Volume 95 Issue 34 | p. 17 | Concentrates
Issue Date: August 28, 2017

Trump signs FDA user fee legislation

Department: Government & Policy
Keywords: pharmaceuticals, drug safety, FDA
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FDA will keep collecting user fees for safety reviews of new drugs under a new U.S. law.
Credit: Shutterstock
Photo shows a prescription pill bottle without a lid, on its side spilling out tablets.
 
FDA will keep collecting user fees for safety reviews of new drugs under a new U.S. law.
Credit: Shutterstock

President Donald J. Trump on Aug. 18 signed into law legislation (H.R. 2430) that will allow the U.S. Food & Drug Administration to continue collecting fees from industry to help pay for the agency’s safety and efficacy reviews of new drugs and medical devices. The legislation renews FDA’s authority to collect fees from fiscal 2018 through fiscal 2022. The agency’s current authority expires Sept. 30, the end of fiscal 2017. Although President Trump urged lawmakers to allow FDA to collect 100% of its total budget from industry paid fees, he did not get his wish. The new law instead authorizes FDA to collect about $1.4 billion, or 28% of its budget, in user fees from pharmaceutical companies and medical device manufacturers each year. It also aims to improve postmarket drug safety and gives generic drug manufacturers earlier access to FDA staff in the hope of getting more low-cost drugs to market. The measure passed the House of Representatives on July 12 and the Senate on Aug. 3.

 
Chemical & Engineering News
ISSN 0009-2347
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