Scott Gottlieb confirmed as FDA Commissioner

Takes reins with prior experience at both FDA and HHS

Scott Gottlieb has been confirmed as FDA Commissioner by the US Senate in a 57-42 vote, mostly along party lines. He takes over from Robert Califf, who had been confirmed to that post in February 2016, and who resigned the day the Trump administration took over.

Gottlieb’s nomination had significant criticism from Senate Democrats, worried about Gottlieb’s close ties to the pharma industry. He has announced that he would recuse himself from decisions on companies with which he had previous work. According to a Wall St. Journal article, this will involve some 20 pharma companies. The Journal also reported, based on the nominee’s disclosures, that he had earned $645,000 in consulting with pharma companies and trade groups in the 14 months prior to his nomination.

In congratulating Gottlieb, Jim Greenwood, CEO of the BIO organization, said “We are confident that Dr. Gottlieb’s confirmation will provide the agency with the stability and leadership needed to fully harness the tools of modern drug development and to better incorporate patients’ perspectives into the agency’s regulatory processes.”

Gottlieb’s prior experience includes deputy commissioner for medical and scientific affairs at FDA (2005-7) and advisory work for HHS as the Medicare Modernization Act was implemented in the early 2000s. He trained as a medical doctor, and is also a survivor of Hodgkins lymphoma.