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Advocacy at a Glance

April 9, 2021

Top-line: Acting FDA Commissioner Dr. Janet Woodcock will address the Alliance on April 14. A preview of President Biden’s Budget Request will be released on April 9. Reconciliation on the President’s Infrastructure Request will have an unknown impact on appropriations. This week’s Analysis and Commentary describes what we might learn from a limited budget release.

Acting FDA Commissioner Dr. Janet Woodcock to Address Alliance on April 14. For Alliance members and media: please join us for a virtual presentation by Acting FDA Commissioner Janet Woodcock on April 14, from 11:30 a.m. to 12:15 p.m. Dr. Woodcock will discuss FDA’s priorities and resource needs, as well as data modernization and other infrastructure investments that are critical to maintaining and expanding FDA’s status as the world’s regulatory “gold standard.”

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 this special event.

Preview of President’s Budget Request to Be Released April 9. Later today, the Biden administration plans to release documents that “preview” its requested FY 22 spending levels for each federal agency. It will cover discretionary spending but is not expected to cover mandatory spending or changes to the tax code. This is analogous to President Trump’s “skinny” budget, released March 16, 2017, which was limited to topline discretionary appropriations tables and summary information for each agency. Detailed explanatory information about longer-term budget proposals and line-by-line budget numbers were not distributed until May 23. President Biden is, similarly, planning for a full budget release in May.

We expect today’s budget “preview” to have limited information on FDA, whereas the FDA portion of the full President’s request will be more than 300 pages. Because FDA has so many vastly different responsibilities and multiple funding sources, we expect the situation will be similar to four years ago — a lot of ambiguity about how much is being requested for FDA and what programs and initiatives are receiving increased support.

Accordingly, this week’s Analysis and Commentary reviews some of the ways in which “headline” coverage may not provide an accurate picture. Later today or tomorrow, as a supplement to this week’s Friday Update, the Alliance will provide authoritative analysis of whatever FDA information is released.

Reconciliation and the President’s Infrastructure Request: Unknown Impact on Appropriations. With this year’s late start and today’s limited budget information, it is assumed that the appropriations process will play catch up until the Fall. The potential for another reconciliation bill raises the possibility of further delays in appropriations or even that some budget issues will be addressed in reconciliation. The situation is still being analyzed — substantively and politically — and we will keep readers aware of any new developments. Roll Call’s initial analysis is here.

FDA Biennial Science Forum Scheduled for May 26 and 27. Every two years, FDA holds a two-day workshop that is intended to

inform the public about the groundbreaking science conducted at the Agency and to show how scientific research is used in FDA’s regulatory decisions to protect and promote public health.

This year’s Forum will highlight several areas of FDA research, including: (1) improving clinical and postmarket evaluation; (2) substance use, misuse, and addiction; (3) product development and manufacturing; and (4) medical countermeasures, infectious disease, and pathogen-reduction technologies.

For more information and to register, go here.

FDA-Track: The Agency’s Performance Monitoring System. This week’s announcement of new and additional performance metrics for the Center for Veterinary Medicine serves as a reminder that every center and major office at FDA is accountable through a formal performance monitoring system. The entire system is on the FDA website (here).

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