The White House confirmed that former FDA deputy commissioner Scott Gottlieb has been selected by US President Donald Trump to lead the agency. Mr. Gottlieb, who served in several senior positions at the FDA under the administration of former President George W. Bush, has spoken about reducing the cost of prescription drugs by modernizing the agency's approval process and hastening the availability of generic alternatives.
During his time at the FDA, Mr. Gottlieb worked as deputy commissioner for medical and scientific affairs and coordinated with the White House and Department of Health and Human Services. His duties included facilitating discussions that led to a system under which generic drugmakers paid to speed the review of their products, in line with the system used for brand-name drugs. Mr. Gottlieb must be confirmed by the Senate before he assumes his new role at the FDA.
"Thank God it's Gottlieb," remarked Robert W. Baird analyst Brian Skorney, adding "we view this as a favourable development for the sector." Mr. Gottlieb has served on GlaxoSmithKline's R&D board since 2010 after having previously been a member of its oncology board. He currently advises Bristol-Myers Squibb on its cancer drugs, and worked in an advisory capacity with Vertex Pharmaceuticals from 2009 through 2016. Mr. Gottlieb also holds seats on the board of directors of Daiichi Sankyo and Tolero Pharmaceuticals.
Commenting on Mr. Gottlieb, Ellen Sigal, founder and chair of Friends of Cancer Research, remarked "throughout his career, including his time at the agency, Scott has shown that he has the skills necessary to continue to lead the FDA to be patient-centred and science-focused." In addition, National Coalition on Health Care president John Rother said Gottlieb is "smart and knows the FDA and the issues."
However, Michael Carome, director of Public Citizen's Health Research Group, argued Mr. Gottlieb is "entangled in a web of Big Pharma ties," adding that his appointment "would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients."
Earlier this year, Joseph Gulfo, a former CEO of drug and medical device companies, confirmed that he had held discussions with Trump regarding being named FDA commissioner. There has also been speculation that Trump was considering Silicon Valley investor Jim O'Neill and biotechnology executive Balaji Srinivasan for the post.