GPhA Applauds Congressional Passage of Generic Drug User Fees ‘Fix'



WASHINGTON, D.C. (SEP. 21, 2012) — The Generic Pharmaceutical Association (GPhA) today praised Congress for its swift action to pass legislation to allow the Food and Drug Administration (FDA) to collect new generic drug user fees beginning October 1, 2012.

The legislative action is required to fully implement the recently enacted Food and Drug Administration Safety and Innovation Act that authorizes $299 million annually in generic user fees to help fund the FDA generic drug approval and facility inspection programs.

“We are grateful to Congress, and to House Energy and Commerce Committee Chairman Upton and Ranking Member Waxman who first introduced this needed legislation, for their work to assure this much needed funding can get to the FDA and be put to work in the approval of safe, effective and affordable generic medicines,” said Ralph G. Neas, GPhA President and CEO. “By saving consumers, patients and providers nearly $200 billion dollars each year, generic prescription drugs have proven to be a vital component of the solution to controlling health care spending,” Neas added.

FDA-approved generic drugs provide the same treatment and therapeutic benefits as the counterpart brand name products but cost as much as 80 percent less than the branded versions. According to a July 2012 analysis by IMS Health, the use of generic drugs in the U.S. has saved Americans $1.06 trillion over the past 10 years and currently generates $1 billion in savings every other day. Moreover, savings are expected to increase over the next several years as generic versions of several blockbuster brand drugs enter the market.

“For consumers to fully benefit from the savings offered by generic medicines, it is critical that the FDA have the resources it needs, both through Congressional appropriations and by way of user fees, to guarantee the timely approval of new generic medicines,” Neas said. “Today’s action is a real win for patients, providers, seniors and all consumers who rely of prescription medicines to improve their lives,” he said.

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