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Rep. Duncan Leads in Calling on Congress to Prevent Provision to Delay FDA User Fee Authorization

August 16, 2022

Washington, D.C.– Congressman Jeff Duncan led a bipartisan letter to Speaker Nancy Pelosi and Republican Leader Kevin McCarthy to prevent the inclusion of a controversial provision that inevitably delays the final Food and Drug Administration (FDA) User Fee program’s reauthorization.

"I led a bipartisan letter with 14 of my fellow Members of Congress to Speaker Pelosi and Leader McCarthy to prevent the inclusion of a controversial provision that inevitably delays the final Food and Drug Administration (FDA) User Fee program’s reauthorization,” said Congressman Jeff Duncan. “House Leadership and the Energy and Commerce Committee worked hard to make the House version of the reauthorization bipartisan and free of controversy so that it could pass as quickly as possible. Unfortunately, the Senate has undermined these efforts by including mandatory product listing for dietary supplements in the language. The User Fee programs reauthorization is not the appropriate vehicle to advance this provision, and its inclusion will necessitate further debate that will only delay passage of the underlying legislation.”

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Background:

First established by Congress in 1992, the User Fee programs collect fees from pharmaceutical, generic, biosimilar, and medical device companies, allowing FDA to accelerate the approval of life-saving drugs and other medical products. Every five years, Congress must reauthorize these agreements, which do not apply to dietary supplements and other food products. A delay in the passage of this reauthorization due to the inclusion of unrelated provisions would be unfortunate and detrimental to the development of new products in areas supported by user fees.