IOM: Wide Gaps in FDA Drug-Safety Process

The U.S. Food and Drug Administration’s process for ensuring the safety of marketed drugs is taken to task in a new government report.

In its highly anticipated critique of the FDA’s drug-safety process released Friday, the Institute of Medicine said that thin funding, an ineffective organizational structure and weak enforcement muscle are all contributing to a less than optimal process to minimize the health risks of drugs the agency approves for market.

The IOM report particular zeroed in on the stage at which drugs are released into the marketplace and being prescribed in patients as an especially weak link in the drug-safety chain, noting that resources and therefore efforts to monitor medications’ risk-benefit profiles taper off after approval.

In the wake of recent safety scandals such as the recall of Merck’s painkiller Vioxx after an increased cardiac risk was seen in patients taking the drug long term and a troubling rise in suicidal behaviors in children taking prescription anti-depressants, FDA critics said the agency had a conflict in approving drugs for market then later having to second-guess its own decisions by monitoring drug safety at the post-market phase, and called for a separate body to oversee drug safety of marketed products.

IOM also found there is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry and that the two sectors do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.

To address these concerns, the report advised:

— Labeling requirements and advertising limits for new medications.

— Clarified authority and additional enforcement tools for the agency.

— Clarification of the FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits.

— Mandatory registration of clinical-trial results to facilitate public access to drug-safety information.

— An increased role for the FDA’s drug-safety staff.

— A large boost in funding and staffing for the agency.