FDA releases draft of GDUFA goals

WASHINGTON — Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

The act, which still requires approval from Congress, would give the FDA $1.5 billion over five years through industry user fees. The law, also known as GDUFA, has long been a goal of the generic drug industry, which sees it as a way of expediting the agency's review of generic drugs and whittling down its massive backlog of thousands of applications currently awaiting review and taking action on 90% of the generic drug approval applications within 10 months after the date of submission. The law also would enhance the FDA's ability to inspect foreign manufacturing sites; according to the Government Accountability Office, the FDA was able to conduct good manufacturing practice inspections at 11% of the foreign sites in its database, compared with 40% of domestic sites.

"The Generic Drug User Fee Act is a milestone for the generic drug industry and a major win for American healthcare consumers," Generic Pharmaceutical Association president and CEO Ralph Neas said. "This program, as negotiated, will result in expedited access to low-cost, high-quality generic drugs for Americans and will further safeguard the quality and accessibility of our nation's drug supply."

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