Q&A on impact of FY 23 Appropriations Cycle on FDA; The Alliance’s statement on commissioner vacancies.

Q: If the FY 22 appropriations bills are completed by March 11, what are the likely impacts on FDA for both FY 22 and FY 23.
A: For the FY 22 cycle, the House supported a $257 million increase in BA for FDA. The comparable number from the Senate Appropriations Committee bill was an increase of $200 million. How much FDA receives will depend, in part, on how much the Ag/FDA Appropriations Subcommittees are given to spend under the current negotiations.

For FY 22, FDA will have less than 7 months to implement all its new initiatives, address backlogs created by pandemic work and the late arrival of funds, make sure staff needs are met, and assure critical personnel decisions are made. We often talk about how CR’s wreak havoc with program and personnel planning.

The FY 22 funding levels are based on FDA’s needs last summer and FDA will need to gain further ground when the President’s FY 23 budget is released. FDA’s workload continues to grow at a rapid pace—additional responsibilities from Congress, increased complexity of science, globalization of the food and medical markets, and unplanned but urgent public health needs.

Q: Is it common for there to be a year-long gap between Senate-confirmed FDA Commissioners?
A: Yes. The first Commissioner to be confirmed was Dr. Kessler in 1990. Of the eight commissioners since his time, half were sworn in more than a year after their predecessor left the agency (Drs. Henney, McClellan, Crawford, and von Eschenbach). Two more fall into a seven-to-ten-month range (Dr. Califf in his first confirmation, and Dr. Hahn). The remaining two (Drs. Hamburg and Gottlieb) were both nominated in March and sworn in by May. https://www.fda.gov/about-fda/fda-leadership-1907-today/commissioners.

Almost the entirety of those delays occurred between the departure of a commissioner and the nomination of a new one. As I recollect, once nominated, the confirmation process has typically taken about two to four months.

Q: What has been the Alliance’s position on the selection of new Commissioners?
A: Because we have a broad-based membership, with diverse interests, we have never advocated for any specific person to be nominated and confirmed. Instead, our consistent position over the last 15 years has been to urge “quick nomination and quick confirmation.”

Rereading the history (as described in the prior question), it is easy to see why the Alliance would take the position we have. All FDA stakeholders need to be concerned that FDA is so often left without a permanent, Senate-confirmed Commissioner.

Reflecting this view of the institutional problem, the Alliance released the following statement last week:

"In the current environment, it's hard to overstate the importance of Senate-confirmed leadership at the FDA. We implore the Senate to move with urgency and confirm a new FDA commissioner."

In the same vein, Alliance Executive Director Steven Grossman was quoted by Associated Press this week:
“It is troubling to see Dr. Califf judged on issues that are a very small part of the FDA’s responsibilities. This narrow focus increases the likelihood there will be more and longer periods when FDA is without permanent leadership.”

Who leads FDA is important, but it is just as important that competent, well-prepared candidates be able to take on the role of permanent Senate-confirmed Commissioner soon after the position falls vacant.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.