Not quite two years into his stewardship of the FDA, Scott Gottlieb, M.D., is stepping down. His sudden departure will likely send shock waves through biopharma, because the commissioner was popular for his market-based policies to lower drug costs and work to speed new brands to approval.
Gottlieb won Senate confirmation as FDA commissioner back in May 2017, an uncertain time for the drug industry. During the selection process, his name had been favored by a majority of biopharma executives polled by an analyst. At the time, one anonymous executive said he's the "least likely to rail for the obliteration of the current efficacy, safety, risk-benefit model that is a foundation for advancement of new treatments in the United States"—unlike at least one other candidate for the job.
That preference proved out after Gottlieb took over the agency, as his policies favored speed and competition. And when the news broke Tuesday afternoon, the industry trade group PhRMA praised his "exemplary leadership."
"During his tenure, he focused on innovation in drug development and review, increased competition, and advanced the regulatory framework for approving novel technologies, including gene therapies," the organization said in a statement. "His efforts have made a meaningful impact for patients in need of innovative medicines.”
Gottlieb tweeted Tuesday that he's "immensely grateful" for the opportunity to lead the FDA. In a letter to colleagues, he wrote that "there’s nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and two young children."
President Donald Trump tweeted that he's done an "absolutely terrific job" and will be missed.
In his resignation letter, tweeted by STAT reporter Matthew Herper, Gottlieb reviewed his efforts at the agency over the past two years. It’s a long list, but here are a few examples: The FDA worked to avoid drug shortages after a hurricane struck Puerto Rico, led a global investigation into drug impurities, advanced reviews of cell and gene therapies, and bolstered approvals of complex generic drugs.
Also under his command, the FDA took quick and decisive action on drug costs. The commissioner worked to boost generic approvals and crack down on regulatory “gaming” that stifles competition. He additionally blamed branded drug companies for an "anemic" U.S. biosimilars market and recently blasted insulin pricing.
His sudden departure will likely leave many agency efforts to lower costs up in the air. After the news broke, many pharma watchers posted on Twitter that Gottlieb's resignation is a loss for the industry.
During his tenure as FDA commissioner, Gottlieb’s name had been floated for HHS chief when former HHS secretary Tom Price resigned due to a travel scandal, but Gottlieb said he was best suited for the FDA commissioner job. Now, former Eli Lilly executive Alex Azar serves as HHS secretary, and on Tuesday afternoon, Azar praised Gottlieb for his work at the agency.
Before working as FDA commissioner, Gottlieb served as a deputy FDA commissioner and a government health policy adviser, among other roles.
Gottlieb’s departure will also mark a setback to the Trump administration’s effort to lower drug costs. The administration in May released its “blueprint” to fight high drug costs, which aims to bolster competition in drug markets and lower out-of-pocket costs for patients.