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Advocacy at a Glance

January 22, 2021

Top-Line: Dr. Woodcock is the new Acting Commissioner. Alliance members and other FDA stakeholders are encouraged to express thanks to Congress for supporting FDA. Today’s Analysis and Commentary explores when a new Commissioner might be named, what we know so far about budget and appropriations this year, and how the White House Office of Science and Technology Policy is important to FDA.

Dr. Woodcock to Serve as Acting Commissioner. Until a Commissioner is named by the Biden Administration and confirmed by the Senate, FDA (like most federal agencies) will need an acting head. The administration has named Dr. Janet Woodcock, long-time FDA leader and universally-respected for her substantive knowledge and managerial skills, to take on the acting role. According to a number of news sources, she is also a candidate, among others, for appointment to the position on a permanent basis. Today’s Analysis and Commentary addresses a number of topical questions, such as: when will a new Commissioner be named?

Assignments for Appropriations Committees Still Pending. We are starting to see Member assignments released, but so far neither the House nor Senate have set rosters and leadership assignments for their appropriations committees. Those who had been Chairmen and those who had been Ranking Members are expected to flip positions in the Senate as a result of the new Democratic majority.

Saying Thanks to the Agency’s Champions in Congress. An essential element of FDA success is Congressional support for increased agency funding. Based on the passage of legislation at the end of December (here), FY 21 was a successful year for FDA funding. However, it was also a year in which demands on the agency increased enormously and seem likely to stay at these higher levels for the extended future. Our thanks are due to the Ag/FDA subcommittee leadership — Representatives Bishop and Fortenberry and Senators Hoeven and Merkley. The Alliance’s role in saying “thanks,” as well as what our Alliance members can do, is the topic of last week’s Analysis and Commentary (here). Please consider sending a letter of thanks … it definitely helps FDA’s cause.

Budget, Appropriations, and 2021 Politics. This year is a hard one to forecast. The start of an administration always brings new priorities and, also, opportunities for revisiting old processes of governing. For the new Biden team, there will be a lot of negotiating with Congress and the use of executive orders and budget reconciliation if those efforts fail. Compounding the uncertainties: Speaker Pelosi commands a smaller majority in the House and the Democratic Senate majority rests solely with the Vice President’s ability to break ties. Some of the possibilities are discussed in today’s Analysis and Commentary.

On behalf of the Alliance and its members, we will be tracking all these twists and turns. Our goal will be to identify situations that might impact on FDA’s mission and resource needs. In those instances, we will work to advocate for solutions that reflect the breadth and depth of FDA’s commitment to the American public. We will keep emphasizing our key message: FDA’s growing responsibilities require a budget that grows.

New Leadership Announced for the White House Office of Science and Technology Policy (OSTP). President Biden announced that the director of OSTP will be a Cabinet-level position. He also appointed Dr. Eric Lander, a prominent bio-scientist to head the Office. Dr. Lander is currently the President of the Broad Institute of MIT and Harvard. The implications for FDA are also discussed in this week’s Analysis and Commentary.

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