IOM takes FDA to task on post-marketing safety

The FDA doesn't do enough to track drugs' safety after they're on the market, government watchdogs at the Institute of Medicine say. To prevent another Vioxx-esque disaster, FDA should periodically review marketed drugs for safety issues, an IOM report says, and require more post-marketing studies on drugs with "benefits or risks [that are] particularly uncertain." Plus, the agency needs to do a better job of presenting safety information to consumers.

"It's impossible to know all the risks and benefits of a drug before approval," IOM committee co-chair Ruth Faden told Reuters. So, the agency needs to change its policy, which requires safety checks after a drug has been on the market 18 months or used in 10,000 patients--and relies on voluntary adverse-event reports from companies, doctors and patients.

Almost as if it was anticipating the IOM's conclusion, FDA officials only recently announced that they were putting as much work and money into post-approval safety as pre-approval screenings. As Reuters points out, the agency cited orders for 385 post-marketing safety studies and 65 label changes since 2008.

Still, it's worth noting that the FDA has had its problems with enforcing its orders for post-marketing studies, and some drugmakers have been notoriously slow in following up on those commitments.

Now that the report has appeared, an FDA spokeswoman said that the agency supports "the general concept" of helping the public monitor safety issues. "However, we feel it would be very challenging to implement this recommendation within our current resources without seriously compromising other critical regulatory activities," the spokeswoman said.

- get the story from Reuters
- see the coverage from The Hill

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