More Q&As on the Status of Appropriations and the Nomination of a New FDA Commissioner

More Q&As on the Status of Appropriations and the Nomination of a New FDA Commissioner

Q: Apart from the need for an agreement on total federal discretionary funding for FY 22, what else is slowing progress on appropriations?
A: Congress has now approved a $480 billion increase in the national debt limit through December 3 - the same day as the expiration of the current Continuing Resolution. This is an extra reason to hope that a full-year appropriations bill for FDA will be completed before that date—as debt resolution involves yet another set of politics that could be disruptive. Meanwhile, both House and Senate face tough sledding moving forward on both the $1 trillion infrastructure bill and its far more controversial sister, the $3.5 trillion reconciliation bill.

Q: What is the current situation regarding possible White House action on the nomination of a new Commissioner?
A: Individuals appointed to be “acting” for a Senate-confirmable position are limited in their tenure. It is normally 210 days, but because Dr. Woodcock was appointed at the beginning of an Administration her term is longer, ending in mid-November. Thus, there is slightly more than 4 weeks for the President to either nominate someone or appoint another acting commissioner. If he nominates someone, Dr. Woodcock can remain acting through the confirmation of her successor.

It is this short timeframe that is prompting the daily press questions at the White House about when a nomination is forthcoming. In the last day, a Washington Post story has rapidly shifted attention to the prospect of President Biden nominating Dr. Robert Califf, a Duke researcher and former Commissioner. This may turn out to be true, but it is just speculation (as of late in the evening on October 14). The only individual and the only date that matter is when the President announces that he is sending a formal nomination to the Senate.

Assuming the White House intends to nominate someone before the mid-November deadline for appointment of a new “acting,” then the relatively lengthy White House vetting process also becomes a variable. A candidate must be well-advanced before an announcement of a nomination is likely to be made. In the case of Dr. Califf, there is no indication whether he emerged in the last few days or has already begun a vetting process. Or—important to emphasize—it may not be Dr. Califf at all.

Q: Once a nominee (Dr. Califf or someone else) is formally sent to the Senate, what comes next?
A. The Senate has its own vetting process, which includes, among other things, submission of a comprehensive financial disclosure by the nominee. This is then reviewed by Committee staff and there may be one or more rounds required for clarification and/or additional questions. The HELP Committee will then announce and hold a confirmation hearing. How quickly that occurs may be driven by the complexity of the vetting process and the Senate schedule. Once the confirmation process is complete, then Chair Patty Murray will schedule a committee mark-up to vote on forwarding the nominee to the Senate floor. Then a vote needs to be held in the Senate . Both the committee and floor votes may be affected by the Senate schedule.

The process described is variable in its length. Six to ten weeks would be a common timeframe. However, it can take a much longer or a much shorter time. The key point is that the Presidential nomination is the start of the process, not an indication of when the nominee will be sworn in and ready to lead. My recollection is that both Dr. Hamburg and Dr. Gottlieb were nominated sometime in March and confirmed sometime in May.

Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.