Califf Sets Exit At FDA, Ostroff Could Return To Acting Commissioner Post
This article was originally published in The Rose Sheet
Executive Summary
Former acting commissioner in line for the temporary position again under FDA policy, unless incoming Trump administration designates someone else.
Robert Califf schedules the end of his comparatively brief time as FDA commissioner and it appears a familiar agency official might temporarily replace him.
Stephen Ostroff, deputy commissioner for foods and veterinary medicine, appears in line to become the acting commissioner, assuming Califf departs as scheduled and the incoming Trump administration does not designate someone else to run the agency in the short term. It was Ostroff who was the bridge between the end of Margaret Hamburg's tenure in April 2015 and Califf's confirmation in February 2016.
FDA said in an email to the Pink Sheet that Califf will leave the agency at noon on Inauguration Day, Jan. 20, as per presidential transition tradition.
FDA Commissioner Robert Califf steps down on Jan. 20, though he has said he would like to continue in the post under the Trump administration.
Office of Criminal Investigations Director George Karavetsos also has announced he will leave his post on Inauguration Day. (Also see "US FDA’s OCI Director Is Leaving For Private Practice" - Pink Sheet, 4 Jan, 2017.)
Typically, political appointees like Califf resign their positions when a new president is elected, but it is possible they could keep their jobs. although it is rare for a commissioner to survive a change in the White House. Califf was thought to have a chance because of his overwhelmingly bipartisan confirmation vote. (Also see "Califf Maintains Desire To Stay At FDA, But Would Either Presidential Candidate Keep Him?" - Pink Sheet, 5 Nov, 2016.)
Other political hires at the agency also likely will depart within the next few weeks. (Also see "Will US FDA Wind Up With More Political Positions Under Trump?" - Pink Sheet, 4 Dec, 2016.)
Trump has yet to announce his nominee for FDA commissioner. Former FDA official Scott Gottlieb, who was added to the Trump transition team, (Also see "Gottlieb Joins HHS Transition Team; Will Next Stop Be FDA?" - Pink Sheet, 1 Dec, 2016.) along with investment manager and former Department of Health and Human Services official Jim O'Neill have emerged as possibilities. (Also see "Possible Trump FDA Commish Candidate Favors (Much) Lighter Touch" - Pink Sheet, 8 Dec, 2016.)
The HHS employee directory lists Ostroff as acting commissioner, although it is unclear whether his entry has not been updated since he last held the acting commissioner title. Califf does not appear in the directory. Ostroff did not respond to a request for comment.
FVM Deputy Commissioner Next In Line
FDA policy indicates that Ostroff would take over for Califf unless Trump appoints someone else.
FDA's staff manual guide states that if the commissioner dies, resigns or is otherwise unable to perform the functions of the office, the Deputy Commissioner for Foods and Veterinary Medicine shall become acting commissioner unless the person does not meet the requirements under the Vacancies Reform Act or the president has designated another for the role.
Stephen Ostroff is expected to begin his second stint as acting FDA commissioner when Robert Califf leaves the post.
Ostroff took the deputy commissioner position when Califf became commissioner. (Also see "FDA Chief Scientist Post A Chance For Califf To Make Mark" - Pink Sheet, 1 Sep, 2016.)
Under the law, Ostroff can serve nearly a year. He is allowed up to 210 days, but if the vacancy exists during the 60-day period beginning on Inauguration Day – the day Califf will leave – the 210-day period does not begin for 90 days.
Stakeholders argue FDA works best with a confirmed commissioner. But there is some good news in that Ostroff has experience running the agency. He also may not be expected to make major changes during his second go-around in the top office.
When he took over following Hamburg's departure, Ostroff said he wanted to maintain FDA's current course, had no new priorities on his mind, and wanted to complete ongoing activities. (Also see "FDA Staying The Course Under Ostroff; Hamburg’s Concerns Will Remain Focus" - Pink Sheet, 20 Apr, 2015.)
Should Ostroff embrace a similar hands-off approach again, it may help soothe staff fears about the departures of Califf and others, as well as the possibility of major changes coming when Trump takes office. Office of New Drugs Director John Jenkins announced his retirement effective Jan. 6, and could be the one of several among the agency's senior leadership team in the coming years. (Also see "'Brilliant' and 'Steady' Jenkins Retiring From US FDA's Office of New Drugs" - Pink Sheet, 5 Dec, 2016.)
Center for Drug Evaluation and Research Director Janet Woodcock produced a video for staff suggesting they focus on their work instead of the uncertainty associated with the transition process. (Also see "Woodcock Tries To Calm US FDA Staff Fears About Trump" - Pink Sheet, 21 Dec, 2016.)
Ostroff also has experience navigating the appropriations process, which will be important with a new Congress beginning its work. (Also see "FDA Feels Heat On Drug Pricing And Generic Labeling Rule" - Pink Sheet, 25 Feb, 2016.) And he was not afraid to fight for agency funding while acting commissioner. Ostroff argued that the 21st Century Cures legislation, which at the time was still under consideration, could force cuts to other FDA programs if not properly funded. (Also see "FDA Program Cuts Loom If ‘Cures’ Bill Isn’t Fully Funded, Ostroff Warns" - Pink Sheet, 3 Jun, 2015.)
He also suggested at the start of the prescription drug user fee reauthorization process that the program may need to be reviewed to ensure all aspects of it are adding value. (Also see "Does PDUFA Need A Haircut? FDA Ponders Trimming Its Responsibilities" - Pink Sheet, 15 Jul, 2015.)
Califf's Short, Eventful Tenure
Califf's time at the FDA helm will last nearly 11 months if he leaves as scheduled; Ostroff could wind up spending more time in the position once his second stint ends.
Califf will be remembered partly for his focus on real-world evidence and its use for regulatory purposes. (Also see "Real World Evidence: ‘Hot Topic’ At US FDA, But Not On Front Burner" - Pink Sheet, 15 Dec, 2016.) He also worked to enhance FDA's expertise and staffing, including by connecting with outside experts to help ensure the agency remains on the cutting edge of science. (Also see "Califf Lowering FDA Drawbridge To Work With External Expertise" - Pink Sheet, 25 Apr, 2016.)
FDA also implemented its opioids action plan, intended to help fight abuse, under Califf's leadership. (Also see "Opioids And The Limits Of FDA Power" - Pink Sheet, 22 Mar, 2016.) Concerns about the agency’s opioid policy contributed to the delay in Califf’s Senate confirmation.
In addition, Califf played an interesting role in the controversial approval of Sarepta Therapeutics Inc.'s Duchenne muscular dystrophy drug Exondys 51 (eteplirsen). After CDER's review divisions decided against approval, Woodcock overruled them. FDA staff appealed the decision to Califf, who sided with the CDER director. (Also see "Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate" - Pink Sheet, 19 Sep, 2016.) He later said that he did not want to introduce political interference into the drug approval process. (Also see "Political Appointees Shouldn't Influence Approval Decisions, Califf Says" - Pink Sheet, 20 Oct, 2016.)
This article originally was published in The Pink Sheet.