U.S. panel wants to scrutinize FDA safety actions
I read the below article and can't decide which amongthe following are more accurate.
* The FDA is trying to get the word out that they don't have enough clout to stop big drug companies from forcing approvals for their products.
* The reviews and recommendations are part of a normal, ongoing process but makes for good copy.
* Some reviewers of FDA processes are skeptical that any recommendations are ever taken seriously by the FDA which is failing to protect the consumer.
* Manufacturers of recently FDA-recalled drugs are attempting to pass blame onto the FDA for allowing their own unsafe drugs on the market in the first place.
But, that's why this is a great article, we can support any of these as the overriding conclusion.
dras
REUTERS 5/19/05 U.S. panel wants to scrutinize FDA safety actions By Lisa Richwine Members of a U.S. advisory panel told the Food andDrug Administration on Thursday they want to review how the agency handled drug recalls and serious safetyissues. The panel voted unanimously in favor of having the agency provide it with details on its actions leading up to drug withdrawal so that the advisers could help identify areas for improvement.
"I think it would be really helpful to have a transparent look back at where we think things could have been better," said panel member Arthur Levin, director of the Center for Medical Consumers. "It's always good to learn from mistakes. The FDA's drug-safety monitoring has come under scrutiny following the recent emergence of serious side effects of some medicines and the recalls of Merck & Co. Inc.'s Vioxx and Pfizer Inc.'s Bextra painkillers. The FDA will consider the panel's suggestion, saidAnne Trontell, deputy director of the agency's Office of Drug Safety. But she stressed that officials already were actively looking at ways to improve safety surveillance."It's already an area of active interest," she said. For example, the FDA has asked the Institute of Medicine to review its post-approval reviews of drug safety, she said. The agency also set up a board to evaluate emerging safety issues.The focus of the panel that met Thursday is to advisethe FDA on drug safety and management of risks from medicines. The panel is one of several committees of outside experts that provide non-binding recommendations to the FDA. Some panel members suggested the FDA needed more power to compel drug companies to complete studies after approval so regulators can learn about potential problems sooner. Now, the agency can only request the studies in most cases.Dr. Curt Furberg, a panelist and an epidemiologist at Wake Forest University, said was unsure if the FDAwould take the panel's advice."The feeling is our advice will go into a black boxand we don't know what will happen next. We should find a mechanism so that we can be involved in next step," he said.Vioxx was pulled from the market in September 2004 after a study linked the drug to elevated risks of heart attacks and strokes when taken for at least 18 months. Some critics said the FDA should have taken earlier signals of a problem more seriously. The FDA asked Pfizer to withdraw Bextra last month, saying the drug was too risky because it can cause rare but serious skin reactions and also has potential heart risk.
* The FDA is trying to get the word out that they don't have enough clout to stop big drug companies from forcing approvals for their products.
* The reviews and recommendations are part of a normal, ongoing process but makes for good copy.
* Some reviewers of FDA processes are skeptical that any recommendations are ever taken seriously by the FDA which is failing to protect the consumer.
* Manufacturers of recently FDA-recalled drugs are attempting to pass blame onto the FDA for allowing their own unsafe drugs on the market in the first place.
But, that's why this is a great article, we can support any of these as the overriding conclusion.
dras
REUTERS 5/19/05 U.S. panel wants to scrutinize FDA safety actions By Lisa Richwine Members of a U.S. advisory panel told the Food andDrug Administration on Thursday they want to review how the agency handled drug recalls and serious safetyissues. The panel voted unanimously in favor of having the agency provide it with details on its actions leading up to drug withdrawal so that the advisers could help identify areas for improvement.
"I think it would be really helpful to have a transparent look back at where we think things could have been better," said panel member Arthur Levin, director of the Center for Medical Consumers. "It's always good to learn from mistakes. The FDA's drug-safety monitoring has come under scrutiny following the recent emergence of serious side effects of some medicines and the recalls of Merck & Co. Inc.'s Vioxx and Pfizer Inc.'s Bextra painkillers. The FDA will consider the panel's suggestion, saidAnne Trontell, deputy director of the agency's Office of Drug Safety. But she stressed that officials already were actively looking at ways to improve safety surveillance."It's already an area of active interest," she said. For example, the FDA has asked the Institute of Medicine to review its post-approval reviews of drug safety, she said. The agency also set up a board to evaluate emerging safety issues.The focus of the panel that met Thursday is to advisethe FDA on drug safety and management of risks from medicines. The panel is one of several committees of outside experts that provide non-binding recommendations to the FDA. Some panel members suggested the FDA needed more power to compel drug companies to complete studies after approval so regulators can learn about potential problems sooner. Now, the agency can only request the studies in most cases.Dr. Curt Furberg, a panelist and an epidemiologist at Wake Forest University, said was unsure if the FDAwould take the panel's advice."The feeling is our advice will go into a black boxand we don't know what will happen next. We should find a mechanism so that we can be involved in next step," he said.Vioxx was pulled from the market in September 2004 after a study linked the drug to elevated risks of heart attacks and strokes when taken for at least 18 months. Some critics said the FDA should have taken earlier signals of a problem more seriously. The FDA asked Pfizer to withdraw Bextra last month, saying the drug was too risky because it can cause rare but serious skin reactions and also has potential heart risk.
posted by nawledge at
10:58 PM
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