Renewal sought for drug approval user fee law

Some observers are urging Congress to seek a proper balance between federal and drug company funding of the FDA.

By Susan J. Landers, AMNews staff. May 7, 2007.

Washington -- A growing chorus of former FDA commissioners, medical journal editors, researchers, clinicians and consumer groups are voicing concern about the reauthorization of a 15-year-old law that allows pharmaceutical companies to contribute a large portion of the Food and Drug Administration's drug approval budget in exchange for quick review of their products.

Their message is that agency funds should come solely from federal coffers and not in the form of user fees from the same industry the FDA regulates. These experts are urging Congress via letters and journal articles to eliminate the Prescription Drug User Fee Act or substantially alter it.

The user fee, they charge, is a funding mechanism that threatens the integrity of the drug approval system and even could affect the agency's already shaky safety procedures by pushing for fast approval of possibly dangerous drugs.

But Congress is intent upon reaffirming the measure, calling it a "must-do piece of legislation," according to a spokesman for Sen. Mike Enzi (R, Wyo.), ranking member of the Senate Health, Education, Labor and Pensions Committee. It is currently being considered as part of a larger bill . Without congressional action, the law will expire Sept. 30.

PDUFA supporters -- who include the FDA commissioner and pharmaceutical companies --contend that the fees paid by the firms are as necessary now as they were when the law was first enacted in 1992 to help speed drug approvals. They would like to hang onto those funds, which would amount to nearly $400 million next year, $87 million more than last year when the fees accounted for about 40% of the FDA's total human drug program.