Advocacy at a Glance

Topline: FDA’s budget grew in the just completed FY 20 funding cycle. The Alliance is fully engaged in supporting the agency’s resource and funding needs in the upcoming FY 21 cycle. The Alliance’s Hill Day will be March 18 and there are three member-only activities slated for the next 5 weeks.Before Focusing on FY 21 Funding: A Recap of FY 20.  Funding for current year, FY 20, was finalized on December 20, just before the holidays. After 2 years of very large increases, FDA was able to sustain momentum and achieve a 3% or $91 million increase over FY 19. This brings FDA’s total budget authority funding to $3.160 billion. The Alliance’s complete analysis of the FY 20 FDA appropriation is >here. For a longer-term context, read our commentary here.The increase included $48.9 million more for medical product programs and $31.5 million for food safety programs. A third component, $12.1 million, was added to pay for infrastructure improvements at White Oak and other rented facilities. Apart from the annual BA appropriation, FDA will again receive $75 million to implement programs established under the 21st Century Cures Act. Also, FDA will receive $20 million of “no-year” monies for equipment and facilities used for FDA seafood safety activities. This will expand research labs and address deferred maintenance.Key FY 21 Funding Dates Set; With Budget Set, House’s Goal is to Finish by July 1. At the invitation of the House Speaker, President Trump will deliver his State of the Union (SOTU) address on the evening of Tuesday, February 4. Our understanding is that OMB plans to follow the usual pattern: release the President’s FY2 21 budget request on the following Monday, February 10. Some slippage to that date might occur for practical or political reasons.House Majority Leader, Steny Hoyer, told reporters that the House is committed to passing appropriations bills by June. This was the self-imposed House deadline in 2019 and they passed 10 of the 12 appropriations bills by that date. The process should be easier this year since last year’s hard-fought budget agreement set spending ceilings for FY 21 when they were taking care of FY 20 budget caps. However, the appropriations bills may prove much harder to shape because the non-defense spending ceiling will increase by only $5 billion dollars, while last year’s increase (FY 20 compared to FY 19) was $25 billion (see chart on page 11 here).Our Hill Day, Your Hill Day: Both Are Important. The Alliance’s Hill Day will be Wednesday, March 18. Please mark your calendars. If possible, sign up soon by e-mailing Reed Diskey. We will be setting up dozens of Hill meetings, so we can use participants all day. However, let Reed know if you can only be available in the morning or the afternoon. You do not have to be an Alliance member to be part of our Hill Day.Many of our Alliance members also hold their own Hill days and we encourage you to include FDA’s increased funding needs among your “asks.” If you plan to do so, let us know the date and your needs (a one-pager, a paragraph, a chart, etc.) and we will be happy to support your efforts with regard to FDA funding. To follow-up on this, please contact Steven Grossman.Alliance Member-Only Opportunities in January and February. In the coming months, we expect to have a number of opportunities for Alliance members to interact with Congress and the Executive Branch on the increased resource needs of the FDA (budget, personnel, infrastructure). Here are the first set:

• January 21 (afternoon) meeting with Dr. Peter Marks, Director of CBER at White Oak
• February 4 (afternoon) meeting with Dr. Jeffrey Shuren, Director of CDRH at White Oak
• February 12 (all day) meetings with staff of members of the House and Senate Agriculture Appropriations Subcommittee and Subcommittee Clerks

Please let Reed Diskey know if you would be interested in participating in any of these three meetings. We are limited to about a dozen Alliance members at each of the White Oak meetings and will need a similar number for this first round of Hill meetings. From those who respond, we will select a group that is representative of the Alliance and its interest in FDA’s resources. Over the course of the year, we hope to involve a broad range of our Alliance members in at least one of these interactive meetings. (Note: If you are unsure whether you are an Alliance member, contact Steven Grossman.)FDA is Its People ... and They Need Our Support. This week’s Analysis and Commentary discusses why “FDA is its people” and why our efforts to increase agency resources includes a strong, well-educated workforce.