The FDA: Where Do We Go From Here?

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By Jeff Hall, Executive Editor

    How bad have things gotten at the Food and Drug Administration (FDA)? When you consider some of the recent reports and developments over the past few months, it is clear that the FDA has significant credibility issues.

    In June, a report by U.S. Rep. Henry A. Waxman revealed some eye-opening trends in FDA enforcement actions in recent years. According to the report, which reportedly involved an investigation and review of copious internal agency enforcement documentation, there was a greater than 50 percent decrease from 2000 to 2005 in the number of FDA warning letters issued for violations of federal requirements.

    In July, the Union of Concerned Scientists released the results of a survey in which 61 percent of nearly 1,000 FDA scientists polled had knowledge of cases in which Department of Human and Health Services or FDA political appointees “inappropriately injected themselves into FDA determinations or actions.” Eighty-one percent agreed that the “independence and authority of the FDA post-market safety systems” need to be strengthened.

    In September, the Institute of Medicine released its assessment of the U.S. Drug Safety System. It noted that the Prescription Drug User Fee Act (see “Ethics And The FDA: Is it Time For A ‘Priority’ Review?” in the April 2005 issue of Podiatry Today) is “excessively oriented toward supporting speed of (drug) approval and insufficiently attentive to safety.”

    The institute emphasized 25 key recommendations to bolster the pre- and post-approval processes of the FDA. Among the recommendations are calls for increased enforcement authority and tools; increased financial resources but less dependence upon the Prescription Drug User Fees; improved leadership with a six-year term for the FDA Commissioner; and improved communication with the public about FDA processes for approval of new medications.

    In the wake of the Democrats regaining control of the House of Representatives and the Senate, perhaps this alleged sense of bipartisanship may be taking hold. A recently introduced bill, “The Enhancing Drug Safety And Innovation Act,” co-sponsored by Sen. Mike Enzi and Sen. Edward Kennedy, aims to address some of the reported shortcomings of the FDA. The bill reportedly seeks to:

    • establish risk evaluation and mitigation strategies (REMS) for new drugs or new indications for existing drugs that would involve more of a timetable for periodic assessment of REMS, FDA approval of professional labeling, and a surveillance plan to assess known and unknown risks;

    • establish a Reagan-Udall Institute for Applied Biomedical Research, a public-private partnership that would improve processes to develop new medications and medical devices, and evaluate their safety and efficacy;

    • establish a clinical trials database that would facilitate patient enrollment and make public the results of all Phase III and Phase IV trials; and

    • better define conflict of interest policies for FDA advisory committee members.

    As this issue went to press, Enzi planned to hear testimony in a Senate Health, Education, Labor and Pensions Committee hearing on ways to improve drug safety processes. Hopefully, our representatives in Congress will maintain this momentum for changes at the FDA. Prior to passing an agriculture appropriations bill in May, the House of Representatives yanked a provision that would have enabled the FDA to require post-market studies of newly approved prescription medications.

    While some express concerns that more regimented processes at the FDA may slow the approval of new drugs that could benefit patients, it is clear that undue influence and a lack of appropriate funding and enforcement authority have compromised the reputation of the FDA and its ability to preserve public health and safety.

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