FDA Commissioner Scott Gottlieb Resigns

Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, resigned on Tuesday. He will officially step down in about a month.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA. He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family,” said Department of Health and Human Services (HHS) Secretary Alex Azar, in a statement.

https://twitter.com/SGottliebFDA/status/1103168063510319104

“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. The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”

According to a report from The Washington Post, Dr. Gottlieb is stepping down to spend more time with his family.

All of us at @HHSGov are proud of the remarkable work @SGottliebFDA has done at FDA. The public health of our country is better off for the work the @US_FDA team has done over the last two years, and I will personally miss working with Scott. pic.twitter.com/EoUPTjkeJW

— Alex Azar (@SecAzar) March 5, 2019

“It was a very hard decision,” he told The Post in an interview. “This is the best job I will ever have. I’m leaving because I need to spend time with my family. I get home late Friday, work on weekends and come back to Washington on Sunday. I did the job 100 percent.”

Dr. Gottlieb had been commuting from his Connecticut home to Washington for work, according to The Post report.

Very sad to see @SGottliebFDA stepping down, the most effective @US_FDA Commissioner in decadeshttps://t.co/pRVWilYFNp

— Eric Topol (@EricTopol) March 5, 2019

During his time as FDA commissioner, Dr. Gottlieb advocated strongly against e-cigarette use in minors, calling the issue an “epidemic.” In September the FDA announced a crackdown on the manufacturers, calling the action “the largest coordinated tobacco compliance effort in FDA’s history.”

“This may require these brands to revise their sales and marketing practices, including online sales; to stop distributing their products to retailers who sell to kids; and to remove some or all of their flavored e-cig products from the market until they receive premarket authorization and otherwise meet applicable requirements,” Dr. Gottlieb said at the time.

In December the FDA revealed new measures to advance the development of biosimilars. Dr. Gottlieb wrote in a letter, “Not all parts of the pharmaceutical market have been equally open to competition from more affordable products.”

Breaking News: The head of the FDA, Scott Gottlieb, is resigning. He pushed for tougher regulation of e-cigarette and tobacco firms. https://t.co/1xR4RcawHQ

— The New York Times (@nytimes) March 5, 2019

“This is especially true for biologic medicines, which are … increasingly the backbone of modern therapy.”

….Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!

— Donald J. Trump (@realDonaldTrump) March 5, 2019