A Touch of Hope

Opinion Editorial - The New York Times
A Cleaner Food and Drug Agency

Published: March 23, 2007
In our highly medicated, high-technology society, it is essential that the Food and Drug Administration regulates drugs, medical devices and other products with complete objectivity — free from the taint of industry influence. So it is encouraging that the agency has proposed new rules to exclude experts who have significant financial ties to regulated industries from serving on committees that recommend whether a product should be approved.

The proposed rules may still need to be strengthened after they are critiqued during a required comment period. But even in their current form they look like a big, and long needed, improvement over the agency’s previously lax efforts to screen out conflicts of interest. The pharmaceutical industry, in particular, doles out lots of money to doctors and academic experts in the form of speaking fees, consultancies, research grants and other financial benefits. And many of these recipients end up on federal advisory committees.

All too often consumer interests are shortchanged. In one egregious example, a panel that favored marketing the controversial painkillers Bextra and Vioxx would have made the opposite recommendation if the experts with industry ties had been excluded from voting.

The new rules would bar from an advisory committee anyone whose financial interests in a company with a product up for review — or its competitors — exceed $50,000, whether in stock ownership, consulting arrangements or individual research grants. Those with smaller financial interests could participate in discussions but would not be allowed to vote. Only those with no potential conflicts could participate as full, voting members. The food and drug commissioner could still grant waivers, but officials expect them to be rare.

Some patient advocates believe the $50,000 exclusion is too generous, and the agency needs to explain more fully how it decided that was the proper cutoff point. It also needs to address whether nonvoting experts — those with smaller financial ties — might still unduly sway a committee’s decision.

Congress needs to confront another worrisome source of industry’s influence: the $300 million in annual fees paid by pharmaceutical manufacturers that help finance the approval process and regulation of drugs. Critics have long complained that these user fees distort the agency’s objectivity and make for a too cozy atmosphere between the industry and its regulators.

The Bush administration, unfortunately, is seeking to increase reliance on user fees. That’s the wrong direction to go. To ensure that the public’s interests are its only concern, the F.D.A. should be supported entirely by public funds.