A name familiar to the medical device industry has surfaced as a possible nominee to lead the FDA: the Trump administration is reportedly mulling Dr. Joseph Gulfo, the former CEO of Mela Sciences (now Strata Skin Sciences (NSDQ:SSKN)), for FDA commissioner.
Dr. Stephen Ostroff is leading the federal safety watchdog on an interim basis, after the resignation of Dr. Robert Califf Jan. 20 ahead of last week’s inauguration. 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.
Earlier this month venture capitalist Dr. Scott Gottlieb, an Obamacare foe who’s also a former deputy commissioner at the federal safety watchdog, emerging as the reported forerunner. Gottlieb, a fellow at the conservative American Enterprise Institute, is also an assistant professor at the New York University School of Medicine and a former practicing physician and hospitalist. At the FDA Gottlieb 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.
Now comes Gulfo, who’s 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.