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Washington, D.C. - U.S. Rep. Maurice D. Hinchey (D-NY) today offered the following reaction to the Institute of Medicine's (IOM) report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," a report commissioned by the Food and Drug Administration (FDA) in the wake of several drug safety scandals in 2004.
"I applaud the IOM for addressing the most serious problems plaguing the FDA. The report rightly points to the FDA's lack of stable leadership in recent years, and the detrimental effect that instability has had on the agency's mission and personnel; the failure of Congress to provide the FDA with the appropriate authority to regulate post-marketing risk assessments and enforce compliance; the undue influence that the agency's dependence on user fees gives to the agencies the FDA is tasked with regulating; and the deleterious impact of packing drug approval advisory committees with members that have clear conflicts of interest. The report also makes several solid, practical recommendations on how to balance the competing demands of rapid drug approvals and drug safety.
"However, the IOM's recommendations fall far short of the aggressive reforms needed to restore confidence in the drug approval process. The report rejects the establishment of an independent center for post-market drug safety, does not call for an end to FDA's reliance on industry user fees, and fails to demand an end to advisory committee members with conflicts of interest. I have introduced legislation, the FDA Improvement Act, which takes the most comprehensive approach to reforming the agency, ensuring that patient safety is the agency's preeminent concern, not drug company profits. Unfortunately, I fear that the report's much weaker recommendations will be seen as an endorsement of some weaker proposals circulating in Congress."
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