Q&As About the upcoming appointment of a new FDA Commissioner

Q&As About the Appointment of a New FDA Commissioner

The Alliance fields questions every week from policymakers, media, and the public about FDA, its mission and responsibilities, and its resource needs. Sometimes those questions tend to cluster around a single topic, as they did this week. We kept being asked: when will the President nominate a permanent FDA Commissioner. Here is what we know:

Q: How Long Can Dr. Woodcock Stay Acting?
A: 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. 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.

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 falls vacant during the first 60 days after the inauguration. So, mid-November is the correct answer to “how long can Dr. Woodcock stay acting.” She can stay longer if she or someone else is nominated for the position pending Senate confirmation. If no one is nominated, then the Administration will need to appoint a new acting Commissioner.


Q: What is the White House Saying?
A: At a White House briefing this week, the press secretary was asked: Given the departure of Dr. Francis Collins, how quickly does the administration want to have his replacement in office? And do you have any update on the search for an FDA administrator?

This was answered: “So, that decision is expected to be made before Dr. Collins steps down, as far as the nominee for his position. I am not going to be making any — clearly, any announcements on a nominee from this gaggle here today. And in the meantime, the American people can rest assured that there is a strong leadership across NIH and the department management — managing the COVID-19 pandemic and more.

And so, as far as the FDA, the role of the FDA commissioner is critically important, as you all know, especially during the COVID-19 pandemic. We have strong acting leadership in place that is playing an important role in our COVID-19 response and beyond and look forward to sharing a nominee with the required expertise and leadership for this job. So, hopefully, we’ll have something soon to share.”

Q: Is There a Candidate in the Wings, Just Waiting to be Walked on Stage?
A: In about 6 weeks, the President will need to either nominate someone or appoint another acting commissioner. Since a lot of vetting is required for any Senate-confirmable position and especially for the more visible ones like FDA, then the White House must have one or two candidates already in the late stages or must already know that they will need to appoint a new acting commissioner.

Potential candidates whose names have appeared in public lists appear to fall into two camps: names that have been on lists since last spring and new names (since the Spring) that have been quickly followed by a denial from the individual that they are interested or available. If there is a candidate in the wings, a remarkably large number of people either do not know or are being incredibly tight-lipped.

In short, the clock is ticking but it seems impossible to know whether an announcement is forthcoming soon. The Alliance’s position—which we have held for many years through many changes of FDA leadership—is that we believe that the swift nomination and rapid confirmation of a permanent FDA commissioner is in the best interests of the agency and the public.

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