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Advocacy at a Glance

October 2, 2020

Top-Line: It is now official, FDA and the rest of the federal government are being funded by a short-term Continuing Resolution. Alliance members and media should be sure to sign up for our October 16 webinar with CDER leadership. This week’s Analysis and Commentary explores FDA provisions in the CR and how agencies like FDA operate under a CR. Also covered are FDA’s response to COVID-19 and creation of a new Digital Health Center of Excellence.

Reminder to Media: Friday Update is on-the-record. Further, we are always available to both our members and media to answer additional questions.

Dr. Cavazzoni and Dr. Stein to Address Alliance Members and Media on October 16. We are honored that Acting CDER Director Patrizia Cavazzoni, MD and Director of the Office of New Drugs Peter Stein, MD have accepted our invitation to speak at a special Alliance webinar, scheduled for October 16 from 9:30-10:30 AM. To sign-up to participate, please contact Reed Diskey. The event is limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.

FDA to Be Funded under Short-Term Continuing Resolution through December 11. After some back-and-forth negotiating over additional funds for the farm programs and similar items, the House passed the CR, followed by Senate passage and the President’s signature. Funding under the CR extends through December 11 and no one knows what will happen then. It is possible that Congress will wrap all or most of the 12 appropriations bills into an omnibus funding bill that will cover the remainder of the year. Of the alternatives, the most likely would be Congress extending the CR  to mid-February or March.

The election is likely to have a large role in what happens. It is widely assumed that a Biden victory coupled with a Democratic majority in the Senate would result in a CR that extends until next year, when they have control. A Trump victory and a Republican-majority Senate is more likely to seek a funding deal this year, but that would still depend on what the House wants to do.

FDA’s Response to COVID-19: CDRH Numbers. FDA Commissioner Hahn has said:

If you want to know the U.S. Food and Drug Administration’s impact on COVID-19, look no further than the numbers.

To demonstrate the truth of that, CDRH has published an infographic (here) that illustrates the Center’s many COVID-19-related activities. For example, CDRH has: authorized 516 medical products under EUAs; reached out to 1,000+ manufacturing sites across 12 countries to assess supply chain vulnerabilities; and issued 23 guidance documents and 12 EUA templates.

FDA Launches Digital Health Center of Excellence.  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 health care space. There are four areas of focus for the new Center of Excellence: empowering stakeholders; connecting stakeholders; sharing knowledge; and innovating regulatory approaches.

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