Proposals take steps in the right direction

The arthritis painkiller Vioxx leads a rogues’ gallery of drugs that have made it to market without sufficient testing, causing cardiovascular problems long after alarm bells began to go off. It is one dramatic example of how the Food and Drug Administration has failed in its mission. It approves too many drugs and medical devices without a close enough review, and then acts too slowly when evidence mounts of problems with new drugs or devices after they are in the market.

Ever since Merck had to pull Vioxx off the market in 2004, Congress, the Institute of Medicine of the National Academy of Science, and the FDA itself have all explored ways to give drug safety a higher priority. Now a proposal by the FDA would ensure more objective pre-approval review, and Congress has a plan to steer more money into post-market scrutiny of new products.

Last month, the FDA proposed to do a better job of preventing physicians who have a substantial financial interest in a company introducing a new drug or device from serving on the committees that make advisory recommendations on such products. Any doctor with a stake of $50,000 or more in a company backing a new drug (or in one of the company’s competitors) would be disqualified from serving on an FDA advisory committee. Doctors whose stake is less than $50,000 could participate in panel discussions but not vote.

Currently, advisory panel members can have up to a $100,000 tie to a company, as long as waivers are granted, as they often are. The new proposal would permit waivers only by the FDA commissioner himself.

Post-market safety surveillance by the FDA has been inadequate because agency funding – much of it from user fees paid by the drug industry itself – has gone disproportionately to speed the approval of new drugs. Bills proposed by Sen. Edward Kennedy and Massachusetts Rep. Edward Markey would increase funding for safety review.

Both measures would also adopt the recommendation in a report by the Institute of Medicine last year that drug companies be forbidden to advertise new drugs directly to consumers for a period of time after approval. The no-ads period would be two years in the Kennedy bill, three years in Markey’s.

The FDA needs to find a balance between expeditious approval of drugs or devices that hold the promise to cure diseases or alleviate debilitating conditions on the one hand, and the kind of rigorous scrutiny that will uncover – preferably before approval – the dangerous side effects of many new medications. Reducing conflicts of interest among the agency’s advisers and boosting its budget for post-approval safety reviews are sensible ways to pursue that equilibrium.



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