WASHINGTON (Reuters)—U.S. Food and Drug Administration (FDA) Chief Scott Gottlieb said he plans to step down in a month, calling into question how the agency will handle critical issues, such as e-cigarette use among teens and efforts to increase competition in prescription drugs.
The U.S. Department of Health and Human Services (HHS), which oversees the FDA, announced Mr. Gottlieb’s resignation on Tuesday, March 5.
Mr. Gottlieb was well regarded and won bipartisan support for his efforts to curb the use of flavored e-cigarettes by youths, speed approval times for cheap generic medicines to increase competition and bring down prescription drug prices and boost the use of cheaper versions of expensive biotech medicines, called biosimilars.
“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,” HHS Secretary Alex Azar said in a statement.
The FDA did not respond to a request for comment.
The Washington Post first reported on Tuesday that Mr. Gottlieb planned to resign.
“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!” Republican President Donald Trump wrote on Twitter on Tuesday.
In his resignation letter, Mr. Gottlieb touted several of the agency’s initiatives, including efforts to curb tobacco use, decrease the rate of opioid addiction, speed up approval of generic drugs and streamline the process for novel medical technologies such as gene therapy.
“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,” he wrote on Twitter, referring to Mr. Azar and President Trump by their Twitter handles.
Curbing E-Cigarette Use
Mr. Gottlieb’s signature policy initiative was his effort to reduce teen e-cigarette use. He expressed concern over the rise in the number of youths using flavored e-cigarettes after preliminary federal data showed teenage use had surged by more than 75% since last year, which the FDA described as an epidemic.
Under Mr. 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.