FDA's User-Fee Habit

All sides agree it's a historic opportunity to consider the effects of the program at a time when drug-safety issues are paramount, the long-term consumption of prescription drugs has surged and cutting-edge medications will no doubt continue to emerge.

Scott Lassman, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America, the industry's lobby group, said drugmakers would be happy to have Congress fully fund the FDA. Yet Lassman added, "That is not going to happen, so we are willing to step up."

Since user fees were put in place, the FDA has more than doubled its drug-review staff, to 2,691 as of fiscal 2006 from 1,227. The result, according to the FDA, is that 1,220 new drugs have hit the market, addressing heart problems, psychiatric disorders, cancer and cardiovascular disease, since 1992.

Drug companies and the FDA recently proposed to Congress that the industry payment for fiscal 2008 be about $393 million.

The money that would be spent would probably be directed to post-market surveillance, improved computer technology and access to medical databases. It would also fund changes in a program that requires manufacturers to report problems with drugs on the market to the FDA.

In return for the additional resources, the FDA must meet performance goals. These stipulate that 90 percent of priority drug applications be decided within six months and those for standard drugs within 10 months. Before the legislation was first approved in 1992, review could take up to 30 months.

The FDA has said it has met or exceeded those goals. The agency's efficiency doesn't impress critics.

Peter Lurie, deputy director of Public Citizen's Health Research Group in Washington, a public-interest organization that promotes medical safety, said the funding arrangement has turned the FDA's relationship with industry into a partnership.

"The agency has developed an addiction to user fees," Lurie said. "They can ask industry for a little more, and industry is willing to fork over more for more control."

Other critics referred to research recently published by Harvard University that showed the agency often needs more time to make a decision about a new drug but wraps up the review to meet its performance goal. That sometimes leads to problems after the drug is on the market, it said.

"The deadlines create real pressure not to come up with questions at the last minute," said Susan Wood, former director of the FDA Office of Women's Health. Wood resigned in 2005 over a delay in approving the over-the-counter emergency contraceptive known as Plan B. She now heads an FDA project at GWU.

Other criticisms center on a spending limitation on post-market surveillance, a provision the FDA and industry have agreed to lift.

The agency said the restriction resulted in a lack of money to monitor drugs such as Merck's Vioxx painkiller, which has been taken off the market.

A 2006 report by the Institute of Medicine of the National Academy of Sciences said the agency should focus on "a culture of safety," where drugs are evaluated during their entire life cycle and the agency has the freedom to spend the money as it sees fit.

The reauthorization legislation, which may be considered early this month by the Senate Committee on Health, Education, Labor and Pensions, will be reviewed along with a measure focusing on post-market safety. It was introduced by Sens. Edward M. Kennedy (D-Mass.) and Michael Enzi (R-Wyo.). Kennedy is chairman of the committee.

Cindy Skrzycki is a regulatory columnist for Bloomberg News. She can be reached atcskrzycki@bloomberg.net.