Provisions in the fiscal year 2008 budget proposal released last week by President Bush that would increase user fees paid to FDA would "give business too much influence" over the agency, according to some critics, USA Today reports (Schmit, USA Today, 2/14). Under the 1992 Prescription Drug User Fee Act, pharmaceutical companies agreed to pay user fees in exchange for reviews of new medications in 12 months or less. Pharmaceutical companies pay user fees when they file applications for new medications based on the number of manufacturing facilities that they operate and the number of products that they market in the U.S. The law will expire this year without reauthorization by Congress (Kaiser Daily Health Policy Report, 1/12). The budget proposal would increase funds for FDA by $100 million, which includes a large increase in user fees for brand-name pharmaceutical companies and the first fees for generic pharmaceutical companies. The $2.1 billion FDA budget includes almost $444 million in user fees from industries regulated by the agency, with $15.7 million in fees from generic pharmaceutical companies (Kaiser Daily Health Policy Report, 2/6). The Bush administration maintains that the increased user fees are needed because the number of applications FDA receives has increased.

Criticism
However, House Energy and Commerce Subcommittee on Oversight and Investigations Chair Bart Stupak (D-Mich.) said that user fees have limited the ability of FDA to ensure prescription drug safety. The Pharmaceutical Research and Manufacturers of America estimates that pharmaceutical companies will fund almost 60% of the cost of FDA reviews of applications for prescription drugs in FY 2008, compared with about 40% in FY 1998. Alan Goldhammer, deputy vice president for regulatory affairs at PhRMA, said, "There's concern about it getting this high." The Biotechnology Industry Organization maintains that user fees should not fund more than half the budget for reviews of applications for prescription drugs. Rep. John Spratt (D-S.C.), chair of the House Budget Committee, said that Congress likely will reject many of the provisions related to user fees in the budget proposal (USA Today, 2/14).