Despite Early Skepticism, FDA's Scott Gottlieb Won Wide Approval

The doctor and venture capitalist, who announced his resignation Tuesday as FDA commissioner, served nearly two years in the Trump administration.

After having served as Food and Drug Administration commissioner since the early months of the Trump administration, Scott Gottlieb, MD, plans to resign in about a month, the administration said Tuesday.

HHS Secretary Alex Azar released a short statement praising Gottlieb's accomplishments and confirming earlier press reports on the departure. Azar called Gottlieb "an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation."

"I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family," Azar said.

"Scott'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, tobacco and youth e-cigarette use, chronic disease, and more," Azar added. "The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years."

Azar's statement came after The Washington Post's Laurie McGinley and Lenny Bernstein published a 1,700-word story on Gottlieb's departure about 3 p.m., citing "an administration official." The story reported that Gottlieb, a wealthy venture capitalist, wishes to spend more time with his family, based in Westport, Connecticut.

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Gottlieb had as recently as two months ago sought to quash rumors that he would be departing the agency. "I'm not leaving," he wrote in a January tweet. "We've got a lot [of] important policy we'll advance this year. I look forward to sharing my 2019 strategic roadmap soon."

In a resignation letter published by Axios, Gottlieb said he's confident the FDA will continue to advance its ambitious goals after his departure.

Widely Respected, Despite Concerns
 

While some agency heads have prioritized the Trump administration's deregulatory agenda, Gottlieb has won approval for his active embrace of the FDA's authority.

"Commissioners come, and commissioners go, but Scott Gottlieb hands down has been the best," Richard Pazdur, director of the FDA's oncology center of excellence, told The Wall Street Journal's Thomas M. Burton and Jennifer Maloney.

Robert Califf, who was FDA commissioner during the Obama administration, told the Post that Gottlieb did "a great job."

One of his biggest accomplishments at the FDA was accelerating the approvals process for generic drugs while prioritizing cases involving steep prices and a lack of competition, as Bloomberg Opinion columnist Max Nisen wrote, adding that Gottlieb's departure means the Trump administration is "set to lose one of its most competent officials."

Not unlike Azar, Gottlieb's past ties to the pharmaceutical industry had critics worried he might go easy on drug makers and business interests in general. But many naysayers overlooked key attributes that set Gottlieb on a different path, including his penchant for frequent public pronouncements, Ed Silverman wrote for Stat News.

"Gottlieb never missed an opportunity to clearly signal what was going on at the FDA, a politically adept move that he hoped would give him a chance to shape policy rather than have new dictates imposed on him," Silverman wrote.

Centers for Medicare & Medicaid Services Administrator Seema Verma called Gottlieb "a great leader" and "a wonderful friend."

"I am honored and privileged to have had the opportunity to work alongside him and see all that he has accomplished for the American people to spur medical innovation, increase access to generic drugs, and advance many other public health priorities," Verma said in a statement. "I join the entire HHS family in thanking him for his service."

Editor's note: This story was updated Wednesday, March 6, 2019, with additional commentary.