Gottlieb out as FDA commissioner two months after denying departure

Biopharma's opinion of Scott Gottlieb’s as US FDA commissioner was made plain after the news on Tuesday afternoon that he was resigning from the post. Both the Nasdaq biotechnology and S&P pharma indices fell after Mr Gottlieb, previously a scholar with the American Enterprise Institute and a venture capitalist, confirmed media reports that he would depart in a month. After emphatically denying rumours about his departure the move came as a surprise; no reason was given, although the Washington Post cited sources saying he wanted to spend time more time with his family. The resignation is not likely to affect normal operations like drug approvals or regulatory drafting, but biopharma had appreciated Mr Gottlieb’s desire to speed reviews of innovative agents and generics, the former helping the cause of gene and cell therapies and the latter aiming to improve price competition. Mr Gottlieb was chosen over two Silicon Valley entrepreneurs with little pharma background, and there could be fear among investors that President Donald Trump will seek as a replacement outsiders who will upend the normal functioning of the FDA. Another fear is that, after a period of relative leniency, his successor will raise the bar for drug approvals.

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