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Legal Limitations on Appointment of New FDA Commissioner

April 3, 2021

Nearly every recent conversation about FDA either begins or ends with, “What have you heard about the nomination of a new Commissioner?” In this regard, we have heard bits of speculation, but nothing that purports to be anything more than that. President Biden and Secretary Becerra’s plans are as opaque to us as they appear to be to the rest of the stakeholder community. 
 
Historically, FDA has been blessed with strong and talented acting commissioners — as it is now. Given the widespread respect for Dr. Woodcock, there are some in the stakeholder community who would be fine if the current situation were to continue indefinitely. However, there are two reasons why that cannot happen.
 
First, no matter how capable and worthy the Acting Commissioner, that person cannot fulfill indefinitely one of the most important responsibilities of the position. Only a Presidentially-nominated and Senate-confirmed FDA Commissioner can stand behind long-term commitments to the President, the Secretary, Congress, FDA staff, and the American people. Inherently, an official in an acting capacity cannot do that.
 
That does not preclude an individual from serving in an acting capacity and then being nominated for the post. In such a case, it can reasonably be expected that their leadership would be stronger once confirmation occurs.
 
Second, there are legal limitations on how long an individual can be acting in a Senate-confirmable role. The governing statute is the Federal Vacancies Reform Act of 1998 (here). This limits an acting to 210 days (slightly under seven months). Most of us became familiar with this restriction when Dr. Sharpless served as Acting Commissioner until the law required him to be replaced or a nominee named. This was an issue 15 years ago during the time that Dr. Lester Crawford was acting. The GAO violation letter is here.
 
Using the 210-day timeline, Dr. Woodcock could only continue until mid- to late-August unless she or another individual has been nominated to the post. In that case, she would be able to remain until she or someone else is confirmed.
 
However, the 1998 law recognizes that even 210 days might not be sufficient during a Presidential transition. It allows an additional 90 days (above the 210) if the vacancy existed at the time of inauguration or fell vacant during the first 60 days after the inauguration.
 
Under the 210 day plus 90-day timeline, Dr. Woodcock could continue to mid-November unless she or another individual has been nominated to the post. In that case, she would be able to remain until she or someone else is confirmed.
 
It seems very unlikely that the administration would let that amount of time go by without nominating a commissioner. From the Alliance’s standpoint — we urge speedy nomination and confirmation but back no specific candidates. It would be most regrettable for this position to continue to remain vacant. FDA’s work is too important, every day and for all Americans, for much additional time to pass without Dr. Woodcock or some other candidate being nominated. 
 
For those interested in a longer discussion of the Federal Vacancies Reform Act and its implications for the new administration, there is an excellent explanation from the American Constitution Society (here).

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

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