FDA Commissioner Scott Gottlieb to step down

Health and Human Services Secretary (HHS) Alex Azar on Tuesday announced that FDA Commissioner Scott Gottlieb is resigning from his post and will step down next month. "[Gottlieb's] leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction…[and] chronic disease," Azar said

Gottlieb was nominated by US President Donald Trump to head the agency in 2017 and later confirmed by the US Senate. He had previously served as a deputy agency commissioner under the administration of President George W. Bush. Commenting on his resignation, Trump said Gottlieb "has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!"

The news comes after Gottlieb denied speculation earlier this year that he was considering leaving the agency, although an administration official familiar with the situation indicated that the move has been in the works for several months. Gottlieb said "it was a very hard decision," adding "I'm leaving because I need to spend time with my family." A senior FDA official noted that Gottlieb is stepping down on amicable terms, although a source close to the matter suggested that Gottlieb had been frustrated by the government shutdown earlier this year that halted a number of agency tasks.

Under Gottlieb's tenure, the agency introduced proposals targeting drug pricing and competition in the pharmaceutical sector. He has also announced measures to hasten the authorisation of complex generic drugs and speed the availability of biosimilars. More recently, Gottlieb announced plans to boost the number of FDA clinical reviewers who oversee the clinical investigation, development and review of cell and gene therapy products ahead of an anticipated increase in such filings for agency approval.

Meanwhile, the number of novel therapies approved by the FDA jumped to 59 in 2018, versus 22 in 2016, while a record 971 generic drugs were cleared by the agency last year. For related analysis, see ViewPoints: Gottlieb begins his long goodbye.

Names that have been put forward as possible successors to Gottlieb include Norman Sharpless, director of the National Cancer Institute, and Brett Giroir, assistant secretary at HHS.

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