FDA Commissioner Scott Gottlieb Announces Resignation

FDA Commissioner Scott Gottlieb, MD, on Tuesday announced in a letter to colleagues that he plans to resign from his post within the next month, just short of two years after he was confirmed for the position by the Senate.

Gottlieb said in the coming weeks, he will work to finalize the FDA’s budget for 2020, and he’ll also assist Secretary of Health and Human Services Alex Azar in transitioning the agency to its next leader. Azar praised Gottlieb’s work in a statement released by HHS on Tuesday.

“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,” Azar said in the statement. “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’s work in addressing the opioid crisis has been widely lauded. Last week, the FDA released a statement from Gottlieb in which the commissioner called the opioid epidemic “one of the largest and most complex public health tragedies that our nation has ever faced” and “the biggest public health crisis facing the FDA.”

In the statement, Gottlieb outlined additional actions being pursued by the FDA in 2019, including: reducing avoidable exposure to opioid analgesics, requiring manufacturers to develop disposal technologies for unused medications, prioritizing new efforts to advance the development and use of safe and effective medication-assisted treatment for opioid addiction, improving access to over-the-counter naloxone, researching non-addictive pain treatments, and strengthening enforcement against illicit opioids.

Prior to becoming FDA commissioner, Gottlieb worked in the private sector from 2007 to 2017, and his ties to the pharmaceutical industry were an area of concern for some Democrats in Congress. But during his tenure, Gottlieb criticized brand-name drug makers and pushed for faster approvals for generic drugs, according to the Washington Post. The FDA approved 971 generic drugs in 2018 alone.

Gottlieb has also pushed to lower nicotine in cigarettes and advocated for policies to limit vaping among teens.

On Twitter, President Donald Trump said Gottlieb “has done an absolutely terrific job as Commissioner of the FDA.”

“…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!” Trump said in a tweet.