Tuesday, April 24, 2007
Richard Epstein on the Kennedy FDA Bill
Commentary in the Wall Street Journal -- Risky Drug Business, by Richard Epstein. Here's an excerpt:
Sen. Edward Kennedy fired the latest shot in the battle over pharmaceutical regulation last week with the introduction of his FDA Revitalization Act. And, surprisingly, those who want to speed up the drug approval process will cheer the centerpiece of his bill: A "Sense of the Senate" that declares the Prescription Drug User Free Act (PDUFA) a success.
PDUFA, which was first adopted in 1992, uses funds from a tax on drug companies to speed up FDA internal procedures. Set to expire in September, Sen. Kennedy's support for it now is an indication that the Senate will not get hung up on the criticism that has emerged in the past -- that it turns the agency into a tool of the drug industry. PDUFA does not guarantee drug approval, which continues to be judged under regular agency rules. But on average it has shortened the unfortunate (and deadly) delays in reviewing new drug applications by six months. And it has done so without reducing the quality of the approvals.
Nonetheless, these new procedures might lead to other significant reforms. One would reward with cash, not burden with paperwork, the physicians, who report adverse incidents to the government, on the grounds that carrots get more information than sticks. Second, the FDA might let up a bit on its hostility toward allowing new drugs on the market, as evidenced by last week's resounding 20-1 decision by an FDA advisory committee to reject Merck's Arcoxia, a Cox-2 inhibitor in Vioxx's class of drugs. More than 60 other countries have already approved Arcoxia for sale. If only the FDA had stated that it would be more receptive to letting Arcoxia and other drugs onto the market once post-marketing review procedures are improved.
But neither Congress nor the FDA has mastered the fundamental lesson of risk analysis. Keeping drugs off the market deprives all informed patients the opportunity to correct FDA errors. Letting new drugs on the market leaves individual patients the option to decline their use. In the long term, Congress must wean the FDA from its misapplied "first, do no harm" principle, which causes far more harm than it prevents.