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Guthrie Votes to Deliver New Treatments, Cures to Americans

Washington, DC– Congressman Brett Guthrie (KY-02), vice chair of the House Committee on Energy and Commerce Subcommittee on Health, today joined a bipartisan majority of members of the full committee to advance the FDA Reauthorization Act (H.R. 2430), which would reauthorize the Food and Drug Administration (FDA) user fee programs, expediting the FDA review process for new treatments and cures for patients.

The FDA Reauthorization Act would reauthorize four user fee programs, known by the title of amendments made to previous legislation: The Generic Drug User Fee Amendments (GDUFA), the Prescription Drug User Fee Amendments (PDUFA), the Biosimilar User Fee Amendments (BsUFA), and the Medical Device User Fee Amendments (MDUFA). These programs allow the FDA to collect user fees from companies with respective drug or device applications, helping to fund the process for reviewing new medical technologies, treatments, and cures.

Guthrie joined Health Subcommittee Chairman Michael Burgess (TX-26) in authoring a recent op-ed explaining the importance of the FDA user fee programs.

“The user fee programs – GDUFA, PDUFA, BsUFA, MDUFA – may look and sound like wonky acronyms, but they are critical to patients, drug and device manufacturers, and the millions of Americans who work to deliver new treatments and cures to Americans,” wrote Guthrie and Burgess in the Hillon Wednesday. “The FDA Reauthorization Act will help patients live better and healthier lives. This is an important win not just for our country as a global industry leader – but for each of the individuals in our communities, our families, and among our friends and neighbors who need treatments and cures to live better and healthier lives.”

 

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