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Advocacy at a Glance

July 10, 2020

Top-Line: The House Appropriations Committee approved an FY 21 Ag/FDA funding bill with an increase of $41 million for FDA. CBER Director Dr. Peter Marks addressed Alliance members and the media on July 8 on vaccine development. There were nearly 100 participants and his remarks were widely covered by the media. This week’s Analysis and Commentary summarizes his remarks. The next Alliance webinar — with former FDA Chiefs of Staff — is on July 23.

House Appropriations Committee Votes for $41 Million Increase for FDA in FY 21. In the first step of the FY 21 funding process, the Appropriations Committee adopted an Ag/FDA bill that

includes a net increase of $40,828,000, including increases for the following programs or initiatives: (1) Strengthening Response Capabilities for Foodborne Outbreaks; (2) Cannabis and Cannabis Derivatives; (3) Artificial Intelligence and Other Emerging Technologies; (4) Transform Medical Device Safety, Cybersecurity, Review, and Innovation; (5) Compounding; and (6) Modernizing Influenza Vaccines (numbering added).

Along with other appropriations bills, the Ag/FDA spending bill is expected on the House floor during the week of July 20 or July 27.

Alliance Response to House Action.

The Alliance thanks the House Appropriations Ag/FDA Subcommittee for its continuing support of the resources FDA needs to meet its expanding responsibilities. We view the proposed $41 million increase in FY 21 as a vote of confidence in the agency, given the severe budgetary constraints for all federal programs. We believe the FDA will still need more resources in the coming fiscal year to fulfill its mission and we will continue to work with Congress to achieve that end.

Why Are FY 21 Spending Limits So Tight? The budget cap on non-defense spending for FY 21 is only slightly higher ($5 billion) than actual FY 20 enacted spending levels. Thus, there was never any expectation that the bulk of non-defense programs were going to receive added funds in FY 21. The problem is far worse because VA healthcare spending is expected to increase by more than $12 billion in FY 21. This would eat up all available money for increases and might require more than $7 billion in non-defense program cuts.

That immediate problem has been solved in the House by moving the additional VA funding (and some spending in other bills) under the category of no-year emergency spending, which is not covered by the spending caps. It is uncertain whether the Senate will adopt the same approach. Even so, there will be little money for increases in non-defense programs in FY 21.

UPCOMING ALLIANCE WEBINAR: Crisis Preparation and Action at FDA: Insights from Past Experiences. On July 23 at 10:30 a.m. the Alliance will host a “members and media only” webinar featuring three former FDA Chiefs of Staff. They will discuss how the agency prepares for crises, their own experiences at FDA, the impact on other agency responsibilities, and how stakeholders and other third parties can support the agency. We will send out more information next week, but here is the link if you want to sign up now.

FDA to Release the New Era of Smarter Food Safety Blueprint on July 13 at 1 p.m. The FDA previously announced its goal of moving toward a more digital, traceable, and safer food system. On Monday, visit the New Era of Smarter Food Safety web page at 1:00 p.m. to hear remarks by Commissioner Hahn and Deputy Commissioner Frank Yiannas. They will describe FDA’s blueprint for modernizing its approach to food safety and reducing the number of foodborne illnesses.

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