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This year, Congress had to consider reauthorization of the Prescription Drug User Fee Act (PDUFA), which it must do every 5 years. Under PDUFA, the major funding for the review of new drugs by the Food and Drug Administration (FDA) comes from user fees paid by pharmaceutical companies. This mechanism has been controversial because, although it was designed to accelerate the drug-approval process and can make new drugs available to patients without delay, it has directed no money to the postmarketing assessment of drug safety. In addition, some believe that user fees pose a conflict of interest for the FDA. Nonetheless, to ensure that the FDA has adequate financial resources, both the House and the Senate versions of the bill not only maintain these user fees but increase them (with some of the money now directed to safety assessment).
In reauthorizing PDUFA, Congress has wisely taken the opportunity to strengthen the FDA's authority over drug safety, and both versions of the bill give the FDA new tools to accomplish this objective. At a minimum, we believe that the final bill should contain the following essential components.
The FDA must have the authority to mandate adequately powered postmarketing clinical trials of the safety of approved drugs and to require specific timetables for their completion and reporting of results.
The FDA must also have the authority to conduct an annual review of drug safety for the first 3 years after a drug's approval and again at 7 years.
To assist patients in reporting adverse effects of the drugs they are taking, drug advertisements and labels must include a toll-free telephone number and a Web address.
There must be substantial penalties for drug advertising that overstates efficacy or understates adverse effects.
The FDA must be able to mandate changes to drug labels as new information about safety and efficacy becomes available.
In order to provide safety surveillance, every new drug should have a pharmacovigilance plan at the time of its approval. Sophisticated pharmacoepidemiologic surveillance systems must be created to allow the FDA to monitor reports of adverse drug effects in large databases.
Clinical trials of drugs must be registered in a public database.
In the wake of the landmark report on drug safety issued by the Institute of Medicine almost a year ago,3 Congress is now poised to pass the most important drug-safety legislation in a century. Although we remain concerned about the user-fee approach to funding of the FDA, we believe that the bills initiated by Congressmen Henry Waxman and Edward Markey and by Senators Edward Kennedy and Michael Enzi are important steps in the right direction. Congress should now speedily agree on a substantive drug-safety bill and give the FDA the tools it needs to do its work. The crisis of confidence in the nation's drug supply must be resolved.
Source Information
This article (10.1056/NEJMe078154) was published at www.nejm.org on July 18, 2007.
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