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Advocacy at a Glance

April 16, 2021

Top-Line: The Alliance is beginning Hill Day meetings. Acting FDA Commissioner Woodcock responded to a wide range of questions during her meeting with the Alliance. The President’s FY 22 budget submission provides no insight on FDA funding. Dr. Cavazzoni has been appointed to head CDER.

Alliance to Begin Hill Day Meetings; Please Sign Up. The lack of any details about FDA funding in the President’s “preview budget” means that we may still be waiting for another month or more to know the administration’s baseline request for FY 22. With the potential for the appropriations committees to start holding hearings and taking actions in the interim, the Alliance is focusing its next Hill Day on refreshing Congressional offices on FDA’s enormous and diverse responsibilities, its many successes, and its growing resource needs to fulfill its mission.

Because this will again be a virtual effort, we are scheduling meetings across two days — April 28 and 29 — and looking for participants who can be available at any time between 9:00 a.m. and 5:00 p.m. on those days. We are hoping that Alliance members will be able to give us two-hour and half-day availability, but we are sure to have needs for coverage of single meetings. So, please let us know if you expect to have time but cannot yet be certain when on each day. For more information and to sign up, please contact Reed Diskey.

Acting Commissioner Woodcock Answered More Than 30 Questions During Alliance Meeting. Responding to a mix of pre-submitted and audience questions, Dr. Woodcock covered multiple topics around the FDA budget, priorities, and program initiatives. The central importance of data and technological modernization was a continuing theme, as was the need for the agency to have the resources to keep up with its increasing obligations. Some highlights are in this week’s Analysis and Commentary and in the Endpoints coverage (here). The entire 40-minutes of Dr. Woodcock’s remarks are here and the first 25 questions she answered are listed here.

Biden Budget Preview Provides No Insight on FDA Funding. As detailed in a supplement (here) to last week’s Friday Update, President Biden’s “preview budget” was short and gave us no information on his intended request for FY 22 funding for FDA. This week’s Analysis and Commentary provides more detail on the Alliance’s response and examines a new Biden administration initiative to increase translational biomedical research.

Dr. Cavazzoni Appointed to Head CDER. For more than a year, Dr. Cavazzoni has been the acting head of the Center for Drug Evaluation and Research (CDER). In an announcement this week, Acting Commissioner Janet Woodcock appointed Dr. Cavazzoni as the permanent Director of CDER. We congratulate Dr. Cavazzoni and look forward to continuing our support for CDER and her leadership.

Food Safety: A Key Part of FDA Data Modernization Plans. Food Safety News carried an essay on FDA’s technology and data modernization plans (TMAP and DMAP), addressing the question: how can a digital platform “better secure the food supply chain?” It makes valuable reading (see here).

“Building a Resilient Drug Supply Chain” Webinar on April 19. The Duke-Margolis Center for Health Policy is holding a public webinar discussing “the challenges we face in building a resilient drug supply chain, potential approaches to build a more robust, responsive, and resilient supply chain, and how we can assess our progress towards supply chain resilience.” More information can be found here.

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