Healthy Skepticism Library item: 9961

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Editorial .
Reforming the F.D.A.
New York Times 2007 May 3
http://www.nytimes.com/2007/05/03/opinion/03thu1.html?_r=1&oref=slogin

Full text:

A bill headed for a vote in the Senate would usher in much needed reforms at the Food and Drug Administration. But it also risks making the agency even more dependent on funds from the industry it regulates.

The measure, sponsored by Senators Edward Kennedy, Democrat of Massachusetts, and Michael Enzi, Republican of Wyoming, would help rectify the agency’s most glaring weakness: an inability to crack down on dangerous prescription drugs whose adverse effects are discovered only after they have been widely used and many people have been harmed. The F.D.A. currently puts far more money and staff into approving new drugs than it does into monitoring them after they are on the market, and it lacks the legal authority to do much about hazards discovered at that stage.

So it is salutary that the new bill would pump more money into postmarketing regulation and push the agency into a more active role in searching vast databases for adverse drug effects. For the first time, the agency would be given the power to require postmarketing studies, and it could fine companies that refused to comply.

These and other improvements, however, would come at a stiff price: an ever greater reliance on the user fees paid by the companies. The fees were first imposed in 1992 so the agency could hire additional staff members to speed up the approval process and reduce a backlog of applications. In that respect, they were a rousing success. But over the years the fees have increased at a faster rate than appropriations. Today industry pays more than half of the cost of the agency’s drug reviews. And the new bill would set the fees on a trajectory that could reach 70 percent in coming years.

This is a dangerous dependency for an agency that regulates such a critical part of the nation’s health care system. It’s as if the nuclear utilities paid for oversight by the Nuclear Regulatory Commission. The potential for abuse in a such a chummy atmosphere is clearly there.

Industry representatives have enormous say in confidential meetings over how high the fees will be and what activities they will support. The tight deadlines for agency action set by the user fee law have sucked money and staff from important research and training. One recent study found that drugs approved in a rush to meet deadlines subsequently encountered more safety problems than drugs approved with less deadline pressure.

Unfortunately, the fees have become such a big part of the overall F.D.A. budget – roughly 20 percent of the total – that it would be difficult to eliminate them without making budget deficits worse. Perhaps the best course would be to reauthorize the fees for two years, not the five written into the current Senate bill. The F.D.A., the White House and Congress should then use the time to figure out a way to wean the F.D.A. from its risky dependency.