Dr Scott Gottlieb to Resign as FDA Commissioner

FDA Commissioner Scott Gottlieb, MD, will resign his post in about a month. The physician, who has been active in fighting youth e-cigarette use, encouraging generic drug competition, and modernizing approval processes, wants to spend more time with his family.

In a note to colleagues shared on the FDA’s Twitter account, Gottlieb announced his decision and expressed optimism for the future of the FDA.

“There’s perhaps 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 three young children,” wrote Gottlieb, who commutes between Washington, DC, and his family’s home in Connecticut.

“I’ll depart knowing that the FDA is strong, its people outstanding, and its mission well recognized and deeply respected across the government, and indeed, across the world,” he continued. “I consider myself truly fortunate to have had the chance to help lead this remarkable institution.”

In a statement, HHS Secretary Alex Azar praised Gottlieb’s work.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA. He has been 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. The public health of our country is better off for the work Scott and the entire FDA team have done over the last 2 years.”

As recently as January 3, 2019, Gottlieb shot down speculation that he would leave the FDA. “I want to be very clear—I'm not leaving. We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon,” he tweeted.

Gotllieb’s initial nomination to head the agency was met with criticism from some groups like Public Citizen, which warned that his past pharmaceutical industry ties might present a conflict of interest. His tenure, however, has received praise from both sides of the aisle, particularly his work on bipartisan priorities like battling the opioid crisis, stopping teen vaping, and restructuring the drug review process.

On his watch, the FDA made progress in spurring competition and driving down drug prices by expediting approvals of generic drugs, according to a recent report. More than 1000 generic drugs were approved or tentatively approved in 2018, and almost 1 in 10 approvals that year were generics that were the first approved competitors to branded drugs.

Speeding generics to the market had been a priority of Gottlieb since the first months of his role as commissioner. When the FDA’s Drug Competition Action Plan was announced in June 2017, he described expedited generic review as a component of an array of upcoming steps to accomplish the goal of ensuring patients’ access to drugs.

“Getting safe and effective generic products to market in an efficient way, being risk-based in our own work, and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options,” he said in that statement.

The roadblocks to competition he mentioned were another target of scrutiny under Gottlieb, who called on drug makers to “end the shenanigans” that keep competitors off the marketplace by taking advantage of safety regulations called risk evaluation and mitigation strategies (REMS) programs, according to The Center for Biosimilars^®, a sister site of The American Journal of Managed Care^®.

“Negotiations to reach agreement on shared system REMS can take extended periods of time. This can block the timely entry of a generic competitor,” said Gottlieb at the time. “I believe branded firms sometimes use these negotiations strategically, as a way to slow generic competitors.”

Perhaps his signature issue, however, was curbing the skyrocketing rates of vaping among teenagers. “These data shock my conscience,” Gottlieb said of the 78% increase in high school students using e-cigarettes between 2017 and 2018, when he announced the FDA’s plans to restrict sales of flavored e-cigarettes in November 2018.

The day before his resignation was announced, Gottlieb issued a statement castigating retailers like Walgreens that continue to illegally sell e-cigarettes to underaged buyers. He also noted that the FDA has sent letters to more than 40 companies to probe about the legality of its marketing practices for e-cigarette products.

Gottlieb stated that future policy updates would be forthcoming. “[If] these trends of youth e-cigarette use persist, we’ll be forced to consider regulatory steps that could constrain or even foreclose some of the opportunities for currently addicted adult smokers to have the same level of access to these products in order to protect youth,” he wrote.

Once news of his resignation broke, Ted Okon, executive director of the Community Oncology Alliance (COA), expressed his dismay, tweeting, "Say it ain't so." He later added in a statement that COA was "truly saddened" to learn that Gottlieb was leaving.

“The diversity of issues Commissioner Gottlieb tackled—including drug approvals, opioids, e-cigarettes/vaping, and more—and the modernization of the FDA were amazing," he said in a statement. "During his brief tenure at the FDA, Dr Gottlieb had to also deal with natural disasters and a government shutdown. His leadership will be sorely missed, and Dr Gottlieb will be difficult to replace.”

CMS Administrator Seema Verma also issued a statement praising his service, saying, "Scott has been both a great leader as FDA Commissioner 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. I join the entire HHS family in thanking him for his service."