Scott Gottlieb Resigns from FDA

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Washington, D.C.—Scott Gottlieb, commissioner of the Food and Drug Administration, announced his resignation, effective in April. The announcement came at the start or Expo West, causing much buzz and speculation as to what had led to the resignation—and what the impact would be for the natural products industry.

The New York Times quoted Dr. Gottlieb as saying that he was weary of the commute—his wife and three children live in Westport, Connecticut—and that he missed his family. The Times further said that he had been “subject to increasing pressure from some Republicans in Congress and his former associates in the conservative movement, for his tough stance against youth vaping and traditional cigarettes.” That said, the Times quoted Dr. Gottlieb saying “There’s no intrigue here,” and that said pressure had no role in his departure.

The Chicago Tribune noted that the resignation was not sought by the White House, and that it came as a surprise to some FDA officials because “he was aggressively pushing a host of new initiatives.” The Tribune added that Dr. Gottlieb’s resignation letter listed his accomplishments: accelerating the approval of generic drugs, modernizing the process for handling novel gene and precision therapies, and the work the agency did in Puerto Rico regarding drug and medical device shortages after Hurricane Maria.

NPR quoted a statement from Health and Human Services secretary Alex Azar: “Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more.”

Dr. Gottlieb said in a tweet: “I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of @SecAzar and @realDonaldTrump—This has been a wonderful journey and parting is very hard.”

Those in the Industry had hoped that Dr. Gottlieb would work with the Industry to legalize cannabidiol in food and supplements—particularly given that the legal status is causing confusion in state governments and law enforcement—and were waiting for further information regarding the Dietary Supplements Working Group. The most recent news was that Gottlieb planned to discuss a legislative path to legalizing cannabidiol with Congress.

Steve Mister, president & CEO of CRN, said, “CRN thanks Dr. Gottlieb for his leadership and his engagement with the dietary supplement industry. We have been encouraged by Commissioner Gottlieb’s willingness to work with responsible players in the dietary supplement industry and his acknowledgment of the value of dietary supplements in supporting Americans’ health and wellness. CRN will continue to work with FDA leadership on key issues such as a legal pathway for hemp-derived CBD; NDI guidance; certificates of free sale—and more. We look forward to a prompt appointment and confirmation of a new commissioner.”

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