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Members Introduce Bipartisan Legislation to Improve FDA Generic Drug Approvals

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Location: Washington, DC

Rep. Tim Murphy (R-PA), House Energy and Commerce Health Subcommittee Chairman Joe Pitts (R-PA), Ranking Member Henry A. Waxman (D-CA), and Subcommittee Ranking Member Frank Pallone (D-PA) yesterday introduced the Generic Drug and Biosimilar User Fee Act of 2012 (H.R. 3988), which authorizes a generic drug user fee proposal that was recently agreed to by the U.S. Food and Drug Administration and generic drug manufacturers. The user fee provides resources to the FDA to ensure that patients have access to lower cost generic drugs more quickly.

Murphy said, "This historic legislation, based on an agreement between the FDA and the generic pharmaceutical industry, will allow us to bring less expensive therapies to market much more quickly. Less expensive drugs means improved access to care for patients, and that means fewer costly complications and hospitalizations due to untreated conditions. At the same time this legislation will give the FDA the resources it needs to inspect both domestic and foreign generic drug facilities, better securing our drug supply chain."

Pitts said, "Under the terms of the Generic Drug User Fee agreement that industry and FDA have negotiated, industry will pay approximately $1.5 billion over the next five years, in exchange for more efficient and predictable review of generic drug applications and increased inspections of drug facilities. By increasing the predictability, efficiency and transparency of FDA regulations, we can save patients, promote innovation and protect jobs without sacrificing quality or safety."

Waxman said, "This bipartisan legislation will give FDA the authority and resources it needs to review generic drug and biosimilars applications in a timely and effective manner. For some time, FDA's generic drug review program has been starved of resources, which has meant fewer generic drugs on the market, and consequently higher medication prices for American patients. At long last, this legislation will help turn this untenable situation around."

Pallone said, "This bill establishes two critically important programs at FDA that will help speed the delivery of low-cost drugs and other promising medicines to patients. Generics have saved more than $824 billion over the last decade and have substantially reduced costs to consumers. Both programs created by this bill will have significant impact on health care, and I look forward to its expeditious passage."


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