Gottlieb Stepping Down as FDA Commissioner

FDA Commissioner Scott Gottlieb, MD, will be stepping down from his post in 1 month.

FDA Commissioner Scott Gottlieb, MD, will be stepping down from his post in 1 month. Since taking office, he has encouraged generic drug competition and the growth of biosimilars in the US healthcare system.

In a note to the FDA, Gottlieb explained that he was stepping down because of the time he has spent away from his wife and 3 young children.

"I know that the opportunity to serve in this role was a privelege, 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," he wrote. "There are many important efforts we undertook together, countless new policies we advanced, and laws we enforced with vigor to protect consumers."

He added that in his final weeks as commissioner, he will continue to cement the work he started and secure the 2020 budget.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” HHS Secretary Alex Azar said in a statement. “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.”

President Donald Trump sent out a tweet thanking Gottlieb for his work:

Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month....

— Donald J. Trump (@realDonaldTrump) March 5, 2019

Under Gottlieb, the FDA released in 2018 the Biosimilar Action Plan, which was meant to spur biosimilar competition. The plan addressed 4 key areas in order to spur biosimilar competition:

  • Improving the efficiency of the biosimilar and interchangeable product development and approval process
  • Maximizing scientific and regulatory clarity for the biosimilar product development community
  • Developing effective communications to improve understanding of biosimilars among patients, providers, and payers
  • Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products

In January 2019, Gottlieb outlined his goals for the year at the JP Morgan Healthcare Conference. These goals included bringing down drug prices through increased competition and a robust biosimilars market.

When Gottlieb was nominated to become FDA commissioner, he was met with scrutiny over his industry ties and his opposition to many regulations. Ultimately, he was confirmed mostly along party lines in a 57 to 42 vote.

"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 said. “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.”