GAO Report Backs Link Between Drug User Fees and Higher Rate of Drug Withdrawals

Sept. 25, 2002

GAO Report Backs Link Between Drug User Fees and Higher Rate of Drug Withdrawals

Statement of Peter Lurie, Deputy Director of Public Citizen’s Health Research Group

A new government report shows that since the Prescription Drug User Fee Act (PDUFA) was implemented in 1992, a higher percentage of newly approved drugs has been withdrawn because the drugs were found to be unsafe. These findings echo criticisms we have had of the act for years. In 1998, Public Citizen conducted a survey of the physicians who review New Drug Applications and found that the reviewing physicians had opposed the approval of 27 drugs approved in the previous three years. The General Accounting Office’s (GAO) conclusions confirm the major public health consequences of PDUFA, which introduced private money, and therefore influence, into the drug approval process, creating a massive conflict of interest. One result of PDUFA has been the diversion of agency funds to the review process from other areas, including postmarketing safety surveillance.

The GAO report also documents that staff turnover is higher among Food and Drug Administration (FDA) scientists than among scientists in other government agencies. Our 1998 report documented how physicians were precluded from presenting data adverse to the drugs they were reviewing at FDA Advisory Committee meetings.

Unwise drug approvals by the FDA, in part because of increased workloads due to PDUFA, have led to unnecessary patient deaths and illnesses and poor morale among drug reviewers. Congress should immediately conduct meaningful oversight hearings on each of the drugs that has been withdrawn for safety reasons. Drug makers have benefited from PDUFA, making millions in profits off drugs that should never have been brought to the market. Congress must adequately fund the FDA’s drug approval activities and remove private influence from the equation.