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CQ Roll Call – Ostroff Preparing to Take the Reins at FDA

CQ Roll Call – Ostroff Preparing to Take the Reins at FDA

Stephen Ostroff is likely to once again take over as acting commissioner of the Food and Drug Administration when the current commissioner, Robert Califf, leaves at the end of President Barack Obama’s administration, according to the agency’s staff manual guidebook.


President-elect Donald Trump’s transition team has had no contact with Califf, lobbyists say, and he is not expected to be asked to retain his position in the new administration. An agency spokeswoman declined to comment on Califf’s communication with the Trump team or on the FDA’s future leadership plans but pointed to the guidebook. Officials for Duke University, Califf’s employer prior to joining the FDA, did not immediately respond to questions regarding whether he will return to his previous position there.


The vetting of potential candidates will ramp up after Trump’s inauguration Jan. 20, say individuals with knowledge of the process. Current front-runners for the position are former FDA official Scott Gottlieb and Silicon Valley investor Jim O’Neill, lobbyists say. A spokesman for the Trump transition team did not respond to a request for comment.


Califf, who was overwhelmingly confirmed by the Senate in February 2016, is well-respected by both scientific and congressional leaders. Several pharmaceutical and medical device industry officials, along with patient and disease advocacy groups, have expressed hope in interviews with CQ Roll Call over the past few months that Trump would keep Califf on into the next administration.


“He’s made a substantial impact in a short time, but of course he needs more time,” Ellen Sigal, founder of the nonprofit Friends of Cancer Research, said in a recent interview. “He came in during a very challenging time with a lot of things that were very difficult to manage and handle, so I think he comes out feeling very proud about what he accomplished.”


The FDA has several major initiatives on its agenda in 2017. Congress is expected to soon begin work on the reauthorization of several user fee agreements between the agency and industry that fund almost half the FDA’s activities. The current agreements expire later this year. The agency must also begin implementation of the “21st Century Cures” biomedical innovation package (PL 114-255) that was signed into law late last year.


“This year is an incredibly complex year,” Sigal said. “If you look at all the things that have to be done, it’s pretty daunting.”


Califf’s departure is also expected to trigger additional senior-level vacancies. Lobbyists say Rachel Sherman, deputy commissioner for medical products and tobacco, is preparing to leave as well. Sherman returned to the agency in 2015 at the request of Califf. She responded to a CQ Roll Call inquiry by referring the question to an FDA spokeswoman who did not immediately respond.


Ostroff previously served as acting commissioner following the departure of former commissioner Margaret Hamburg in 2015.