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Advocacy at a Glance

October 16, 2020

Top Line: The election and the new Congress will bring a few leadership changes to the committees that oversee FDA. This is explored below and  in more detail in this week’s Analysis and Commentary. There is discussion about FDA and the necessity of hard decisions. A listening session on digital health and a webinar on food safety are announced.

Congressional Committees Overseeing FDA Will Have Some Changes in the New Congress.  As described in this week’s Analysis and Commentary, the committees with responsibility for FDA will have a lot of stability with some pockets of great change. Likely to have mostly the same leadership: the Senate Appropriations Committee and the Democrats on Senate HELP and House Energy and Commerce. Likely to have new leadership: the House Appropriations Committee will need a new chair; and the Republicans on Senate HELP and House Energy and Commerce will shift due to retirements and House Republican term limits. There will be lots of new members on all the committees.

Being FDA Means Always Having to Make Hard Decisions. Three articles this week highlighted the difficulty of decisions that FDA has to make in real-time. Dr. Hahn addressed (here) the start-stop-restart pattern of some COVID-19 trials, citing it as evidence that the system is working to assure safe and effective products. A Science magazine article (here) explores whether the first COVID-19 vaccine — which might not be strongly beneficial or work for everyone — could have the effect of disrupting ongoing COVID vaccine trials that might produce better products. Finally, an article (here) reports on a meeting where CBER Director Dr. Peter Marks and other FDA officials describe the thin resources and hard decisions involved in setting priorities for FDA activities during the pandemic. Cell and gene therapy products — one of CBER’s top priorities and already understaffed when Dr. Marks talked to the Alliance in January (summary here) — has been particularly hard-hit.

FDA’s Digital Health Center of Excellence: Listening Session. The new center (here), part of CDRH, is designed to support the growth in digital health technology. It is a recognition that translating digital advances into tools that benefit consumers brings new stakeholders to FDA, including ones that are also new to the healthcare space. There are four areas of focus for the new Center of Excellence: empowering stakeholders; connecting stakeholders; sharing knowledge; and innovating regulatory approaches. To begin the process of receiving input from stakeholders, FDA has scheduled a listening session on Monday, October 19 from 11:00 a.m. to 12:30 p.m. ET. Details are here.

FDA’s New Era of Smarter Food Safety: Upcoming Webinar. On Monday, October 26, 2020 from 3:00 to 4:00 p.m. ET, CFSAN will host a webinar, highlighting the first 100 days since FDA issued its blueprint for the New Era of Smarter Food Safety. Deputy Commissioner for Food Policy and Response Frank Yiannas will make opening remarks about the new approach FDA is taking to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system. He will be followed by leaders of each of the core elements: Tech Enabled Traceability; Smarter Tools and Approaches for Prevention and Outbreak Response; New Business Models and Retail Modernization; and Food Safety Culture. Registration is required by 5:00 p.m. ET on October 22, 2020. More information on the initiative is here.

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