtain a more definitive answer to the question of fenofibrate’s cardiovascular benefit when added to a statin is to conduct a clinical trial specifically designed to test the hypothesis that, in high-risk men and women at LDL-C goal on a statin with residually high TG and low HDL-C, treatment with fenofibrate versus placebo significantly reduces the risk for major adverse cardiovascular events," the agency’s briefing material states. "Such a trial would also provide additional information regarding the cardiovascular effects of fenofibrate plus statin versus statin monotherapy in women versus men."

"The Pink Sheet" and this news organization are owned by Elsevier.

The Food and Drug Administration is asking an advisory committee to consider the full gamut of options for how to deal with Trilipix and its combination with a statin in the wake of the results of the ACCORD-Lipid trial.

The Endocrinologic and Metabolic Drugs Advisory Committee on May 19 will discuss whether the FDA should withdraw approval for coadministration of Abbott’s drug with a statin to lower triglyceride levels; continue to allow marketing, but revise the label to incorporate the Action to Control Cardiovascular Risk in Diabetes-Lipid trial findings; or continue marketing with the existing label. The possibility of requiring a clinical trial to test a hypothesis that Trilipix could benefit a subgroup also is up for consideration.

The FDA’s draft questions posted May 17 split the question, asking the members to vote on the need for another trial and then to vote for status quo, withdrawal or a narrowed indication.

Trilipix (fenofibric acid) is a follow-on to Abbott’s TriCor (fenofibrate) and was approved in December 2008, gaining an indication as the only fibrate that could be used with a statin. It also has been approved as monotherapy for a number of conditions.

Most of the options before the panel could lessen the drug’s advantage over generic competitors:

ACCORD Efficacy and Trilipix Safety to Be Evaluated

The government-funded ACCORD trial studied whether adding fibrate to simvastatin therapy in patients with type 2 diabetes would reduce the rate of cardiovascular disease events in high-risk patients, compared with simvastatin monotherapy.

The results, released in March 2010, showed no difference in CV outcomes. They also suggested the therapy might only be appropriate for a minority of diabetes patients.

Abbott has already been set back on one product by ACCORD: the fixed-dose combination of Trilipix and AstraZeneca’s Crestor (rosuvastatin) received a "complete response" letter in March 2010.

The committee is being asked to interpret the primary efficacy results of ACCORD-Lipid in relation to Trilipix’s coadministration indication.

Subgroup Success and Failure?

The FDA did identify one group that might benefit from fenofibrate plus statin therapy: patients with high triglyceride levels (greater than or equal to 204 mg/dL in the trial) and low high-density lipoprotein cholesterol (less than or equal to 34 mg/dL). A prespecified subgroup analysis showed 12.4% of patients in the group on fenofibrate plus Merck’s Zocor (simvastatin) had major adverse cardiac events, versus 17.3% on simvastatin monotherapy.

Abbott seems prepared for the indication to be limited. In its briefing document, the company maintains the data show coadministration of Trilipix and a statin has a favorable benefit-risk profile in that group. The combination "remains an important therapeutic option for appropriately selected patients," the company says.

Advisory committee members also will be asked to give their interpretation of the subgroup analysis and how it relates to use of Trilipix plus statin therapy.

In addition, the committee will be asked for its opinion of the study’s finding that women receiving fenofibrate plus simvastatin had a higher major adverse cardiovascular event incidence rate (9.1%) than those only on simvastatin (6.6%). The clinical significance of the finding is unclear, FDA said in a Federal Register notice announcing the advisory committee meeting.

FDA admitted there remain several questions about fibrates and suggested another study could provide more answers about performance, especially within the subgroups.

"One way to obtain a more definitive answer to the question of fenofibrate’s cardiovascular benefit when added to a statin is to conduct a clinical trial specifically designed to test the hypothesis that, in high-risk men and women at LDL-C goal on a statin with residually high TG and low HDL-C, treatment with fenofibrate versus placebo significantly reduces the risk for major adverse cardiovascular events," the agency’s briefing material states. "Such a trial would also provide additional information regarding the cardiovascular effects of fenofibrate plus statin versus statin monotherapy in women versus men."

"The Pink Sheet" and this news organization are owned by Elsevier.

The Food and Drug Administration is asking an advisory committee to consider the full gamut of options for how to deal with Trilipix and its combination with a statin in the wake of the results of the ACCORD-Lipid trial.

The Endocrinologic and Metabolic Drugs Advisory Committee on May 19 will discuss whether the FDA should withdraw approval for coadministration of Abbott’s drug with a statin to lower triglyceride levels; continue to allow marketing, but revise the label to incorporate the Action to Control Cardiovascular Risk in Diabetes-Lipid trial findings; or continue marketing with the existing label. The possibility of requiring a clinical trial to test a hypothesis that Trilipix could benefit a subgroup also is up for consideration.

The FDA’s draft questions posted May 17 split the question, asking the members to vote on the need for another trial and then to vote for status quo, withdrawal or a narrowed indication.

Trilipix (fenofibric acid) is a follow-on to Abbott’s TriCor (fenofibrate) and was approved in December 2008, gaining an indication as the only fibrate that could be used with a statin. It also has been approved as monotherapy for a number of conditions.

Most of the options before the panel could lessen the drug’s advantage over generic competitors:

ACCORD Efficacy and Trilipix Safety to Be Evaluated

The government-funded ACCORD trial studied whether adding fibrate to simvastatin therapy in patients with type 2 diabetes would reduce the rate of cardiovascular disease events in high-risk patients, compared with simvastatin monotherapy.

The results, released in March 2010, showed no difference in CV outcomes. They also suggested the therapy might only be appropriate for a minority of diabetes patients.

Abbott has already been set back on one product by ACCORD: the fixed-dose combination of Trilipix and AstraZeneca’s Crestor (rosuvastatin) received a "complete response" letter in March 2010.

The committee is being asked to interpret the primary efficacy results of ACCORD-Lipid in relation to Trilipix’s coadministration indication.

Subgroup Success and Failure?

The FDA did identify one group that might benefit from fenofibrate plus statin therapy: patients with high triglyceride levels (greater than or equal to 204 mg/dL in the trial) and low high-density lipoprotein cholesterol (less than or equal to 34 mg/dL). A prespecified subgroup analysis showed 12.4% of patients in the group on fenofibrate plus Merck’s Zocor (simvastatin) had major adverse cardiac events, versus 17.3% on simvastatin monotherapy.

Abbott seems prepared for the indication to be limited. In its briefing document, the company maintains the data show coadministration of Trilipix and a statin has a favorable benefit-risk profile in that group. The combination "remains an important therapeutic option for appropriately selected patients," the company says.

Advisory committee members also will be asked to give their interpretation of the subgroup analysis and how it relates to use of Trilipix plus statin therapy.

In addition, the committee will be asked for its opinion of the study’s finding that women receiving fenofibrate plus simvastatin had a higher major adverse cardiovascular event incidence rate (9.1%) than those only on simvastatin (6.6%). The clinical significance of the finding is unclear, FDA said in a Federal Register notice announcing the advisory committee meeting.

FDA admitted there remain several questions about fibrates and suggested another study could provide more answers about performance, especially within the subgroups.

"One way to obtain a more definitive answer to the question of fenofibrate’s cardiovascular benefit when added to a statin is to conduct a clinical trial specifically designed to test the hypothesis that, in high-risk men and women at LDL-C goal on a statin with residually high TG and low HDL-C, treatment with fenofibrate versus placebo significantly reduces the risk for major adverse cardiovascular events," the agency’s briefing material states. "Such a trial would also provide additional information regarding the cardiovascular effects of fenofibrate plus statin versus statin monotherapy in women versus men."

"The Pink Sheet" and this news organization are owned by Elsevier.

The Food and Drug Administration is asking an advisory committee to consider the full gamut of options for how to deal with Trilipix and its combination with a statin in the wake of the results of the ACCORD-Lipid trial.

The Endocrinologic and Metabolic Drugs Advisory Committee on May 19 will discuss whether the FDA should withdraw approval for coadministration of Abbott’s drug with a statin to lower triglyceride levels; continue to allow marketing, but revise the label to incorporate the Action to Control Cardiovascular Risk in Diabetes-Lipid trial findings; or continue marketing with the existing label. The possibility of requiring a clinical trial to test a hypothesis that Trilipix could benefit a subgroup also is up for consideration.

The FDA’s draft questions posted May 17 split the question, asking the members to vote on the need for another trial and then to vote for status quo, withdrawal or a narrowed indication.

Trilipix (fenofibric acid) is a follow-on to Abbott’s TriCor (fenofibrate) and was approved in December 2008, gaining an indication as the only fibrate that could be used with a statin. It also has been approved as monotherapy for a number of conditions.

Most of the options before the panel could lessen the drug’s advantage over generic competitors:

ACCORD Efficacy and Trilipix Safety to Be Evaluated

The government-funded ACCORD trial studied whether adding fibrate to simvastatin therapy in patients with type 2 diabetes would reduce the rate of cardiovascular disease events in high-risk patients, compared with simvastatin monotherapy.

The results, released in March 2010, showed no difference in CV outcomes. They also suggested the therapy might only be appropriate for a minority of diabetes patients.

Abbott has already been set back on one product by ACCORD: the fixed-dose combination of Trilipix and AstraZeneca’s Crestor (rosuvastatin) received a "complete response" letter in March 2010.

The committee is being asked to interpret the primary efficacy results of ACCORD-Lipid in relation to Trilipix’s coadministration indication.

Subgroup Success and Failure?

The FDA did identify one group that might benefit from fenofibrate plus statin therapy: patients with high triglyceride levels (greater than or equal to 204 mg/dL in the trial) and low high-density lipoprotein cholesterol (less than or equal to 34 mg/dL). A prespecified subgroup analysis showed 12.4% of patients in the group on fenofibrate plus Merck’s Zocor (simvastatin) had major adverse cardiac events, versus 17.3% on simvastatin monotherapy.

Abbott seems prepared for the indication to be limited. In its briefing document, the company maintains the data show coadministration of Trilipix and a statin has a favorable benefit-risk profile in that group. The combination "remains an important therapeutic option for appropriately selected patients," the company says.

Advisory committee members also will be asked to give their interpretation of the subgroup analysis and how it relates to use of Trilipix plus statin therapy.

In addition, the committee will be asked for its opinion of the study’s finding that women receiving fenofibrate plus simvastatin had a higher major adverse cardiovascular event incidence rate (9.1%) than those only on simvastatin (6.6%). The clinical significance of the finding is unclear, FDA said in a Federal Register notice announcing the advisory committee meeting.

FDA admitted there remain several questions about fibrates and suggested another study could provide more answers about performance, especially within the subgroups.

"One way to obtain a more definitive answer to the question of fenofibrate’s cardiovascular benefit when added to a statin is to conduct a clinical trial specifically designed to test the hypothesis that, in high-risk men and women at LDL-C goal on a statin with residually high TG and low HDL-C, treatment with fenofibrate versus placebo significantly reduces the risk for major adverse cardiovascular events," the agency’s briefing material states. "Such a trial would also provide additional information regarding the cardiovascular effects of fenofibrate plus statin versus statin monotherapy in women versus men."

"The Pink Sheet" and this news organization are owned by Elsevier.

The Food and Drug Administration is asking an advisory committee to consider the full gamut of options for how to deal with Trilipix and its combination with a statin in the wake of the results of the ACCORD-Lipid trial.

The Endocrinologic and Metabolic Drugs Advisory Committee on May 19 will discuss whether the FDA should withdraw approval for coadministration of Abbott’s drug with a statin to lower triglyceride levels; continue to allow marketing, but revise the label to incorporate the Action to Control Cardiovascular Risk in Diabetes-Lipid trial findings; or continue marketing with the existing label. The possibility of requiring a clinical trial to test a hypothesis that Trilipix could benefit a subgroup also is up for consideration.

The FDA’s draft questions posted May 17 split the question, asking the members to vote on the need for another trial and then to vote for status quo, withdrawal or a narrowed indication.

Trilipix (fenofibric acid) is a follow-on to Abbott’s TriCor (fenofibrate) and was approved in December 2008, gaining an indication as the only fibrate that could be used with a statin. It also has been approved as monotherapy for a number of conditions.

Most of the options before the panel could lessen the drug’s advantage over generic competitors:

ACCORD Efficacy and Trilipix Safety to Be Evaluated

The government-funded ACCORD trial studied whether adding fibrate to simvastatin therapy in patients with type 2 diabetes would reduce the rate of cardiovascular disease events in high-risk patients, compared with simvastatin monotherapy.

The results, released in March 2010, showed no difference in CV outcomes. They also suggested the therapy might only be appropriate for a minority of diabetes patients.

Abbott has already been set back on one product by ACCORD: the fixed-dose combination of Trilipix and AstraZeneca’s Crestor (rosuvastatin) received a "complete response" letter in March 2010.

The committee is being asked to interpret the primary efficacy results of ACCORD-Lipid in relation to Trilipix’s coadministration indication.

Subgroup Success and Failure?

The FDA did identify one group that might benefit from fenofibrate plus statin therapy: patients with high triglyceride levels (greater than or equal to 204 mg/dL in the trial) and low high-density lipoprotein cholesterol (less than or equal to 34 mg/dL). A prespecified subgroup analysis showed 12.4% of patients in the group on fenofibrate plus Merck’s Zocor (simvastatin) had major adverse cardiac events, versus 17.3% on simvastatin monotherapy.

Abbott seems prepared for the indication to be limited. In its briefing document, the company maintains the data show coadministration of Trilipix and a statin has a favorable benefit-risk profile in that group. The combination "remains an important therapeutic option for appropriately selected patients," the company says.

Advisory committee members also will be asked to give their interpretation of the subgroup analysis and how it relates to use of Trilipix plus statin therapy.

In addition, the committee will be asked for its opinion of the study’s finding that women receiving fenofibrate plus simvastatin had a higher major adverse cardiovascular event incidence rate (9.1%) than those only on simvastatin (6.6%). The clinical significance of the finding is unclear, FDA said in a Federal Register notice announcing the advisory committee meeting.

FDA admitted there remain several questions about fibrates and suggested another study could provide more answers about performance, especially within the subgroups.

"One way to obtain a more definitive answer to the question of fenofibrate’s cardiovascular benefit when added to a statin is to conduct a clinical trial specifically designed to test the hypothesis that, in high-risk men and women at LDL-C goal on a statin with residually high TG and low HDL-C, treatment with fenofibrate versus placebo significantly reduces the risk for major adverse cardiovascular events," the agency’s briefing material states. "Such a trial would also provide additional information regarding the cardiovascular effects of fenofibrate plus statin versus statin monotherapy in women versus men."

"The Pink Sheet" and this news organization are owned by Elsevier.

The Food and Drug Administration is asking an advisory committee to consider the full gamut of options for how to deal with Trilipix and its combination with a statin in the wake of the results of the ACCORD-Lipid trial.

The Endocrinologic and Metabolic Drugs Advisory Committee on May 19 will discuss whether the FDA should withdraw approval for coadministration of Abbott’s drug with a statin to lower triglyceride levels; continue to allow marketing, but revise the label to incorporate the Action to Control Cardiovascular Risk in Diabetes-Lipid trial findings; or continue marketing with the existing label. The possibility of requiring a clinical trial to test a hypothesis that Trilipix could benefit a subgroup also is up for consideration.

The FDA’s draft questions posted May 17 split the question, asking the members to vote on the need for another trial and then to vote for status quo, withdrawal or a narrowed indication.

Trilipix (fenofibric acid) is a follow-on to Abbott’s TriCor (fenofibrate) and was approved in December 2008, gaining an indication as the only fibrate that could be used with a statin. It also has been approved as monotherapy for a number of conditions.

Most of the options before the panel could lessen the drug’s advantage over generic competitors:

ACCORD Efficacy and Trilipix Safety to Be Evaluated

The government-funded ACCORD trial studied whether adding fibrate to simvastatin therapy in patients with type 2 diabetes would reduce the rate of cardiovascular disease events in high-risk patients, compared with simvastatin monotherapy.

The results, released in March 2010, showed no difference in CV outcomes. They also suggested the therapy might only be appropriate for a minority of diabetes patients.

Abbott has already been set back on one product by ACCORD: the fixed-dose combination of Trilipix and AstraZeneca’s Crestor (rosuvastatin) received a "complete response" letter in March 2010.

The committee is being asked to interpret the primary efficacy results of ACCORD-Lipid in relation to Trilipix’s coadministration indication.

Subgroup Success and Failure?

The FDA did identify one group that might benefit from fenofibrate plus statin therapy: patients with high triglyceride levels (greater than or equal to 204 mg/dL in the trial) and low high-density lipoprotein cholesterol (less than or equal to 34 mg/dL). A prespecified subgroup analysis showed 12.4% of patients in the group on fenofibrate plus Merck’s Zocor (simvastatin) had major adverse cardiac events, versus 17.3% on simvastatin monotherapy.

Abbott seems prepared for the indication to be limited. In its briefing document, the company maintains the data show coadministration of Trilipix and a statin has a favorable benefit-risk profile in that group. The combination "remains an important therapeutic option for appropriately selected patients," the company says.

Advisory committee members also will be asked to give their interpretation of the subgroup analysis and how it relates to use of Trilipix plus statin therapy.

In addition, the committee will be asked for its opinion of the study’s finding that women receiving fenofibrate plus simvastatin had a higher major adverse cardiovascular event incidence rate (9.1%) than those only on simvastatin (6.6%). The clinical significance of the finding is unclear, FDA said in a Federal Register notice announcing the advisory committee meeting.

FDA admitted there remain several questions about fibrates and suggested another study could provide more answers about performance, especially within the subgroups.

"One way to obtain a more definitive answer to the question of fenofibrate’s cardiovascular benefit when added to a statin is to conduct a clinical trial specifically designed to test the hypothesis that, in high-risk men and women at LDL-C goal on a statin with residually high TG and low HDL-C, treatment with fenofibrate versus placebo significantly reduces the risk for major adverse cardiovascular events," the agency’s briefing material states. "Such a trial would also provide additional information regarding the cardiovascular effects of fenofibrate plus statin versus statin monotherapy in women versus men."

"The Pink Sheet" and this news organization are owned by Elsevier.