Observers Argue About Whether FDA Found Teeth in Drug Approval Process
The New York Times reports conflicting opinions on the Food and Drug Administration’s attitude to drug approvals since Merck’s Vioxx painkiller had to be withdrawn from the market two years ago because of increased risk of cardiovascular events. On one end, some pharmaceutical manufacturers and patient advocacy groups complain about slower reviews. Only one out of 14 drugs submitted to the agency were approved on first try dyring fiscal year 2005. Some drugs approved in Europe receive “approvable” letters from the FDA which requires more information before aggreeing to sales in the U.S. 90-day delays are also more common.
On the other hand, in a recent report the Institute of Medicine funded by the FDA and other government agencies recommends that Congress puts more emphasis on post-approval safety monitoring in the FDA’s mission and powers. For now the drug industry’s user fees contribute to funding the approval process, not efficacy and safety studies once medication is used in the “real world.”
September 29, 2006 Related topics: Legal & legislative, Pharmaceuticals