Tag: Association for Accessible Medicines

Scott Gottlieb steps down from US FDA leadership

 Volume 393, Number 10176      

 16 March 2019       

 

WORLD REPORT   The announcement came as a surprise, prompting many to ask: Can the US FDA commissioner’s policies continue without him? Susan Jaffe reports.

Unlike some government agencies that can toil peaceably in relative obscurity, the FDA is frequently in the headlines. It is responsible for ensuring the safety of products that account for about 20 cents of every dollar US consumers spend—or US$2·5 trillion annually.  …When Gottlieb became commissioner in 2017, the agency had an estimated 1000 vacancies which has now risen to 1400.[Continued here.]
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Scott Gottlieb sworn in to head the FDA

lancet cover 2Volume 389, Number  10084 

27 May 2017 

WORLD REPORT    Scott Gottlieb becomes commissioner of the FDA, as the agency’s role is threatened by an administration adverse to regulation.  Susan Jaffe, The Lancet’s Washington correspondent, reports.

Only 6 months ago, Scott Gottlieb was still a resident fellow at the American Enterprise Institute, a conservative thinktank, when he presented testimony to a US Senate committee investigating prescription drug prices. Before he began, he volunteered that he was “a reformed government bureaucrat, having worked at FDA [US Food and Drug Administration] for a number of years”. He blamed astonishing price hikes—500% in the case of Mylan’s EpiPen—on “regulatory failures stemming from FDA policy, and I think that policy can be fixed”.

Gottlieb was sworn in as the 23rd commissioner of the FDA after being approved earlier this month by the US Senate, over the strong objections of most Democrats. Now Gottlieb will have a chance to fix a daunting array of policies. [Continued here] …