Gottlieb resigned from his position at the US Food and Drug Administration (FDA) in March 2019 after two years in the role. A spokesperson for Pfizer told us that the company approached Gottlieb in April 2019 after his resignation from the FDA.
According to a report from the Washington Post at the time of his resignation, Gottlieb stated he was leaving the position to spend more time with his family.
During his time as commissioner, Gottlieb fought against opioids and took action on the opioid epidemic by approving therapies for opioid withdrawal and cracking down on opioid manufacturers - Pfizer is an opioid drug maker and produces the pain medicine Embeda (morphine/naltrexone). Pfizer, however, is also currently developing tanezumab, a non-opioid pain drug, with Eli Lilly & Co.
Under his leadership, the FDA in 2018 approved 1,021 abbreviated new drug applications and published more than 250 new or revised guidances. The agency also launched an online function for controlled correspondence, responded to 7,000 inquiries, and issued 2,659 complete response letters.
Albert Bourla, CEO of Pfizer, said in a statement, “Through his work as a physician and his time at the FDA, Scott has continually demonstrated an understanding of both patients’ needs and the rapidly changing dynamics of biopharmaceutical research and development.”
Currently, Gottlieb is a special partner of New Enterprise Associations, a health care investment team, and serves as a resident fellow of the American Enterprise Institute.
Before he served as FDA commissioner Gottlieb held roles in both the public and private sector. He served as the FDA’s deputy commissioner for medical and scientific affairs and as a senior adviser to the administrator of the Centers for Medicare and Medicaid services.
Ned Sharpless became Acting Commissioner of the FDA on April 5, 2019 after Gottlieb’s resignation. Sharpless was previously the director of the National Cancer Institute, and the director of the University of North Carolina’s Lineberger Comprehensive Cancer Center.
