House Drafts FY 2018 FDA Budget With Same Appropriation Levels as 2017

Posted 27 June 2017 By Zachary Brennan

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The House Appropriations Committee on Tuesday released the fiscal year 2018 Agriculture Appropriations bill, which would enact a total of $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA).

That level of appropriations, which stands in stark contrast to President Donald Trump’s call to eliminate appropriations for FDA and run the agency entirely on industry user fees, would continue FDA’s budget authority (BA) appropriations at the current FY 2017 level.

The bill also appropriates $60 million as authorized in the 21st Century Cures Act, and includes language to allow FDA to receive transfers from the National Institutes of Health to support FDA’s new Oncology Center of Excellence. The legislation also includes language for FDA to use high carryover balances to help speed the review of new and generic drugs.

If enacted, total funding for FDA, including revenue from user fees, would be $5.2 billion – $490 million above fiscal year 2017, the committee said. A subcommittee will mark up the bill on Wednesday.

The Alliance for a Stronger FDA told Focus: “Especially in the current difficult budget environment, the members of the Alliance are grateful that the House has retained the agency’s FY 17 funding base and supported previously agreed upon bipartisan user fee agreements that are reflected in the House and Senate versions of the FDA Reauthorization Act (FDARA) legislation.”

Both the House and the Senate have yet to act on the user fee reauthorization legislation, though the House Energy & Commerce Committee and the Senate Health, Education, Labor & Pensions Committee have advanced the legislation. A Senate aide told Focus that floor time for the user fees bill has not yet been scheduled.

The Alliance added: “We look forward to continued fruitful discussion with the appropriations committees about FDA’s increasing responsibilities, including the costs of meeting new non-user fee activities contained in the FDARA legislation. A strong FDA--capable of fulfilling its broad mission--is a critical component of our nation’s health and safety.”

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Categories: Due Diligence, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: FDA FY 2018, FDA budget, FDA appropriations

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