Senate Confirms Scott Gottlieb, MD, as FDA Chief


May 09, 2017

Scott Gottlieb, MD, won Senate confirmation today to become the next commissioner of the US Food and Drug Administration (FDA) and one of the Trump administration's point persons for government deregulation.

A handful of Senate Democrats sided with the Republican majority to give Dr Gottlieb a comfortable 57-42 margin of victory.

For Dr Gottlieb's critics, however, the question remains whether his extensive ties to drug and medical device makers will influence the FDA's vetting process of new products. Dr Gottlieb has promised to put public health first and not do anything "that shakes the public's confidence in the agency."

By anyone's standards, Dr Gottlieb brings an impressive resume to his new job. He is a former hospitalist who served in the FDA during the George W. Bush administration, lastly as its deputy commissioner for medical and scientific affairs. He has sharpened his healthcare policy ax as a resident fellow at the American Enterprise Institute, a conservative-leaning think-tank in Washington, DC, and shared his views as a contributor to publications such as Health Affairs and the Wall Street Journal. His supporters note that as someone who has recovered from Hodgkin's lymphoma, Dr Gottlieb has a bona fide patient's perspective on the healthcare system.

Senate Republicans view his experience in the private sector as another strength. Dr Gottlieb has served as a board director or advisor to a long list of drug and medical device companies, including GlaxoSmithKline, Glytec, and Tolero Pharmaceuticals. He also has been a managing director of an investment banking firm that specializes in healthcare and a venture partner in a venture capital company that has placed bets in this industry.

To avoid any possible conflict of interest, Dr Gottlieb had promised that if confirmed, he would resign from a dozen current industry positions, sell off his investments in healthcare companies, and recuse himself from any FDA decisions relating to some 20 companies and institutions for 1 year. His plan passed muster with the US Office of Government Ethics.

Many Senate Democrats, however, opposed his nomination on the grounds that he could not lead the FDA in an unbiased fashion. One problem they see is his enforcement of new agency regulations for e-cigarettes. Dr Gottlieb owns stock worth less than $15,000 in Kure, a company that makes and distributes vaping products, and he served on its board from March 2015 to May 2016, according to documents filed with the Office of Government Ethics. His promise to recuse himself from decisions involving Kure extends 1 year past his resignation from the board.

The Campaign for Tobacco-Free Kids wants Dr Gottlieb to recuse himself from FDA deliberations on any matter pertaining to e-cigarettes in the future.

Follow Robert Lowes on Twitter @LowesRobert


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