It has been six months since Scott Gottlieb announced that he would be resigning as commissioner of the US Food & Drug Administration, and there is still no formal nominee to succeed him.

That is likely to change soon: under federal law governing vacancies for Senate confirmed positions, an agency can only be led by an “acting” for a maximum of 210 days before a nomination is made (or someone else is put in the acting role). That deadline is approaching at the start of November, and all indications are that the White House will make a formal nomination before then.

In the interim, former National Cancer Institute Director Ned Sharpless continues to lead the agency as acting commissioner, a post he formally took at the start of April. (Also see “New Acting US FDA Commissioner Shares Agency’s Clinical Trial Reform Message” – Pink Sheet, 12 Mar, 2019.)

Because Sharpless came on board as – in effect – Gottlieb’s hand-picked successor, it was easy to overlook how unusual it was for an outsider to step in to lead the agency on an interim basis. However, as the months have passed, Sharpless’ role has looked less and less like a simple transition to a new commissioner, and more like a very public audition. (Also see “Acting Normal: US FDA’s Unusual Interim Period Drags On” – Pink Sheet, 18 Jul, 2019.)

The public reviews have been very positive. Both within FDA and among its many external stakeholders, Sharpless is credited with maintaining the generally positive overall dynamics at FDA that defined Gottlieb’s tenure.

He has also received the formal endorsement of four of his other predecessors as commissioner: Andrew Von Eschenbach, Mark McClellan, Margaret Hamburg and Robert Califf. They joined in a letter to the White House urging Shrapless get the nomination.

(Gottlieb remains an advocate for Sharpless as well, but did not sign the letter to avoid running afoul of rules regarding lobbying after leaving the executive branch.) (Also see “Former Commissioners Push For Sharpless Nomination, Confirmation” – Pink Sheet, 4 Sep, 2019.)

However, the letter was not just sent to the White House, it was also shared with the Washington Post, along with another letter from cancer advocacy groups including Friends of Cancer Research. That suggests a perceived need to rally broader support for Sharpless, a form of public campaigning that would seem unnecessary if a formal nomination is already in the works.

Stephan Hahn On The Shortlist
As if on cue, the release of those letters was followed by the public identification of a different, external candidate for the job: MD Anderson Chief Medical Executive Stephen Hahn. The emergence of a new name as a finalist for the commissioner job underscores how tenuous Sharpless’ position is. Not only does it confirm that the White House is continuing to look at other candidates, it also suggests that Sharpless is not the only oncologist under consideration.

Hahn is a radiation oncologist who spent most of his career at the University of Pennsylvania before moving to MD Anderson in 2015 as head of its radiation oncology department. He joined the MD Anderson leadership team during a difficult period that included substantial financial shortfalls that emerged in 2016.

Hahn was named deputy president and chief operating officer at the start of 2017 as part of the turnaround plan put in place by then-president Ron DePhino. However, DePhino resigned in March 2017; Hahn continued in the COO role, with diagnostic radiology chief Marshall Hicks named interim president. Once MD Anderson selected Peter Pisters as its new president, Hahn was given the chief medical executive title.

Hahn’s undergraduate degree is from Rice and his medical degree is from Temple. He did his residency and clinical fellowship at NCI.

The Other Candidates
Hahn becomes the third alternative candidate to reach the public “trial balloon” stage of the vetting process. The other two were Assistant Secretary for Health Brett Giroir and Harvard dermatology professor Alexa Boer Kimball.

Giroir was considered a potential interim commissioner following Gottlieb’s departure – and indeed was described as HHS Secretary Alex Azar’s preferred choice for the role. He is already in a Senate-confirmed position as Assistant Secretary for Health and has played a prominent role in high profile White House issues like the opioid response. However, his involvement in thornier topics like fetal tissue research regulation and abortion funding restrictions would likely mean a partisan fight for confirmation as FDA commissioner, and indications are that he is no longer in the running.

Kimball is apparently still on the short list, though the long lag time between the initial floating of her name in June and the looming deadline for a nomination suggests she is not the front-runner. Kimball’s medical specialty (including a background in psoriasis drug research) does at least bring something different to the position compared to Sharpless’ oncology background.

Logically, the path of least resistance for the White House would seem to be to move forward with Sharpless as the nominee, and there is certainly every possibility that will be the outcome. At this point, however, the only thing that is clear is that Sharpless’ audition will be ending soon – and he hasn’t won the part just yet.

https://pink.pharmaintelligence.informa.com/PS140791/US-FDA-Commissione…