Scott Gottlieb and the credibility of U.S. therapeutics

New England Journal of Medicine

29 March 2017 - President Donald Trump has nominated Scott Gottlieb as U.S. Commissioner of Food and Drugs. 

The Trump administration’s approach to the FDA is guided by a libertarian belief in markets over science, and Gottlieb apparently shares this view. He has argued that the agency displays an “unreasonable hunger for statistical certainty” and a “profound lack of confidence in the ability of doctors to make careful judgments.” He seems poised to weaken phase 3 testing requirements. 

The administration considered nominees with even more extreme views, including the belief that the FDA should not be in the business of regulating drug efficacy.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation