FDA Reform: Déjà Vu Encore

The Food and Drug Administration (FDA) creates the climate for the development of new drugs and clinical research. A 30 year struggle to bring drugs to the market more rapidly culminated in the 1992 Prescription Drug User Fee Act (PDUFA). While drug review times have shortened, concerns about drug safety possibly associated with more rapid reviews have led FDA and Congress to tighten safety requirements that may well slow or discourage clinical research. The pipeline for new drugs has been shrinking recently because of problems in the translation of fundamental research to pharmaceutical applications, according to the FDA. The FDA has therefore expanded its mandate to embark on a critical path initiative to develop the necessary translational tools. Critics including Congress, the General Accountability Office, the Institute of Medicine and the FDA’s own Science Advisory Subcommittee have sharply criticized the FDA’s performance, stating that the FDA’s science base is inadequate and that the FDA should have greatly increased resources to hire more scientists. After almost 50 years of concern about the FDA’s oversight of drugs, it is time to carefully review the structure and organization of the FDA and to consider creating a separate agency dedicated only to the regulation of medical products. To strengthen its scientific resources, the FDA should consider much greater use of non-government scientists and physicians as a more cost-effective way to acquire necessary expertise.