Gottlieb Steps Down at FDA

The Trump administration is now searching for a new FDA commissioner thanks to the news that Scott Gottlieb is resigning from the post after only two years, citing his desire to spend more time with his Connecticut-based family. Gottlieb will stay on the job for another month, but this announcement comes only two months after Gottlieb quashed rumors of his intention to leave the FDA.

Gottlieb was at the helm of the agency as controversies over device approvals and inspections of overseas makers of active pharmaceutical ingredients roiled the media, but he also experienced success as a staunch supporter of expanding drug access via generic drug approvals as well as pushing the FDA digital health agenda forward. He may be remembered foremost for his dedication to the public health in reducing vaping and tobacco use by teens.

The obvious question is whether the White House will nominate someone of a similarly modest bent where regulation is concerned. Gottlieb’s tenure at the American Enterprise Institute and his skepticism regarding the FDA’s handling of commercial speech controversies won him no applause from some quarters. However, along with Gottlieb on Trump’s short list for the FDA job was Paypal co-founder Peter Thiel, who was seen as having a stronger anti-regulatory animus than Gottlieb and dangerous views regarding the role of the free market in supplanting FDA’s oversight.

It seems likely that Trump will nominate someone with a temperament similar to Gottlieb’s, although the Republicans retaining control of the Senate in the 2018 mid-term elections does allow the White House greater leeway. Whether drug and device makers will cheer the news of Gottlieb’s successor remains to be seen. Gottlieb took on the pharmaceutical industry with the release of a list of drugs that are off-patent as a way to foster generic drug development, part of the agency’s efforts to put a lid on drug prices, but he might also have played a significant role in development of legislation for the agency’s regulation of lab-developed tests. At the very least, the news portends significant disruption at the FDA, even if the agency’s policy compass holds to its current orientation.

 

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