Senate Confirms Dr. Gottlieb's Nomination as FDA Commissioner

Jones Day

On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate fills the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and was replaced in the interim by Dr. Stephen Ostroff. Dr. Gottlieb, a physician, policy analyst, and entrepreneur assured in his confirmation hearing he will make his mission "to fight for those families every single day, and ensure that FDA puts their interest first." Dr. Gottlieb also stressed he will lead the FDA as "an impartial and passionate advocate for public health" and offered to work for better efficiency and better safety while also remaining "faithful to FDA's gold standard for regulatory conduct."

Earlier, on April 27, 2017, the Senate Committee for Health, Education, Labor and Pensions ("HELP") voted 14-9 on Dr. Gottlieb's nomination. Accompanying the action by the HELP Committee, Sens. Sherrod Brown (D-OH), Maggie Hassan (D-NH), Edward J. Markey (D-MA), Elizabeth Warren (D-MA), and Sheldon Whitehouse (D-RI) sent a letter to Dr. Gottlieb requesting details about the nature of his work and financial relationship with the drug company Cephalon while at FDA previously, based on a recently published article which stressed that when he was Deputy Commissioner of the FDA Gottlieb "engaged with the DEA on behalf of…Cephalon to increase the amount of fentanyl available for it to manufacture its products."

Dr. Gottlieb has previously served in government in various capacities, including as deputy commissioner and as a senior official at the Centers for Medicare and Medicaid Services during the Bush Administration. Gottlieb, who stated he would divest his interests from any FDA-regulated companies where he currently holds a financial interest, is a venture partner at New Enterprise Associates, a clinical assistant professor at New York University School of Medicine, and has provided consulting services to several drug companies. For more information on Dr. Gottlieb's nomination, please see our Pharmaceutical and Medical Device Update Vol. IV. Issue 1.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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