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Advocacy at a Glance

January 16, 2021

Top-Line: Congressional organizing, impeachment, inauguration, and COVID-19 planning are all part of changes in DC. This week’s Analysis and Commentary examines our gratitude for Congressional leaders who have supported increased funding for FDA. President-elect Biden’s Phase One COVID-19 plan emphasizes vaccination distribution and holding the economy together.

Congress Organizes: Much Different But Some Parts the Same. Here are some of the relevant bits relating to the new Congress and the new Administration:

  • There will be 12 new Members of the House Appropriations Committee (6 Democrats and 6 Republicans), but subcommittee assignments have not been released.
  • After Inauguration Day, the Senate will be divided 50-50 with Vice President-elect Harris casting the tie-breaking vote for the Democrats to organize as the majority party.
  • This 50-50 tie last happened 20 years ago and is discussed by Roll Call here. While the past is instructive, it is not yet known how issues like committee ratios, staffing, etc., will be decided in the Senate this time.
  • It has been widely reported, but not confirmed, that Dr. Janet Woodcock will serve as Acting Commissioner until a new Commissioner is confirmed.
  • We hear the same rumors as everyone else about possible nominees for Commissioner. As in the past, the Alliance urges speedy naming and confirmation of a new Commissioner, but takes no position for or against specific candidates for the post.
  • According to Politico, the Senate has received the financial disclosure and other materials for HHS Secretary-Designate Xavier Becerra, but no pre-Inauguration confirmation hearing is expected.

Congressional Support for FDA: Much to Be Grateful For. As part of the FY 21 appropriations bill enacted in December, FDA received a $42 million increase. The agency 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).

The essential element of FDA progress is Congressional support for increased agency funding. Our thanks are due 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 this week’s Analysis and Commentary.

President-Elect Biden’s Phase 1 COVID-19 Proposal. Yesterday evening (January 14), President-elect Biden released his American Rescue Plan (here). While it cites the importance of accelerating vaccines, diagnostics, and therapies, the overwhelming focus is on fixing the broken system of COVID-19 testing and vaccination, as well as proposing important steps to keep individuals and businesses afloat and to re-open schools and workplaces. Meantime, within 2 hours of the proposal’s release, Representative Jason Smith, Ranking Member of the House Budget Committee, criticized the plan as overly broad and a vehicle for Democratic policies not related to addressing COVID-19.

Former FDA Commissioner David Kessler to Leading Role in Operation Warp Speed. As announced by President-elect Biden and reported by the New York Times (here), former FDA Commissioner David Kessler has been appointed to be the Chief Science Officer of Biden’s COVID Response team, which is also known as Operation Warp Speed (here). OWS is the primary vehicle for: (1) stimulating development of new medical countermeasure products to combat COVID-19 and (2) coordinating purchasing and distribution. It has gotten high marks for its support of vaccine development, but has been criticized for the slow pace of Americans having access to vaccinations.

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