FDA Commissioner Scott Gottlieb Stepping Down

By Patricia Van Arnum - DCAT Editorial Director

March 7, 2019

US Food and Drug Administration Commissioner Scott Gottlieb has announced that he will be leaving his post in the next month. He made the announcement on March 5 (2019) and cited family commitments as the reason for his departure.

“This is a very special institution, and the work that binds us in a shared mission is inspiring,” Gottlieb wrote in a letter to his staff, in which he posted on Twitter. “I know that the opportunity to serve in this role was a privilege, and an endeavor that I’ll never be able to replicate in my professional life—the impact of our public health work, the camaraderie and our ability to improve the lives of Americans.”

Gottlieb was nominated by Commissioner by President Donald Trump in March 2017 and confirmed by the US Senate and took the helm of the FDA in May 2017.

In leading the FDA, Gottlieb returned to the agency where he served as Deputy Commissioner for Medical and Scientific Affairs following his appointment in 2005. He is a physician and previously served as a resident fellow at the American Enterprise Institute and as a venture partner at New Enterprise Associates, a Chevy Chase, Maryland-headquartered venture capital firm.

In his letter to staff, Gottlieb said that he will be working in the coming weeks to help secure the FDA’s 2020 budget and transition the agency to new leadership. Gottlieb said that he will be working closely with the Secretary of Health and Human Services (HHS) Alex Azar, whom Gottlieb called a “staunch advocate for the agency.”

Azar also recognized Gottlieb’s contribution to the agency. “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,” said HHS Secretary Azar in a March 5, 2019 statement. “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.”

A successor has not been named. President Trump, who will nominate the next FDA Commissioner, said Gottlieb will leave government service sometime next month and said that he has done “an absolutely terrific job” as FDA Commissioner, in remarks made on March 5, 2019 on Twitter

Gottlieb’s tenure as FDA Commissioner has been an active one with key policy initiatives, such as the Drug Competition Action Plan, a plan to address the cost of prescription drugs by increasing drug competition by improving the process for generic-drug development, review, and approval. He also continued earlier agency policy to advance continuous manufacturing and other new technologies to support innovation in drug development and manufacturing. He will also leave the agency with a high of 59 new molecular entities (NMEs) approved in 2018, surpassing the previous record of 53 NME approvals in 1996 and the 46 NMEs approved in 2017.

Source: US Department of Health and Human Services