Prescription Drug User Fee Act required drug and biologics manufacturers to pay fees for product applications, and other services
In 1992, President George Bush signed the Prescription Drug User Fee Act (PDUFA) and under the Clinton administration, the first user fees to support drug review activities were collected. Prescription Drug User Fee Act required drug and biologics manufacturers to pay fees for product applications and supplements, and other services. The act also requires FDA to use these funds to hire more reviewers to assess applications.
PDUFA participants credit Gerald J. Mossinghoff, President of the Pharmaceutical Manufacturers Association, with breaking the impasse over user fees. Given that underfunding at FDA was detrimental to industry, Mossinghoff identified common ground between the drug industry and FDA which he used to broker a deal that benefited both sides.
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Source: U.S. Food and Drug Administration
Credit: PDF: PDUFA Lays the Foundation