T he suddenly leaves the departure of Scott Gottlieb, Commissioner for the Food and Drug Administration, a gigantic hole at the top of an agency that monitors a quarter of the US economy. Which of course leads to an equally big question: Who will replace him?
This is actually a two-part question. First, the administration will probably decide on a working commissioner, who can take control when Gottlieb departs for a month. Then it becomes more difficult to find a nominee that can be confirmed by the Senate. It would not be exceptional for an administration facing other strokes to leave the actor in place for months –
"I have expressed my thoughts privately and I want to keep them private. I think there are some good people who are going to act," Gottlieb said on a Wednesday event as was arranged by The Hill. "When it comes to a nominee who is obviously a longer process, and I don't think they're about to make decisions about it yet. But I think who's in favor of filling the role in a working capacity is some good names in the mix. "
So who's stepping in? Who knows. But we are happy to fill the speculation vacuum. We have broken the list below into three main groups: the likely competitors, the "possible" picks and the complete wild cards.
Candidates (at least for the time being)
Abernethy, former chief executive of the Flatiron Health health agency, now part of Roche, became Gottlieb's second in-chief in early this year. In a note to investors, analysts at Cowen call her "the probable temporary leader." Abernethy was taken aboard to rethink how the FDA handles the data streams flowing from new digital approaches to medicine. As a researcher, she used data from electronic medical records to show that oxygen containers might not help patients with shortness of breath and helped create a computer network with the American Society of Clinical Oncology. At Duke, where she spent her academic career, former FDA commissioner Robert Califf was a mentor. When Abernethy's role in the FDA was announced, Gottlieb praised "her intellect, her passion for patient care and science, and her collegiality."
Her short duration could work against her, which she could lack experience in other areas the FDA regulates, such as blood products. On the other hand, she is basically the most important commissioner.
Sharpless, director of the National Cancer Institutions since October 2017, would bring deep knowledge of biotechnology to an FDA stint. Sharpless has previously run the University of North Carolina's Lineberger Comprehensive Cancer Center, where he was a physician, runs a laboratory and treats patients. He was, and is known as a believer by virtue of large data, to accelerate drug research by streamlining clinical trials. He co-founded two-clinical stage biotechs: G1 Therapeutics, a developer of cancer drugs that raised $ 108.6 million in a 2017 first public offering, and Healthspan Diagnostics, a blood sample developer. UNC colleagues remember him as someone "who had bold visions and turned them over to people to do a good job of executing," one said. "He trusts the people he hires to do a good job." He has been an enthusiastic baker (via Twitter) of Gottlieb's work on tobacco and e-cigarettes.
Grioir, the current HHS assistant health secretary, controls many of the boxes commonly requested by an FDA commissioner. Most notably: He has experience in government, academia and industry. The babysitter's professor turned biotechnology-start-up CEO's agent has led much of the HHS opioid work in Trump's administration – work that obviously dovetails with it from an FDA commissioner.
But his tenure in the Trump administration went off to a particularly rocky start after the Democrats became worried that he would be partisan on the issue of women's health, a problem in an agency where the controversy over making Plan Bp pills over -counter still raw, years later. He was a national college debate champion, so you know his confirmation hearings would be a hoot.
It may happen …
Woodcock, who heads the FDA's Center for Drug Evaluation and Research, is a strong figure in the agency where she has worked since 1986. She is also skilled at to testify to Capitol Hill – a necessary talent when the Democrats keep the house. Besides being a standing regulator, she was educated as a chemist and has a medical degree and it has meant that her name is almost always mentioned when a new FDA commissioner is needed.
But over the past two years, Woodcock has been working on a new organization and improvements for the FDA's core business. Cowen analysts speculated that finishing these efforts could mark a moment for her to retire. It is also worth noting that commissioners, who are political employees, have not previously been recruited from the FDA career staff.
McClellan not only acted as FDA Commissioner under George W. Bush, he also ran the Medicare and Medicaid Services Centers. His credentials make him a shoe-in for the job, should it be offered to him. McClellan may also be the only person in Washington who can compete with Gottlieb's enthusiasm when talking about the strange interaction between biosimilar and drug discount. And while McClellan is still pumping ideas on how to reform the FDA and reducing health costs as part of his current role at Duke University, he has largely gone from the limelight as Gottlieb, his former deputy, the hell agency. But did anyone who already drove both the FDA and the CMS really want their old job back, two decades later?
As Gottlieb, Adams, the surgeon in general, is another Trump administration figure popular in public health circles. (There aren't many.) He and Gottlieb also share some of the same health concerns, namely the use of youth's e-cigarette and addiction. But unlike Gottlieb, Adam's previous experience with the FDA or the broader drug development world is lacking. Prior to being appointed surgeon by President Trump, Adams was an anesthetist and then the Health Commissioner of Indiana (currently Gov. Mike Pence).
His nomination feels unlikely, partly because Adams seems to enjoy traveling to shore and highlighting his priorities, including the importance of carrying opioid overdose drug naloxone and the link between public health and the economy. But one thing to keep in mind: While Adam's role gives him a pretty prominent pulpit to talk about, it's basically just that. Running the FDA comes with a lot of regulatory power.
We admit it. Anything can happen.
Neill has, like Gottlieb, experience in the Department of Health and Human Services. He is a former HHS assistant assistant secretary. But, unlike the outgoing FDA commissioner, he seems to have little interest in how the agency traditionally works. Instead, Neill is a solid libertarian who has said that the FDA should not require drug companies to prove new drugs before they approve them. As long as treatments are safe, claims Neill in 2014, patients should be able to use them at their own risk. He has no medical training or scientific expertise, but he is aligned with billionaire investor Peter Thiel, who was Trump's adviser back in 2016 when O&L was on the list of FDA commissioners. Before Gottlieb was nominated, O'Neill's name was afraid of industrial insiders who feared it might be too much deregulation. Expect a similar reaction if it flatters again.
Gulfo discovered as a potential nominee back in 2016, while proposing extensive changes in how the FDA regulates drugs and medical devices, partly based on their own experience as chief executive of a diagnostic startup. Gulfo has in a number of publications and speeches prepared a four-tier system for the approval of new drugs, the highest being reserved for drugs that have shown lasting benefits to patients, while the lowest will apply to therapies that have only shown hints on efficacy. As he claimed, incentives to drug companies would gradually prove the long-term promise of their products while physicians and patients could decide themselves in the meantime. Gulfo, a member of the faculty at Fairleigh Dickinson University, has previously expressed his admiration for Trump despite a number of retweets of statements criticizing the president. These posts were made wrong, Gulfo said.
Matthew Herper, Ed Silverman, Damian Garde, Sharon Begley, Nicholas Florko and Andrew Joseph contributed to this report.