Gottlieb has held several senior positions at the FDA during the George W. Bush administration, and has regularly spoken on plans to lower prescription drug cost through modernizing the federal watchdog’s approval process, according to the report.
Gottlieb serves as a fellow at the conservative American Enterprise Institute and as an assistant professor at the New York University School of Medicine. During his time at the FDA, he served as senior adviser for medical technology, director of medical policy development and deputy commissioner for medical & scientific affairs. Before that he was a senior policy adviser at the Centers for Medicare & Medicaid Services.
White House spokespersons have declined to comment on the pick, according to the Bloomberg report, and the nomination is still being vetted.
Gottlieb has been positioned as a forerunner for the position since January, alongside possible candidate Dr. Joseph Gulfo, former CEO of Mela Sciences (now Strata Skin Sciences (NSDQ:SSKN)).
Dr. Stephen Ostroff is leading the federal safety watchdog on an interim basis, after the resignation of Dr. Robert Califf Jan. 20. Early speculation had Jim O’Neill, a libertarian and Silicon Valley investor with no medical experience, as the leading candidate to replace Ostroff. O’Neill has made controversial statements about the federal safety watchdog, including in 2014 when he said that the agency should no longer evaluate whether medical devices or drugs are effective when considering them for approval. That statement was viewed harshly by experts, with some saying that it demonstrates how O’Neill’s lack of medical experience could be a problem. A medical background is usually considered a prerequisite for the position as FDA chair.
In January, it was reported that Gulfo had discussed the FDA gig with “at least 2 transition team officials and some of their outside advisers,” according to Stat News; he declined to discuss his candidacy, the website reported.
Gulfo spent more than 9 years at the helm of Mela Sciences before stepping down in June 2013, earned headlines as the company pursued FDA approval for the MelaFind system, a process that took more than 2 years, 2 FDA panel reviews and a citizens’ petition. Mela Sciences, and Gulfo, became something of a poster child for charges of unpredictability at the FDA during the prior decade.
Since leaving Mela Sciences, Gulfo has written a book about his experience getting MelaFind through the FDA and comments frequently about issues at the agency. He’s served as a senior fellow at both the left-leaning Progressive Policy Institute and the conservative Mercatus Center at George Mason University. He is executive director of the Lewis Center for Healthcare Innovation & Technology at Fairleigh Dickinson University.
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