FDA's User-Fee Habit
For the past 15 years, pharmaceutical companies have poured $2 billion into a program that helps finance the U.S. Food and Drug Administration, allowing the FDA to become one of the world's fastest drug-approval agencies.
That influx of money from the industry is under fire, however, from public-interest groups, academics and former FDA officials. They want to sever, or at least cut back, the financial connection between the agency and drug companies.
The current five-year Prescription Drug User Fee program expires at the end of September. It is up to Congress to reauthorize the program or risk the loss next year of about $400 million in industry funding for the FDA.
The program "served a useful purpose 15 years ago, but now it is part of the drug-safety problem rather than part of the solution," said David Michaels, director of the Project on Scientific Knowledge and Public Policy at the George Washington University School of Public Health and Health Services in the District.
The legislation was passed in 1992 to fix serious problems at the FDA: The United States lagged behind other countries in new drug therapies, especially for diseases such as AIDS, and the drug-review process was beset by chronic understaffing and delays. The FDA said some reviewers didn't even have computers.
The user-fee program has been reauthorized twice since then. As it now works, the industry and FDA negotiate the terms of the agreement, hold a hearing, get public comment and then submit a proposal to Congress for approval.
Industry fees pay for more than half the drug-review program, with funds appropriated by Congress making up the rest. In fiscal 2006, Congress appropriated $219 million for the program, and user fees came in at $304 million.
In a March 14 letter, academics and former FDA officials wrote the heads of the two committees in Congress that will consider reauthorizing the law. They said user fees compromise safety and give the perception "that industry has become the primary client of FDA rather than the American people."
The group supports direct congressional appropriations to fund the agency "to assure FDA's independence and commitment to drug safety."
Industry, congressional insiders and top officials at the FDA said that approach is politically unfeasible and would be harmful to the agency.
Over the years, the Prescription Drug User Fee Act programs "have resulted in significant public health gains by making safe and effective, yet increasingly complex, medications available to patients faster than was previously possible," said FDA Commissioner Andrew C. von Eschenbach in a statement. "User fees have allowed FDA to become more modern and to build on its reputation as the world's leading drug-regulatory agency."
FDA officials declined to be interviewed on the issue.