GAO Pushes FDA to Improve Drug Oversight

A recent report from the Government Accountability Office (GAO) suggested that the FDA has permitted certain drugs to remain on the market even when follow-up studies showed that the treatment did not extend patients' lives. In addition, according to the GAO report, the FDA has never pulled a drug from the market because of a lack of mandatory follow-up data regarding its benefits.

Typically, the FDA would rather the clinical trials demonstrate the effectiveness of a new drug by showing its impact on a clinical end point-a direct measure of how a patient feels, functions, or survives. Showing this, however, can take many years and hundreds of millions of dollars for the manufacturer. Alternatively, a drug maker may submit an application based on a drug's impact on a surrogate end point--a laboratory measure that suggests that the drug will make real improvements in patient health.

These measures can be used in an accelerated or traditional approval process and are designed to expedite the approval of applications for certain new drugs that are designed to treat serious or life-threatening illnesses (eg, drugs to treat cancer, HIV/AIDS, and inhalation anthrax) and that are expected to provide a meaningful therapeutic benefit over existing therapy. Drug makers must then conduct postmarketing studies to prove that the drug is doing what it promised.

Although the FDA requires additional studies once the drug is on the market, only 64% of the 144 studies that have been required under the program since 1992 have been completed-leaving over one third still pending. Although the FDA is improving its process, congressional investigators claim that the agency does not adequately track drugs that were approved using surrogate end points. The FDA said in response that it would be "difficult, if not impossible" to write a standard policy for withdrawals, given the unique nature of individual drugs; and in some cases, withdrawal from the market would remove the condition's only available treatment.

The GAO recommends that the FDA make clear the conditions under which it would remove drugs from the market. The GAO feels that this measure would improve the FDA's oversight.

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