Advocacy at a Glance

Top-Line: Appropriations bills are delayed but set to begin moving. Getting a budget resolution (or, at a minimum, a measure to "deem" a discretionary allocation to the appropriations committees) is key. Final appropriations action is uncertain. Upcoming Alliance webinars - Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin (July 14) and CDRH Director Jeff Shuren (July 22).

Appropriations Schedule: Short-Term. In most years, appropriations bills are scheduled for House floor consideration at the end of June and in July. This year has been altogether different with the President’s Budget Request being released on May 28, the latest ever. However, the House plans to catch up to the traditional schedule as quickly as it can starting with subcommittee mark-ups on June 25. The committee is planning to report 6 of the 12 appropriations bills from the Full Committee by July 1 and complete subcommittee mark-ups on two more. For some agencies (including FDA), their day to testify in front of the House Appropriations Committee is likely to come after the bill affecting them has been marked-up.

With specific reference to the appropriations bill covering Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, the House Subcommittee mark-up is scheduled for Friday, June 25 and the full committee mark-up for Wednesday, June 30. There is talk of Senate mark-ups starting in July, but nothing is concrete.

Deeming Resolution Key to House Action on Funding Bills. Throughout the last decade, the Budget Control Act of 2011 dictated the spending permitted each year for defense and non-defense programs. While Congress often raised those ceilings, they provided a nominal starting point for the Budget and Appropriations Committees with which to work.

With no pre-set spending limitations for FY 22 and little prospect of a FY 22 Budget Resolution, the House Budget Committee is moving forward with what is called a “deeming resolution.” Essentially, it clears the way for appropriations bills to start moving forward in the House by assuming a total level of spending that has not actually been agreed upon. For FY 22, the amount proposed by the House Democratic leadership to be deemed is closely aligned to the President’s Budget Request. This is the ideal starting spot for agencies, such as FDA, that would receive large increases under the President’s request.

Appropriations Schedule: Long-Term. Speculation has started about whether this is going to be another “hurry up and wait” year for appropriations bills. Most years start with a strong effort by the House, followed by Senate committee action. By July, we usually have a good sense of what a final bill might look like. Then things bog down, so a Continuing Resolution (CR) to avert a government-wide shutdown on October 1 becomes necessary, and it can take until December and beyond for a final deal to be reached. No one wants a CR, but a PoliticoPro article, based on interviews with Senate Appropriations Committee members, revealed that many expect at least an initial CR on October 1 and cannot rule out that a full-year CR will be suggested. A year-long CR is the worst case for federal agencies, such as FDA, that have expanding missions and increasing responsibilities.

Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media:

Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin (July 14, 1:30-2:30 PM ET). The monies for field programs are spread throughout the agency budget, but the responsibility for inspections, compliance, and enforcement is centralized in the Office of Regulatory Affairs (ORA), run by the ACRA. More than 5,000 FDA employees are part of ORA. During this webinar, Associate Commissioner McMeekin will describe how ORA works and the challenges in managing a global workforce. This is her first appearance addressing the Alliance. To sign-up, please register here.

CDRH Director Jeff Shuren (July 22, 10:00-11:00 AM ET). Wholly apart from the pandemic, CDRH has never been busier as it addresses a surge in innovation in medical devices and the impact of transformative technologies such as artificial intelligence and digital health. CDRH Director Dr. Jeff Shuren will provide a view of CDRH’s current opportunities and challenges and discuss how the FY 22 budget request will help them. To sign up, please register here.

These events are limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.

Alliance Holds Webinar with FDA’s Food Safety and Animal Health Leadership. On June 16 the Alliance hosted a webinar to spotlight FDA’s responsibilities and plans as they relate to food and animal health. During the sixty-minute presentation, members heard from Deputy Commissioner for Food Policy and Response Frank Yiannas, CFSAN Director Susan Mayne, and CVM Director Steven Solomon who fielded questions from members. A transcript, video link, and relevant news articles will be forthcoming in the next edition of the Friday Update.

Join the Alliance: The Bigger Our Voice, The More Effective We Are. The Alliance has more than 150 members who, taken together, represent every segment of the FDA stakeholder community. Our collective voice is important to the future of the FDA. It is reflected in the breadth of Congressional offices interested in the Alliance’s viewpoint, the widespread media coverage of our positions and activities, and the progress in FDA taxpayer funding that has occurred over the last 15 years. There is still much to do in the long-term but also in advocacy and education about the President’s requests for a $343 million increase in BA (taxpayer) support for FDA in FY 22. Data and technology modernization is a particularly acute need.

Our voice--our advocacy for FDA resources--would be even stronger if our membership grew from 150 to 200 members. If you are not yet a member, we would appreciate your consideration. To chat further, contact Steven, Phil, or Reed. This week’s Analysis and Commentary is devoted to the benefits of Alliance membership. Please give it a read.

ICYMI: FDA On Eating Cicadas. According to FDA: Cicadas might seem like a crispy, protein-packed snack, but people with seafood allergies should think twice about eating them.