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FDA Amendments Act passes Congress

This article was originally published in The Rose Sheet

Executive Summary

Legislation passed by the House Sept. 19 and approved by the Senate the following day contains provisions to create public-private Reagan-Udall Foundation tasked with "advance[ing] the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety." Foundation - to be led by a board of directors, four of whom will be representatives from the pharmaceutical, device, food, biotechnology and cosmetics industries - will "identify unmet needs" in the development, manufacture and safety and efficacy evaluation of cited products, as well as award grants for further research. The FDA Amendments Act also reauthorizes drug and device user fees and strengthens postmarket safety programs. Passage of the bill relieves worries about a possible FDA headcount reduction. The agency had warned last week that if Congress did not complete work on the measure by Sept. 21, it would be forced to send reduction-in-force notices to more than 1,700 employees due to insufficient user-fee revenues...
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