Editorial: Prescribing a tougher FDA
Published May 15, 2007
When the U.S. Food and Drug Administration made news in recent years, it was usually for its incompetence. In particular, the agency's deficiencies in providing timely protection from dangerous prescription drugs was exposed by the Vioxx scandal. That reputation could be changing, thanks to a bill recently passed by the Senate that would give the FDA more authority to identify dangerous drugs and get them off the market sooner.
The Vioxx case exposed the FDA's inability to act decisively even when lives are at stake. Although the FDA learned as early as 2000 that patients taking Vioxx increased their risk of heart attack, the product wasn't withdrawn from the market for four more years - and then only because its maker, Merck, chose to do so. Meanwhile, millions of Americans were exposed to the risks and thousands undoubtedly suffered heart damage or death.
The Senate bill, though not perfect, would strengthen the FDA's authority in key areas. The agency would:
- Track drugs long beyond their initial approval for adverse effects.
- Order, rather than ask, drug manufacturers to change labels or conduct more testing of their products.
- Establish a public database of clinical trials, so that drug companies couldn't hide safety concerns.
- Double its fines of violators to a maximum $2-million.
- Provide financial incentives for manufacturers to study a drug's effects on children, not just adults.
- Require drug advertisements to describe risks in a "clear" and "neutral" manner.
Unfortunately, some important fixes were left out of the bill. It doesn't speed up the availability of generic versions of expensive biological drugs often used in cancer treatment. The Senate vows to do that separately, but it remains to be seen if lawmakers will stand up to the pharmaceutical industry on that one. Senators also rejected an attempt to legalize imported drugs from Canada, which are often much cheaper than the same drugs sold here.
While the pharmaceutical industry got some of what it wanted, senators finally got fed up with inaction. Overall, this bill should begin to give the FDA the regulatory clout it needs to protect Americans from an industry that too often lets greed override good judgment. It is important now that the House not weaken the bill further and that President Bush not let his ambivalence toward regulation get in the way.
There will be no excuse for the next Vioxx-like tragedy.