Who Will Lead the FDA Under the Trump Administration?

Two names are being floated as likely replacements for the current FDA commissioner: Scott Gottlieb, MD, a resident scholar with the American Enterprise Institute, and Jim O’Neill, a managing director at Mithril Capital, a global investment firm.

Confirmed in late February 2016 to lead the FDA, cardiologist Robert Califf, MD, the current FDA commissioner will likely have been in office for a year-and-a-half before he is replaced in 2017, once the new administration of President-elect Donald J. Trump takes charge.

Currently, 2 names are being floated as likely replacements for Califf: the first is Scott Gottlieb, MD, a resident scholar with the American Enterprise Institute, who has previously served as deputy commissioner of medical and scientific affairs at the FDA. The other name that has surfaced is Jim O’Neill, a managing director at Mithril Capital, a global investment firm, who is far removed from the characteristics of a typical candidate for this position—O’Neill has not been trained in the medical sciences and his career history includes stints within the education field, but also within HHS, where he served as senior adviser to the deputy secretary and as principal associate deputy secretary.

At The American Journal of Managed Care®’s Patient-Centered Oncology Care® meeting in November, Gottlieb addressed the biggest issue that is on everyone’s mind: will the new administration repeal the Affordable Care Act (ACA)? He believes that bits and pieces of the law will continue to exist, although under a different name, but the new government will ultimately look at replacing the ACA.

Expressing his views on the sky-rocketing drug prices, Gottlieb said that there is a need for policy changes to allow me-too drugs a more favorable entry path—and more competition—to help address concerns on drug prices. According to Gottlieb, regulatory processes for first-in-class drugs are much different from the follow-on drugs, which should change. In his opinion, market forces—not the government—should intervene in drug pricing, because government intervention would impede innovation. Gottlieb is currently a part of President-elect Trump’s transition team.

O’Neill, according to STAT News, is not thrilled with the structure and incentives within the FDA’s regulatory workflow. He has suggested in the past that the FDA should allow marketing of a drug once the sponsor has proved it is safe. “Let's prove efficacy after they’ve been legalized,” O’Neill was quoted as saying during a speech in 2014. This could add to the controversy that arose following the passage of the 21st Century Cures Act, with respect to speed of regulatory approval and its impact on drug product safety. The Act was overwhelmingly passed by the Senate. O’Neill’s candidacy has a strong backing from Peter Thiel who has been a donor to the Trump campaign and is also participating in shaping the new administration. Thiel is a cofounder of Mithril Capital.