IOM Urges FDA To Boost Post-Approval Rx Drug Monitoring


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 (Yukhananov, Reuters, 5/1).


FDA currently conducts post-approval monitoring of prescription drug safety in various ways, such as by using IT initiatives like the Sentinel drug tracking system.

In 2008, FDA launched the Sentinel electronic surveillance network to help identify safety issues with drugs and medical devices already on the market. The system monitors information on side effects from various databases, rather than relying on voluntary reports from companies and patients (iHealthBeat, 4/23).

Key Findings

In the report, IOM noted that advances in health IT and analytics "likely will mean that observational approaches using large data sets will become more important over time" (Lee, Modern Healthcare, 5/1). 

The report called for FDA to take a "life-cycle" approach to drug safety oversight by conducting safety trials both before and after drug approval. In addition, IOM recommended 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's Response

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

FDA spokesperson Sandy Walsh said, "We feel it would be very challenging to implement this recommendation [to adopt a life-cycle approach] within our current resources without seriously compromising other critical regulatory activities" (Reuters, 5/1).

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