Senate Committee to Vote on FDA User Fee Reauthorizations

Regulatory NewsRegulatory News | 03 May 2017 |  By 

Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements.

The current, five-year agreements are set to expire 30 September 2017, though if Congress fails to act before its summer recess, thousands of FDA employees would receive layoff notices.

The proposed reauthorizations, grouped together as the FDA Reauthorization Act of 2017, would increase the fees paid to FDA over the next five years in exchange for more timely reviews of some medical products, more industry interactions with the agency and more guidance from the agency on particular areas.

The Senate committee has already held two hearings on the user fee agreements, which offered support from FDA experts and witnesses representing patients and the manufacturers of drugs and devices.

On Tuesday, a House committee also considered four medical device bills to add onto the user fee legislation.

For more information on the goals agreed to in each of the four areas, see Focus’ previous coverage on PDUFA, MDUFA, GDUFA and BsUFA.

One-Pager from Sen. Lamar Alexander (R-TN)

Text of the bill


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