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Adverse Event Reporting Criticized
Little information is made public about adverse events in hospitals, even though public disclosure can help clinicians improve patient safety, according to a government report. After reviewing 8 federally approved patient safety organizations and 17 systems that collect adverse event information for states, the Department of Health and Human Services Inspector General found that only 7 state systems passed along to providers adverse event analyses that led to changes in practice. The other states passed along reports without any analysis. A nationwide database of adverse events collected by the patient safety organizations won't be operational until at least 2011, the report said.
Tobacco Act Takes a Hit
A federal district court has struck down parts of the Family Smoking Prevention and Tobacco Control Act of 2009, saying that some of the landmark law violates tobacco makers' free speech rights. The U.S. District Court for the Western District of Kentucky ruled it unconstitutional to ban color and images in tobacco advertising. But the court upheld provisions requiring large, strongly worded warnings on tobacco packaging, prohibiting companies from making health claims about tobacco products without Food and Drug Administration review, and banning tobacco-branded events and merchandise, such as T-shirts. American Thoracic Society president Dr. J.R. Curtis said in a statement that the society is “confident that the FDA will exercise its new authority to reduce tobacco use in the U.S. by stopping the efforts of big tobacco to market its dangerous products to minors, and by giving current smokers more motivation to stop smoking.”
New York Limits Its Salt
The New York City Health Department said it will ask restaurants and producers of packaged food to voluntarily reduce sodium in their meals and products by 25% over 5 years in an effort to curb high blood pressure and heart disease. The department acted as leader of the National Salt Reduction Initiative, a partnership of cities, states, and health organizations. The New York agency said that nearly 80% of the sodium in Americans' diets is added to foods before they are sold. After a year of consultation with food industry leaders, the coalition has developed targets for salt reductions in various foods. In a statement following the New York announcement, Centers for Disease Control and Prevention director Dr. Thomas Frieden endorsed such efforts: “The majority of Americans are consuming about twice the recommended limit of sodium each day, and not by choice. Achieving substantial reductions in sodium levels by incremental decreases in sodium content across the food supply can save many lives while maintaining good taste.”
Few Drug-Safety Data Are Online
Safety and efficacy information collected as part of the federal drug approval process is not available online for 9 of the top 25 prescribed brand-name drugs in the United States, according to the Sunlight Foundation, which advocates for transparency in government. The foundation's report found that the FDA makes background documents available online only for drugs approved since 1997. Information for drugs approved earlier is online only in response to a formal request. Safety and efficacy information for Lipitor (atorvastatin), Plavix (clopidogrel), and Synthroid (levothroxine) is not available online, according to the foundation. In addition, the information that is online is in a format that's difficult for researchers and the public to use, according to the report.
FDA Okayed 26 Meds in 2009
The FDA approved 19 new chemical entities and 7 new biologic agents in 2009, according to Washington Analysis, a Washington, D.C.–based investment adviser. Among the new biologics were Medicis's injectable wrinkle fighter Dysport. In the report, Washington Analysis's Ira Loss said he had expected more approvals last year because the agency claimed it wouldn't let statutory approval dates be overridden and it received more money for reviews. In 2008, the FDA approved 21 new chemical entities and 4 new biologics, the report said.
CMS Launches Provider Survey
The Centers for Medicare and Medicaid Services kicked off its fifth annual survey to determine provider satisfaction with Medicare fee-for-service contractors. The contractors process and pay more than $370 billion in Medicare claims each year. The Medicare Contractor Provider Satisfaction Survey offers physicians and other providers a chance to say how well their contractor handles inquiries, outreach, education, claims processing, appeals, reviews, and audits. The CMS said it is sending the 2010 survey to approximately 30,000 randomly selected providers, including practitioners, suppliers, and institutions. Participants can submit their responses confidentially online or via mail, fax, or telephone, the CMS said. Results of the survey, which will take several months to complete, will be released on the CMS Web site this summer, the agency said.
Adverse Event Reporting Criticized
Little information is made public about adverse events in hospitals, even though public disclosure can help clinicians improve patient safety, according to a government report. After reviewing 8 federally approved patient safety organizations and 17 systems that collect adverse event information for states, the Department of Health and Human Services Inspector General found that only 7 state systems passed along to providers adverse event analyses that led to changes in practice. The other states passed along reports without any analysis. A nationwide database of adverse events collected by the patient safety organizations won't be operational until at least 2011, the report said.
Tobacco Act Takes a Hit
A federal district court has struck down parts of the Family Smoking Prevention and Tobacco Control Act of 2009, saying that some of the landmark law violates tobacco makers' free speech rights. The U.S. District Court for the Western District of Kentucky ruled it unconstitutional to ban color and images in tobacco advertising. But the court upheld provisions requiring large, strongly worded warnings on tobacco packaging, prohibiting companies from making health claims about tobacco products without Food and Drug Administration review, and banning tobacco-branded events and merchandise, such as T-shirts. American Thoracic Society president Dr. J.R. Curtis said in a statement that the society is “confident that the FDA will exercise its new authority to reduce tobacco use in the U.S. by stopping the efforts of big tobacco to market its dangerous products to minors, and by giving current smokers more motivation to stop smoking.”
New York Limits Its Salt
The New York City Health Department said it will ask restaurants and producers of packaged food to voluntarily reduce sodium in their meals and products by 25% over 5 years in an effort to curb high blood pressure and heart disease. The department acted as leader of the National Salt Reduction Initiative, a partnership of cities, states, and health organizations. The New York agency said that nearly 80% of the sodium in Americans' diets is added to foods before they are sold. After a year of consultation with food industry leaders, the coalition has developed targets for salt reductions in various foods. In a statement following the New York announcement, Centers for Disease Control and Prevention director Dr. Thomas Frieden endorsed such efforts: “The majority of Americans are consuming about twice the recommended limit of sodium each day, and not by choice. Achieving substantial reductions in sodium levels by incremental decreases in sodium content across the food supply can save many lives while maintaining good taste.”
Few Drug-Safety Data Are Online
Safety and efficacy information collected as part of the federal drug approval process is not available online for 9 of the top 25 prescribed brand-name drugs in the United States, according to the Sunlight Foundation, which advocates for transparency in government. The foundation's report found that the FDA makes background documents available online only for drugs approved since 1997. Information for drugs approved earlier is online only in response to a formal request. Safety and efficacy information for Lipitor (atorvastatin), Plavix (clopidogrel), and Synthroid (levothroxine) is not available online, according to the foundation. In addition, the information that is online is in a format that's difficult for researchers and the public to use, according to the report.
FDA Okayed 26 Meds in 2009
The FDA approved 19 new chemical entities and 7 new biologic agents in 2009, according to Washington Analysis, a Washington, D.C.–based investment adviser. Among the new biologics were Medicis's injectable wrinkle fighter Dysport. In the report, Washington Analysis's Ira Loss said he had expected more approvals last year because the agency claimed it wouldn't let statutory approval dates be overridden and it received more money for reviews. In 2008, the FDA approved 21 new chemical entities and 4 new biologics, the report said.
CMS Launches Provider Survey
The Centers for Medicare and Medicaid Services kicked off its fifth annual survey to determine provider satisfaction with Medicare fee-for-service contractors. The contractors process and pay more than $370 billion in Medicare claims each year. The Medicare Contractor Provider Satisfaction Survey offers physicians and other providers a chance to say how well their contractor handles inquiries, outreach, education, claims processing, appeals, reviews, and audits. The CMS said it is sending the 2010 survey to approximately 30,000 randomly selected providers, including practitioners, suppliers, and institutions. Participants can submit their responses confidentially online or via mail, fax, or telephone, the CMS said. Results of the survey, which will take several months to complete, will be released on the CMS Web site this summer, the agency said.
Adverse Event Reporting Criticized
Little information is made public about adverse events in hospitals, even though public disclosure can help clinicians improve patient safety, according to a government report. After reviewing 8 federally approved patient safety organizations and 17 systems that collect adverse event information for states, the Department of Health and Human Services Inspector General found that only 7 state systems passed along to providers adverse event analyses that led to changes in practice. The other states passed along reports without any analysis. A nationwide database of adverse events collected by the patient safety organizations won't be operational until at least 2011, the report said.
Tobacco Act Takes a Hit
A federal district court has struck down parts of the Family Smoking Prevention and Tobacco Control Act of 2009, saying that some of the landmark law violates tobacco makers' free speech rights. The U.S. District Court for the Western District of Kentucky ruled it unconstitutional to ban color and images in tobacco advertising. But the court upheld provisions requiring large, strongly worded warnings on tobacco packaging, prohibiting companies from making health claims about tobacco products without Food and Drug Administration review, and banning tobacco-branded events and merchandise, such as T-shirts. American Thoracic Society president Dr. J.R. Curtis said in a statement that the society is “confident that the FDA will exercise its new authority to reduce tobacco use in the U.S. by stopping the efforts of big tobacco to market its dangerous products to minors, and by giving current smokers more motivation to stop smoking.”
New York Limits Its Salt
The New York City Health Department said it will ask restaurants and producers of packaged food to voluntarily reduce sodium in their meals and products by 25% over 5 years in an effort to curb high blood pressure and heart disease. The department acted as leader of the National Salt Reduction Initiative, a partnership of cities, states, and health organizations. The New York agency said that nearly 80% of the sodium in Americans' diets is added to foods before they are sold. After a year of consultation with food industry leaders, the coalition has developed targets for salt reductions in various foods. In a statement following the New York announcement, Centers for Disease Control and Prevention director Dr. Thomas Frieden endorsed such efforts: “The majority of Americans are consuming about twice the recommended limit of sodium each day, and not by choice. Achieving substantial reductions in sodium levels by incremental decreases in sodium content across the food supply can save many lives while maintaining good taste.”
Few Drug-Safety Data Are Online
Safety and efficacy information collected as part of the federal drug approval process is not available online for 9 of the top 25 prescribed brand-name drugs in the United States, according to the Sunlight Foundation, which advocates for transparency in government. The foundation's report found that the FDA makes background documents available online only for drugs approved since 1997. Information for drugs approved earlier is online only in response to a formal request. Safety and efficacy information for Lipitor (atorvastatin), Plavix (clopidogrel), and Synthroid (levothroxine) is not available online, according to the foundation. In addition, the information that is online is in a format that's difficult for researchers and the public to use, according to the report.
FDA Okayed 26 Meds in 2009
The FDA approved 19 new chemical entities and 7 new biologic agents in 2009, according to Washington Analysis, a Washington, D.C.–based investment adviser. Among the new biologics were Medicis's injectable wrinkle fighter Dysport. In the report, Washington Analysis's Ira Loss said he had expected more approvals last year because the agency claimed it wouldn't let statutory approval dates be overridden and it received more money for reviews. In 2008, the FDA approved 21 new chemical entities and 4 new biologics, the report said.
CMS Launches Provider Survey
The Centers for Medicare and Medicaid Services kicked off its fifth annual survey to determine provider satisfaction with Medicare fee-for-service contractors. The contractors process and pay more than $370 billion in Medicare claims each year. The Medicare Contractor Provider Satisfaction Survey offers physicians and other providers a chance to say how well their contractor handles inquiries, outreach, education, claims processing, appeals, reviews, and audits. The CMS said it is sending the 2010 survey to approximately 30,000 randomly selected providers, including practitioners, suppliers, and institutions. Participants can submit their responses confidentially online or via mail, fax, or telephone, the CMS said. Results of the survey, which will take several months to complete, will be released on the CMS Web site this summer, the agency said.