Scott Gottlieb, FDA commissioner, resigns

Daniel Fowler
March 8, 2019

"He has been very engaged, and I think the industry has had a very good relationship with him; he has been working very constructively with everybody", one insider said.

Many public health advocates largely praised his plans to limit youth e-cigarette use but urged the FDA to do more. He served in the FDA under George W. Bush and then spent almost a decade as a conservative commentator at the American Enterprise Institute, while also working as a venture capitalist and industry consultant.

Biosimilar developers were in harmony with that assessment; the Biosimilars Council, a division of the Association for Accessible Medicines, told The Center for Biosimilars in an email that a "testament to his commitment to bringing more affordable generic and biosimilar medicines to patients are the record number of approvals seen during his tenure".

Richard Pazdur, director of oncology at the FDA, said in a glowing statement to the Wall Street Journal: 'Commissioners come, and commissioners go, but Scott Gottlieb hands down has been the best'.

"This includes the recent, reckless decision to approve the super-potent opioid, Dsuvia, and the withdrawal of a proposed rule that would have allowed generic drug companies to promptly update their labels with new warnings", Carome continued.

Analysts also highlighted that the tobacco products division of the FDA was "clearly moving down a path toward greater restrictions", particularly in regard to combustible products (i.e. normal cigarettes) and flavoured e-cigarettes.

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Under Gottlieb, the FDA issued a ban on the sale of fruit- and candy-flavored electronic cigarettes in convenience stores and gas stations, meaning only tobacco, mint and menthol flavors can be sold at these outlets. "But they were just proposals".

The departure of the high-profile regulator reverberated in the stock market. "We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cig usage/access, cig nicotine limits and a cig menthol ban given he was the champion behind these initiatives".

Judging by initial reactions from across the dietary supplements and food industries, Dr Gottlieb was a respected partner for business. "I want to be very clear - I'm not leaving", he wrote on Twitter on January 3.

Dr Gottlieb, who took the helm at the FDA in May 2017, will remain with the Agency for another month before stepping down.

"There are many important efforts we undertook together, countless new policies we advanced, and laws we enforced with vigor to protect consumers", he wrote. He had previously served the FDA as its deputy commissioner for medical and scientific affairs. But Gottlieb said the agency had a role to play and reshuffled its review procedures to speed up approvals of lower-cost generic drugs, with the aim of increasing competition in the marketplace.

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