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Criticism of FDA Mounting

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In a blistering editorial entitled “Sidelining Safety” in the New England Journal of Medicine, the Food and Drug Administration was criticized for failure to implement the necessary to ensure patient safety. In September of 2006, sparked in part by the regulatory fallout from the withdrawal of Vioxx, the Institute of Medicine published a report entitled “The Future of Drug Safety.” This comprehensive report made a number of recommendations to the FDA and Congress on how to improve the effectiveness of drug safety regulation. Congress was urged to provide the FDA with greater legal authority and the funding necessary to fulfill its obligations.

Most of the Institute’s other recommendations were directed to the FDA. The editorial noted:

In general, the IOM urged the FDA to “embrace a culture of safety” by increasing the priority accorded to the safety of patients. Such an emphasis could have ramifications for medical care that would be as broad and positive as those that the 1999 IOM report on medical error . . . has had for the health care system. Sadly, the FDA’s official response falls far short of what the American public expects and deserves. Indeed, it highlights the very reason that the agency – with which I have had some firsthand experience – is in need of monumental change: its philosophy is no longer aligned with its regulatory mandate.

In short, the FDA is no longer working to protect us and has instead bowed to political and industry pressures to approve drugs too quickly. These problems stem from a number of issues, including the past prohibition (and current limitations) on using fees paid by drug companies for reviews of new drugs for safety monitoring once those drugs are on the market. Problems also persist due to the structure of the FDA and the fact that FDA employees with the greatest insight into safety and scientific issues have been marginalized in the drug approval process. Ultimately, the editorial questions whether the FDA has the insight necessary to be able to admit its mistakes and implement meaningful change. “Apparently, the agency’s leadership has yet to realize that the adoption of [a culture of safety] would benefit all stakeholders – industry, the community of scientists, and most important, the American public.”

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.