Law Commons^™

Drug User Fees, Health Priorities, Politics, The Deficit And Reform Directions, Margaret Gilhooley

Margaret Gilhooley

The Food and Drug Administration now depends on user fees paid by drug companies to support more than half the salaries of the medical reviewers who advise the agency on the appropriateness of approving the drug. The funding creates a substantial risk of "capture" of the agency by the industry. Under the program,which started in 1992, drug companies pay a fee that permits the agency to hire additional reviewers to make more timely reviews on whether a drug can be approved. Under the law the agency seeks to meet performance goals for the timing of reviews, giving the program the …