firstwordpharmaMarch 13, 2017
According to people familiar with the matter, former FDA deputy commissioner Scott Gottlieb is the top choice of US President Donald Trump to lead the agency, several news outlets reported Friday. One of the people indicated that Gottlieb is still being vetted, although some sources suggested that an announcement regarding his nomination could come as early as Friday.
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 modernising the agency's approval process and hastening the availability of generic alternatives.
During his time at the FDA, 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.
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. Gottlieb also holds seats on the board of directors of Daiichi Sankyo and Tolero Pharmaceuticals.
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Commenting on the speculation, 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 Gottlieb is "entangled in a web of Big Pharma ties," adding that his confirmation "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.
Trump has pledged to streamline the approval of drugs by the FDA, terming the current process "slow and burdensome." The President previously expressed plans to work to lower drug prices.
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