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The Senate passed a bill that requires the FDA to monitor the safety of drugs more rigorously once they’re on the market, but punted on other proposals that would have allowed the legal import of drugs from other countries and bolstered the agency’s ability to regulate drug advertising aimed at consumers.
The drug-safety measures incorporate many suggestions from an Institute of Medicine report last year that critiqued FDA’s ramshackle efforts to track side effects and other problems associated with drugs such as Merck’s painkiller Vioxx once they have run the regulatory-approval gauntlet. The bill would more than double the staff assigned to the FDA office responsible for monitoring drug safety, establish a computerized registry to track drug side effects, and allow the agency the power to order new clinical trials, limit drug distribution and change drug labels if problems emerge (the FDA must now negotiate such changes with a drug’s maker). It requires drugmakers to mention safety problems clearly in their advertising and orders the federal government to establish a public database of drug-related clinical trials that should, in principle, make it easier to detect drug-safety problems in the first place.
All of these measures were wrapped together with a renewal of PDUFA — the law that authorizes the FDA to collect user fees from industry that fund roughly half of its drug-review apparatus. That law expires Sept. 30, so the reauthorization bill — considered “must pass” legislation since the FDA would have to make drastic staff and operations cuts if it lapses — has become a vehicle for a variety of reform measures. Many of them, however, fell by the wayside as the bill moved through the Senate. The bill now heads to the House, which hasn’t yet taken up its own user-fee renewal measure.
Most of these safety-related changes are long overdue, despite the uncertainty they may now create for biotechnology companies. Concerns about drug safety are real and rising — witness what Amgen is going through with its anemia franchise — and in the end it will be better for industry if a more safety-minded FDA has the hard data and fine-tuned policy tools it needs to make nuanced judgments about future safety risks. Of course, it’s almost impossible for a bill like this to pass without at least one completely symbolic measure — here, I’d nominate the doubling of fines for drug-safety violations to a piddling $2 million — not to mention unrelated constituent-service items that legislators just can’t seem to resist. (For an amusing — or horrifying — list, check out the WSJ Health Blog.)
For more on the Senate PDUFA bill, see the NYT, the WaPo, the LAT, and the WSJ.