An Rx for FDA reform
YESTERDAY'S HEARING in Washington on the diabetes drug Avandia and its links to heart attacks underscores the need for a reformed Food and Drug Administration -- one that is more committed to protecting patients than to being part of the profit pipeline of the pharmaceutical industry. Avandia is just the latest example of an FDA-approved drug or medical device that has been shown to cause serious adverse effects once on the market. In 2004, Merck had to withdraw its blockbuster arthritis drug Vioxx after studies indicated it was associated with heart attacks and strokes
These FDA failures are putting Congress to the test. It is working on bipartisan legislation that has the potential to make the FDA a more effective watchdog, especially if House and Senate conference committee members agree on a final bill with provisions that break from the agency's recent track record of rushing approval for suspect medications.
A weak link in the FDA approval process has been the expert advisory committees that often include members with financial interests in the company whose drug is under review. Committee members with direct links to a company are supposed to recuse themselves from consideration of its drug, but the FDA has been allowed to grant exemptions. When a committee approved Vioxx in 1999, four of its six members had been granted waivers from the conflict-of-interest rule.
The House version of the FDA reform bill would require that no more than one member of a committee could get such a waiver. An attempt to include such a limit in the Senate bill failed narrowly.
Since 1992, the drug industry has paid hundreds of millions of dollars in annual user fees to help speed approval of new drugs. Too little money has been available for post-market safety review to track and correct problems with new medications. Both bills call for $225 million in new money from the pharmaceutical industry for such reviews.
Unfortunately, neither bill insists on the two-year moratorium on direct-to-consumer advertising for new drugs that the National Academy of Sciences' Institute of Medicine and the American Medical Association have recommended. Some adverse reactions become evident only after a new drug hits the market, and a moratorium on ads would dampen use during that initial period.
The broader problem of the FDA that reform legislation does not address is the enormous gap between its mission -- ensuring the safety of drugs, medical devices, and most of the nation's domestic and imported food -- and its annual budget of less than $2 billion. Still, a reform bill that adopts the House rule on conflict-of-interest waivers will provide some assurance that Congress can put the public interest ahead of industry's. 