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Advocacy at a Glance

January 8, 2021

Top-Line: FDA’s share of the appropriations and stimulus bill are described, with a link for more detail. This week’s Analysis and Commentary looks at the implications of the 2020 election cycle on future FDA funding. A summary of the agency’s 2020 accomplishments is also described with a link for more detail.

FDA Funding Provisions in the FY 21 Appropriations Bill/COVID-19 Relief Bill. FDA received a $42 million increase in the FY 21 (current year) Appropriations bill. It also received a $55 million boost for a broad variety of COVID-19 related activities as part of the Stimulus Bill. More about the monies and the purposes for which they were appropriated are in the Alliance’s analysis (here).

What Does the Election Mean for FDA Funding? This week’s Analysis and Commentary looks at the final election results and explores the implications for FDA funding.

FDA Recounts Its Year of Accomplishments in 2020. To start off the new year, Commissioner Hahn penned an FDA Voice article entitled: “2020 at FDA: A Year of Unparalleled Contributions to Public Health” (here). He points to his three strategic priorities for the agency: (1) unleashing the power of data, (2) empowering patients and consumers, and (3) promoting innovation, choice, and competition to advance scientific and medical progress. Through the FDA’s work on COVID-19 and its other mission-critical public health work, he describes significant progress on those priorities in 2020.

Pat Roberts Parting Thoughts on Threat to the Food Supply. Retiring Kansas Senator gave a December interview to Roll Call (here) in which he describes his concerns that our food supply, as well as our public health, is vulnerable to man-made threats. He underscores how bioweapons have been warehoused in the former Soviet Union and possibly elsewhere and our need for better defense to intentional attacks on food and people.

CDRH Advances Safer Technologies Program of Medical Devices. When Dr. Shuren, Director of CDRH, spoke to an Alliance webinar in early December, one of the new programs he described was the Safer Technologies Program (STeP),

a voluntary pathway for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics for diseases or conditions that are less serious than those eligible for the Breakthrough Devices Program.

Final guidance has just been published and CDRH expects to be able to accept applications for the program starting on March 8. A February 1 webinar will also be held on the program. More information is available here.

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