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IOM Calls for FDA To Scale Up Post-Approval Monitoring of Rx Drugs

FDA should better monitor the safety of prescription drugs after they are approved and on the market, according to an Institute of Medicine report released on Tuesday, Reuters reports.

FDA currently checks for safety issues with new drugs after they have been on the market for 18 months or used by 10,000 individuals, whichever comes later. It uses reports submitted by drugmakers, physicians and patients to track a drug's side effects. However, FDA's safety tracking has been criticized heavily, particularly after the painkiller Vioxx was removed from the market five years after approval because of a link to heart attacks and strokes.

A 2007 law provided FDA with greater authority to require that drug manufacturers conduct additional post-approval safety trials or alter their labels to account for new data, rather than relying on voluntary action from the companies (Yukhananov, Reuters, 5/1). However, the report said the agency required "guidance on how best to use this new power" (Fox, National Journal, 5/1).

In the report, IOM calls for FDA to take a "life cycle" approach to drug safety oversight, conducting safety trials both before and after a drug is approved. The report also recommends that FDA:

  • Maintain a single, comprehensive and publicly available record on safety concerns and regulatory alerts for each drug;
  • Require post-approval research on drugs whose "benefits or risks are particularly uncertain" (Viebeck, "Healthwatch," The Hill, 5/1);
  • Keep and annually update a list of criteria that are allowed for use in approving new drugs; and
  • Revisit safety recommendations that were controversial or particularly difficult (Ethridge, CQ HealthBeat, 5/1).

FDA Agrees With Recommendations, Expresses Doubt About Implementation

FDA officials agreed with the recommendations, which are non-binding, but the agency expressed concerns about whether it has adequate resources to implement them.

FDA spokesperson Sandy Walsh said, "We support the general concept of enabling the public to be able to clearly monitor relevant safety issues for all drugs," adding, "However, we feel it would be very challenging to implement this recommendation within our current resources without seriously compromising other critical regulatory activities" (Reuters, 5/1).

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