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Advocacy at a Glance

May 23, 2019

Friday Update on Thursday This Week. The House Ag/FDA appropriations subcommittee finished its mark-up this morning (Thursday, May 23). We wondered: why wait for Friday to deliver Thursday news? We will be back on regular schedule for the May 31 edition of the Friday Update.

Alliance for a Stronger FDA Praises FDA Funding Levels Contained in the House Bill.

The Alliance is very pleased by the House Ag/FDA appropriations subcommittee’s proposed $184 million increase in budget authority (discretionary) spending for FDA for FY 20. While this is less than the Administration’s request, the proposed 6% increase represents a substantial investment in the agency’s growing mission and importance.

House Subcommittee Proposes $184 million (6%) Increase for FDA’s FY 20 BA (Taxpayer) Funding. The House Ag/FDA released a combined press release and statement that said:

The FDA receives a total of $3.26 billion in discretionary funding in the bill, $184 million above the 2019 enacted level. Total funding for the FDA, including revenue from user fees, is $5.86 billion. Within this total, the Committee provides target increases for medical product and food safety activities, including new initiatives to revolutionize the safety of the nation’s blood supply and to enable faster responses to foodborne illness outbreaks. In addition, the bill includes a strong focus on continuing FDA’s efforts to advance generic drug reviews and increase medical product manufacturing in the U.S. The bill also appropriates $75 million to accelerate medical product development as authorized in the 21st Century Cures Act.

Interested in How a Specific Center Would Fare Under the House Bill? This week’s Analysis and Commentary provides key points about the House subcommittee action and includes a table showing how the proposed $184 million increase in budget authority (BA) appropriations would be spread among the Centers and other budget lines. Because the bill text does not directly provide these numbers, the table is derived from multiple sources and involves several calculations. Our estimates should be accurate to ± $3 million per budget line, but we urge readers to treat this as a preliminary analysis, not a definitive one.  We should have more information when the committee report is released following the full committee mark-up (no earlier than June 4).

Budget Deal Facing Even Rougher Waters. Over the last 2 weeks, prospects for a budget deal seemed to be improved (explained in more detail here). That culminated in news that the four Congressional leaders — McConnell, Schumer, Pelosi, and McCarthy — were meeting to see if they could negotiate a bipartisan budget deal that would raise budget ceilings and supercede a September vote to raise the debt ceiling,  At week’s end, things look less promising — with Republican/Democratic rifts over an infrastructure package and the White House expressing less interest in bipartisan solutions.

Is the $75 Million for 21st Century Cures Significant? Yes. The $75 million — the maximum available for FY 20 — is an affirmation of the House’s continued commitment to the Cures program. The 2016 legislation created a 9-year/$500 million venture, the FDA Innovation Fund, to implement parts of the legislation. At the time, the Senate HELP and the House Energy and Commerce committees generated the funds from changes in mandated programs. Thus, the Cures funds are neither BA (budget authority) nor UF (user fees). The deal that created the Innovation Fund (and also created a similar but much larger Fund at NIH) was premised on the fact that these funds would be subject to their inclusion in an appropriations bill, but otherwise come from non-discretionary funding and not be counted against budget ceilings. The $75 million is in addition to the $3.26 billion the subcommittee is proposing for BA funding.

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