Abstract
THE FDA SYSTEM FOR ENSURING the safety of new drugs needs a serious overhaul, says a report from the Institute of Medicine. The system for monitoring the safety of drugs after they are marketed is hampered by a lack of clear regulatory authority, chronic underfunding, scarcity of post-approval data, and organizational problems, IOM says. The committee that wrote the report offered a broad set of recommendations to improve drug safety. For two years after approval, drugs should have a black triangle on the label indicating that the drug is new. The committee also would favor a ban on direct-to-consumer advertising for the first two years, but acknowledged that such a moratorium would be subject to legal challenges. In addition, FDA needs increased enforcement authority and better enforcement tools—including fines, injunctions, and withdrawal of drug approvals—to ensure that industry complies with label changes and conditions imposed on new products after approval. There also should be ...
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