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FDA Commissioner Scott Gottlieb, MD, Resigns


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Scott Gottlieb, MD

Scott Gottlieb, MD

ON MARCH 5, 2019, Scott Gottlieb, MD, announced his resignation as Commissioner of the U.S. Food and Drug Administration (FDA), a post he began in 2017. Dr. Gottlieb’s resignation will be effective in April.

In a resignation letter to Alex M. Azar II, Secretary of Health and Human Services (HHS), Dr. Gottlieb outlined some of the highlights of his work as Commissioner:

In the last 2 years, the FDA set out to advance major new policies to reduce the morbidity associated with tobacco use; to confront teen use of e-cigarettes; to decrease the rate of new opioid addiction; to improve access to affordable generic drugs; [and] to modernize the development process for novel medical technologies like gene therapy and targeted medicines…. We advanced new approaches for the modern and efficient regulation of cell-based regenerative medicine, complex generics, targeted cancer drugs…, digital health tools, [and] personal genetic tests. We forged a new breakthrough pathway for novel devices that promote safety and undertook historic modernizations of the 510(k) process. We expanded opportunities for patients with terminal illness to access investigative medicines.

Dr. Gottlieb also pointed out that the agency “approved a record number of generic medicines, novel drugs, and novel devices in 2017” and that in 2018, the agency “topped our own achievements with new records.”

Mr. Azar issued a statement about Dr. Gottlieb’s service to the FDA in light of his resignation:

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. 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.

On Twitter, Dr. Gottlieb added: “I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together…. This has been a wonderful journey, and parting is very hard.”

On March 12, 2019, Mr. Azar appointed Norman E. Sharpless, MD, to be the FDA Acting Commissioner.


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