Reports: Makary out, Diamantas in as FDA commissioner
Dr. Martin Makary has resigned from the FDA rather than be let go, according to multiple media reports citing unnamed government sources. Politico first reported the news. Kyle Diamantas, who currently serves as the agency's top food regulator, will serve as acting commissioner.
It's not yet clear why Makary got the axe, though Politico's source says it was Health Secretary Robert F. Kennedy Jr. who made the call. After the Wall Street Journal reported rumours of the change late last week, there was speculation that it was Makary's clash with Trump over flavoured vapes that was at issue.
However, with reports that the order came from HHS, it seems more likely it was related to the long-simmering tension between Makary and Kennedy. Last fall, Politico reported that the two were at loggerheads over FDA vaccine policy as well as some personnel issues.
A Johns Hopkins surgeon and writer with controversial views on COVID policy, Makary was considered one of Trump's less controversial appointees when he was confirmed last fall with a 56-to-44 vote that included three Democrats. Since then he's been in the difficult position of enacting the agendas of both President Trump, with his focus on lowering drug prices and increasing access to experimental treatments, and Secretary Kennedy, with his focus on upending vaccine policy and increasing scrutiny on food.
But Makary's own agenda has been one of progress and efficiency: His tenure saw the introduction of the controversial Commissioner's National Priority Voucher which has dramatically reduced approval times for a handful of high-profile drugs; the rapid deployment of the ELSA AI tool for speeding up scientific review; and he was just beginning a pilot for realtime clinical trial reporting.
“We have got to try new things,” he told BIO President John Crowley in a fireside chat last year. “We are seeing an increasingly competitive landscape internationally. We are seeing prolonged time and wasted steps result in a lack of investment, we are seeing companies get frustrated. … So we're going to continue to look at everything we can do to challenge the deeply-held assumption that it does take 10 years for a new drug to come to market.”
Makary also oversaw the beginnings of a crackdown on pharmaceutical advertising though the actual impact of that action has been fairly limited.
The traditional number two position at the FDA, Principal Deputy Commissioner, has been vacant since Dr Sara Brenner moved into a Senior Counselor position at HHS on April 16th. As a result there isn't an obvious candidate for Acting Commissioner. Diamantas, a former Partner at Jones Day and a friend and hunting buddy of Donald Trump Jr., has a slim resumé even for his current job, but its unclear what experience if any he has with drugs and medical devices.
