FDA chief Scott Gottlieb to step down

The FDA’s commissioner Scott Gottlieb has announced he is to leave the post, after less than two years in the role.

Gottlieb confirmed the news yesterday, after having previously denied rumours of his departure which had surfaced two months ago.

The news has nevertheless come as a surprise to the pharma and biotech sectors, where Gottlieb has been viewed as a great success since being appointed by President Trump in 2017.

There had been concerns that Gottlieb would align himself with Trump’s wild promises to cut away FDA oversight and regulation, but sceptics were won round by his energetic but well-targeted programme of change at the agency.

Gottlieb’s reputation has remained high in the pharma and biotech sectors, thanks to his championing of faster, streamlined drug approvals, which helped the FDA to achieve two consecutive record-breaking years for approvals of new drugs.

However he also pushed the agency to achieve similar record approvals for generics, and made it clear this was part of a push to help address high drug prices and a lack of competition in the US market – an unprecedented stance for an FDA commissioner.

FDA officials have confirmed to the media that the departure had been in the planning for several months, and that he was stepping down for purely personal reasons. Gottlieb has been commuting weekly to Washington from his home in Connecticut and wants to spend more time with his young family.

Speaking of his pride in having led the agency, he said: “There is perhaps nothing that could pull me away from this role other than the challenge of being apart from my family and missing my wife and three young children.”

The announcement was swiftly followed by heartfelt praise from President Trump and health secretary Alex Azar, with whom Gottlieb had worked closely on issues such as the opioid crisis and efforts to address drug competition.

The latter included a ‘name and shame’ list of companies which abused regulations to block generic and biosimilar competition.

Despite taking on pharma market abuses, Gottlieb’s championing of faster approvals, closer working with the industry and new dedicated pathways for digital innovation and cell and gene therapy won the admiration of a pharma and US healthcare leaders.

Harvard University professor and FDA expert Daniel Carpenter told the AP news agency Gottlieb had been in a minority of successful appointments by President Trump.

"He could govern from a place of moderation and get all the more credit because so many other agencies and positions under the Trump administration were either falling apart or vacant," said Carpenter.

Gottlieb has been forceful in his opposition to the rise of vaping products, but was widely criticised for recently delaying regulations on vaping devices until 2022, a move aimed at not over-regulating the new sector.

Biotech investor and Twitter stalwart Brad Loncar was quick to laud Gottlieb’s short record in office, but also voice some concerns about a potential delay to finding a successor.