October 27, 2009

GAO: FDA Fails To Follow-Up On Approved Drugs

The FDA needs to be more effective in determining a drug's efficiency after being approved, according to a report issued on Monday by the Government Accountability Office.

The GAO said that the Food and Drug Administration is quick to approve drugs for the market, but fails to follow up on how well the drug is performing among patients.

The GAO classified the FDA's process as "accelerated approval" based solely on preliminary reports rather than ensuring that the drug is working for patients over time.

In order for a drug to gain FDA approval, the agency determines the drug's effectiveness. The agency's assessment "may be based on evidence showing that a drug has a positive impact on a surrogate endpoint--a laboratory measure, such as blood pressure--instead of more direct clinical evidence," said the GAO in a summary of its report.

After approval is earned, the FDA often assigns a drug sponsor to further assess its effectiveness among patients.

"Concerns have been raised about FDA's reliance on surrogate endpoints and its oversight of postmarketing studies," said the GAO.

The GAO analyzed a sample of 35 studies required by the FDA in its approval process.

"FDA approved 90 applications for drugs based on surrogate endpoints through its accelerated approval process from the creation of the process in 1992 through November 20, 2008, and about two-thirds of postmarketing studies have been closed," the GAO said.

"Because of the need to expedite approval, FDA approves drugs under this process based on surrogate endpoints which are not yet proven substitutes for clinical endpoints, but does require that drug sponsors complete postmarketing studies to confirm the drug's clinical benefit."

"Approvals based on surrogate endpoints can help to get new drugs and treatment possibilities on the market more quickly," said Iowa Senator Chuck Grassley, ranking member of the Committee on Finance.

"Once those drugs are on the market, the FDA also needs to monitor the outcomes, and this GAO report indicates that the follow-up hasn't been happening as it needs to be. The report should serve as an impetus for the FDA to improve the post-market surveillance of these drugs, giving patients and their doctors' meaningful information and necessary safeguards."


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