Advocacy at a Glance

Top-Line: The President’s FY 22 Budget is being released on May 28. An analysis of the FDA request will be provided to Alliance members following our internal review. Thus far the Alliance is recommending an increase of at least $200 million over FY 21, and will make further recommendations based on the submitted budget. Two successful Hill Days with Senate staff were completed this week. Two upcoming webinars — FDA’s Food and Animal Health Leadership (June 8) and CDRH Director Jeff Shuren (July 22).

President’s Budget Release May 28 (Today). The long-awaited and long-delayed Budget Request from President Biden will be released later today.

Over the course of a couple of hours, The Office of Management and Budget (OMB) will release the overview of the President’s request and then the departmental budget with short sections on each agency. Finally, the Congressional Justification (CJ) — with extensive detail on each agency — will be released. Typically, the CJ for FDA is 300 to 400 pages.

Complex FDA Budget Means Announced Totals May Not Provide an Accurate Picture. Today’s Analysis and Commentary reviews the several different ways in which the initial OMB “headline” number may overstate and oversimplify the request for FDA. Notably, pre-negotiated user fee increases count as new money, as would any proposed new user fee programs. In addressing the agency’s total allotment, the $700 million in tobacco user fees distorts the actual monies available for food safety and medical products.

We will provide more details and further clarification later today (May 28) once the President’s Budget Request is available and we have analyzed it.

Alliance Request Focuses Solely on BA Appropriations. In advance of receiving the President’s request, the Alliance has urged Congress to provide the Food and Drug Administration (FDA) with “no less than $200 million (6%) above the FY 21 funding level for Budget Authority (BA) appropriations.” We are hoping the President will request more.

The critical distinction is that BA funding — which comes from taxpayer monies — is the money that protects the public health and assures that FDA can fulfill its mission. User fees are incredibly valuable, indeed essential, but are intended for specific purposes, usually ones that facilitate FDA’s ability to determine safety and efficacy of medical products more quickly (excluding tobacco user fees that have a completely different purpose).

We believe that the primary beneficiary of FDA’s activities is the American public. Accordingly, it is critical that the public remains the largest source of FDA funding.

More Hill Days Completed. With completion of this week’s Senate staff meetings, the Alliance will have held more than 65 Hill meetings in the last month. In doing so, we refreshed Congressional staff on FDA’s enormous and diverse responsibilities, its many successes, and its growing resource needs to fulfill its mission. Our key points are here and our messaging is described here. In general, we found positive attitudes toward FDA and its resource needs. It is too soon to know if this will translate into visible support from Representatives and Senators. That might depend on what is in the President’s Budget Request.

House Appropriation Subcommittee markups are expected to begin on June 24, with full committee action starting the following week. Specific dates for the Agriculture/FDA Subcommittee have not yet been announced. While the Senate Appropriations Committee has not made a similar announcement, Senate Committee action routinely happens soon after House Committee action.

Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media. We met with Acting Commissioner Janet Woodcock in April and with CDER Director Patrizia Cavazzoni earlier this week. You can view the video from this week’s webinar with CDER Director Cavazzoni here and read the transcript here. We have two more webinars scheduled and will announce more soon:

• FDA’s Food and Animal Health Leadership (June 8). For Alliance members and media: please join us for a virtual presentation on June 8 from 2:00 to 3:00 p.m. ET by Deputy Commissioner Frank Yiannas, CFSAN Director Susan Mayne, and CVM Director Steven Solomon. To sign up, please register here.
• CDRH Director Jeff Shuren (July 22). For Alliance members and media: please join us for a virtual presentation by CDRH Director Dr. Jeff Shuren on July 22 from 10:00 to 11:00 a.m. ET. To sign up, please register here.

If you are not an Alliance member and want to participate, please contact Steven Grossman to be our guest at these special events.