Most Important Drug-Safety Legislation in a Century?

The New England Journal of Medicine in an editorial this morning calls the Food and Drug Administration bill now moving through Congress "the most important drug-safety legislation in a century." More important than the 1938 law that ushered in the safety requirement? More important than the 1962 law that required drugs be effective?

The editorial's list of the essential ingredients that must be included in a successful reform bill also did not justify the hyperbole:

While it called for mandatory public registration of clinical trials, it did not call for mandatory public posting of their results.

While it called for stiff penalties for false advertising, it did not call for a ban on direct-to-consumer ads, which are deeply resented by most members of the medical profession not to mention a significant contributor to the distortion of medical priorities in this country.

The editorial makes no mention of tougher standards for approving and monitoring medical devices. Remember the brouhaha over drug-coated stents? Millions of Americans with heart disease had them inserted, but sales are now collapsing because outcomes are worse than patients who received the bare-metal variety. Yet the provisions on devices in this bill are so weak that the industry's trade association has admitted they "dodged a bullet" and offered warm support for the bill.

And, finally, the editorial did not mention ending or even limiting conflicts of interest on FDA advisory committees, which is contained in the House version of the bill.

While the editorial refers favorably to last year's Institute of Medicine report, it ignores one of the central messages of that report: that the FDA's culture has become warped in favor of industry because of its reliance on industry user fees, in place since passage of the 1992 Prescription Drug User Fee Act. The agency is now primarily oriented toward approving new drugs, not protecting the public from unsafe or ineffective drugs.

Instead of altering those incentives, this bill increases the agency's reliance on user fees. More will go to safety compliance, for sure. But a truly significant FDA reform bill would have cut the ties between the user fees and agency performance goals, which all involve speeding new drugs to market. Or, it would have eliminated user fees entirely and appropriated taxpayer resources to fund this critical agency. Can't the government find another half billion dollars a year? Heck, that's what we spend in Iraq in two days.

The greatest reform in a century? This editorial sends a clear message to Capitol Hill on the eve of its conference committee that as far as the medical profession is concerned, milquetoast reforms are enough.

Posted by gooznews at July 19, 2007 08:03 AM