Gottlieb resigns from FDA

Active Two Years

Scott Gottlieb, commissioner of the U.S. Food and Drug Administration (FDA), has announced his resignation. There is much speculation on why the 46-year-old physician, former venture capitalist and drug consultant left and how his active legacy will continue. Formerly a key FDA official during the George W. Bush administration, he was a healthcare investor and consultant who sat on multiple company boards.

President Donald Trump, who appointed Gottlieb to his post, tweeted, ”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!”

Health and Human Services Secretary Alex Azar said, “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. …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.”

Gottlieb saw drug approvals climb sharply from 22 in 2016 to 59 new drugs in 2018. Last year, the FDA approved a record 971 generic drugs. He attempted to take steps to stop escalating drug prices.

Tackling tough public health issues from youth vaping to opioid addiction, Gottlieb passionately promoted the FDA, getting it involved into critical health issues and sometimes taking issue with industries regulated by the FDA. He is credited with modernizing the process for handling novel gene and precision therapies made from living cells to treat those with cancer and other significant diseases.

Gottlieb’s youth vaping plan was designed to sharply restrict the sale of flavored e-cigarettes to curb a surge in underage vaping. Calling teen vaping “an epidemic,” he proposed limiting sales of most flavored e-cigarettes to age-restricted stores, or parts of stores, and greatly restricting online purchases. Gottlieb also developed a wide-ranging tobacco blueprint calling for reduced nicotine levels in cigarettes.

Last week, Gottlieb challenged 15 retailers including Walgreens Boots Alliance, Kroger Co and Walmart Inc , for illegally selling tobacco products to children. Last month, the FDA took action against some Walgreen and Circle K locations.

Gottlieb was concerned about the opioid epidemic. He got the FDA to remove the opioid medication Opana ER from the market, but the agency approved Dsuvia, a powerful new opioid.

With bipartisan support for protecting public health while stimulating medical product development, Gottlieb was behind the FDA Center for Devices and Radiological Health Medical Device Safety Action Plan to encourage post-market surveillance, real-world data collection and cybersecurity efforts. There was also increased scrutiny of controversial devices such as transvaginal mesh and breast implants. Gottlieb championed the ramping up of the FDA’s Pre-Cert Program to update the review of software as a medical device amid the rise of wearables and other hybrid products, while achieving the clearance of a record number of medical devices in 2017 and 2018.

“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,” Azar said.

Following news of Gottlieb’s resignation, the Nasdaq Biotechnology Index turned negative. He will leave the FDA with widespread backing from drugmakers and admiration for his efforts at transparency from industry critics.

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