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It’s About the Journey and the Destination

Hot Topics | January 22nd, 2021

Last week security concerns led President Biden to scuttle his plans to travel to Washington, DC for Inauguration Day via Amtrak. That being said, there was little question Biden would be at the U.S. Capitol on the morning of January 20 to be sworn in as the 46th president of the United States.

The same cannot be said for George Washington. Though our nation’s first president had a reputation as a wealthy man, he was what 18th century society referred to as “land-poor.” Despite owning his valuable 500 acre Mount Vernon estate, Washington had few liquid funds. In order to pay for his journey to New York City (the capital of the U.S. in 1789) for his inauguration, Washington had to borrow £600 at 6% interest.

Who’s in and who’s out

  • In: Former FDA Commissioner David Kessler was tapped to serve as chief science officer of the COVID-19 response effort (which will no longer be called Operation Warp Speed). 
  • In: If confirmed by the Senate as the Assistant Secretary of Health and Human Services, Dr. Rachel Levine would become the first openly transgender Senate-confirmed federal official. (The HillAssociated Press D.C. Bureau)
  • In: Eric Lander was nominated to serve as President Biden’s science advisor and director of the Office of Science and Technology Policy. (STAT
  • In: Janet Woodcock, Director of Center for Drug Evaluation and Research, has been tapped to lead the FDA on an interim basis. (The Wall Street Journal)
    • Out: Dr. Stephen Hahn, who told POLITICO on his way out that COVID-19 created a “clash of cultures” between the FDA and the White House. (POLITICO)
  • Out: Surgeon General Dr. Jerome Adams resigned his post at the request of Joe Biden this week. (The Washington Post)

Changes to healthcare policy on Day 1

  • Biden’s Chief of Staff Ron Klain issued a regulatory freeze memo which will halt a number of last minute Trump administration regulations governing FDA authority over medical devices, changes to certain Medicare drug coverage rules and consent requirements for researchers working with tissue from aborted fetuses. (STAT)
  • Roll Call and POLITICO published roundups of the new administration’s executive orders on healthcare, which among other things, created the office of COVID-19 response coordinator, required masks to be worn on all federal properties and reversed the U.S. withdrawal from the World Health Organization.

COVID: Priority number 1

  • It’s clear that COVID is the top priority of Democrats in Washington. This week the American public got a first look at President Biden’s COVID-19 strategy, which notably promises 100 million doses of COVID-19 vaccines administered in 100 days. (The HillThe Washington Post). Meanwhile, Speaker Nancy Pelosi said that the House will move immediately to pass another COVID-19 relief package. (The Hill)

It’s not all Biden news

  • Talks between the FDA and industry continue on the reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII will be in effect FY 2023 through FY 2027. There are several subgroups meeting to align on their priorities for this legislation including finance, post-market, manufacturing and inspections, and digital health and informatics. Expect more updates in the coming months. (Regulatory Focus)

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