The Institute of Medicine has recommended steps that Food and Drug Administration officials should take to determine the need for additional clinical trials on already-approved drugs when there are questions about safety.
IOM offers post-market testing guidelines
The report, “Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report,” also addresses study-design considerations that the agency should address when requiring companies to execute additional clinical trials.
Among the recommended measures are that the FDA should only require additional clinical trials when existing evidence and new observational studies aren't sufficient enough to allow officials to make a responsible policy decision; make sure that trials are appropriately designed to minimize patient risk and resolve questions about a drug's safety and efficacy; and ensure that patients are promptly informed of new findings that might affect their willingness to continue participating in the trial.
IOM officials said the letter report was issued in response to advisory questions posed by the FDA in advance of a meeting it will hold July 13-14 to discuss the diabetes drug Avandia, which has been linked to potential heart ailments. The IOM also said it will issue a more detailed analysis of post-market study ethics in a final report to be released in spring 2011.
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