Article: Survey Points To PDUFA As Reason For Low FDA Morale.

Washington Editor

WASHINGTON - Internal dissatisfaction is mounting at the FDA, according to a newly released survey, and the agency's user-fee system seems to have a big role in its off-putting atmosphere.

"Concerns about the user-fee programs were not surprising," Susan Wood, a former high-ranking FDA official, told BioWorld Today. Survey respondents indicated multiple deleterious consequences of the Prescription Drug User Fee Act (PDUFA) and similar laws, which overall these days account for nearly a fifth of the FDA's annual budget.

First, Wood pointed to frustration among FDA staff who feel pressure working under the laws' review-time ...

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