Leadership and FDA Appropriation for FY 22

Q: When Will a New FDA Commissioner Be Named?A: Anybody’s guess. For reference, Dr. Hamburg in 2009 and Dr. Gottlieb in 2017 were both nominated in March and confirmed in May. In both of those instances, Acting Commissioners served successfully. Having Dr. Woodcock as Acting Commissioner this time assures the agency will not miss a beat until a Commissioner is nominated and confirmed.Q: What do we know so far about how budget and appropriations decisions will be made this year?A: Not much. Majority Leader Schumer and Minority Leader McConnell are still negotiating the ground rules for managing the 50-50 division in the Senate. In 2001, a prior instance of 50-50, there were an equal number of Democrats and Republicans on each committee and equal split of staff resources. Other than confirmation hearings, there doesn’t seem much the Senate can do until the new ground rules are set.In 2017, President Trump produced a broad budget plan in March and the customary detailed President’s Request in May. Undoubtedly, the new Administration would like to have a detailed budget request sooner and with monies allocated to its priorities. However, allegedly, the Transition Team was not given access to prior work that had been done on the President’s budget request. It is unclear how fast the Biden Administration can pull a budget request together if they didn’t have access to documents until this week.Meantime, Democrats are discussing how major programs can be enacted through budget reconciliation legislation. In the Senate, that process requires only 50 votes plus the Vice President and cannot be filibustered. During the first two years of President Trump’s term, this was the process used to enact major tax reform and other items.Q: Why is the elevation of OSTP to cabinet-rank and the appointment of Dr. Lander important for FDA?A: The White House Office of Science and Technology Policy (OSTP) was created in 1977 and has played larger and smaller roles in different administrations. Elevating the Director to Cabinet-level status is the strongest possible signal that the new administration is committed to science and scientific expertise. This is also evident in the five areas on which President Biden has directed OSTP to focus (here).Further, according to The Scientist (here), Dr. Eric Lander, the nominee for Director of OSTP, is the first biologist to hold this position. He is well-acquainted with FDA and understands its strengths and challenges. He arrives already knowing that FDA is a science agency -- something that might not have been clear to some of his predecessors. For those interested, here is Dr. Lander's keynote address at the 2017 FDA Science Forum.Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.