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Advocacy at a Glance

March 27, 2021

Top-Line: OMB will provide a preview of the President’s FY 22 Budget Request next week. CBER releases its five-year strategic plan. This week’s Analysis and Commentary explores how the Alliance and its members can demonstrate support for the agency to Congress. Principal Deputy Commissioner Abernethy will leave the agency and her contributions are described. FDA Voices provides insight into FDA’s approach to inspections during the pandemic.
OMB to Release Preview of FY 22 Budget Request Next Week. The White House announced that it will release a preview of the President’s FY 22 budget request next week (reported here). The preview will include high-level numbers and details. The full Budget Request (with 300+ pages of details for FDA alone) is expected in May. In 2017, we described President Trump’s FY 18 preview (“the skinny budget”) for FDA (here). In addition to the lack of detail, it was part of a Budget Request that cut HHS by 16% and USDA by 20%. Accordingly, we had two further columns to address questions (here and here).

We expect President Biden’s request to be more favorable to FDA than the one we faced then. However, the problem of deriving meaning from limited information will be the same. (Note: Thanks to Congressional champions, FDA ultimately received a small increase in FY 18 and the President requested an exceptionally large increase for the agency the next year.)

CBER Releases 5-Year Strategic Plan. The FDA Center for Biologics Evaluation and Research (CBER) has released its strategic plan (here) covering its approach to its mission and responsibilities from 2021 to 2025. The Center’s goals during this five-year period involve facilitating product development through the integration of advances in science and technology; through research, addressing challenges in medical product development and evaluation; increasing preparedness for emerging threats; and managing for strategic excellence and organizational accountability.

The plan also discusses CBER’s near-term priorities: (1) addressing the COVID-19 outbreak; (2) developing a regulatory program for individualized or bespoke therapies; (3) facilitating compliance with human cells, tissues, and cellular and tissue-based product regulations; (4) advancing manufacturing technologies for biologic products.

Congress Needs to Hear Your Support for FDA. The Alliance is active year-round, proactively working with Congress, media, and the public to emphasize the importance and resource needs of the FDA. We hope our members are doing that, too. In the course of the year, there are several crucial times where we need specific concerted action. As explained in this week’s Analysis and Commentary, this is one of those times. Please help us to help FDA.
 
Principal Deputy Commissioner Dr. Amy Abernethy to Leave FDA. Dr. Abernethy, who was also the acting Chief Information Officer, will leave the agency to return to the private sector. She was the driving force behind the FDA’s Fall 2019 Technology Modernization Action Plan (TMAP) (here) and the recently released Data Modernization Action Plan (DMAP) (here). In response to a media inquiry, the Alliance stated:

FDA’s greatest challenge is to have information technology and data integration systems to keep pace with the acceleration of scientific knowledge and support effective, timely and complex agency decisions and actions. Dr. Abernethy’s leadership has brought the agency to the point at which substantially increased investment, which is essential, will maximize the benefit to the agency and the American public.

FDA Blog: Status Report on Inspections. In an FDA Voices column (here), Acting Commissioner Janet Woodcock and Associate Commissioner for Regulatory Affairs Judy McMeekin describe the impact of the pandemic on FDA food and medical product inspections and the agency’s evolving approach to assuring safety. They discuss new technologies and tools that are being used, including “remote livestreaming video of operations, teleconferences or screen sharing.” They will be working with the industry to integrate these approaches into future efforts.

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