Gottlieb Resigns from FDA, Focused on Generics and e-Cigarettes

March 7, 2019
Valerie DeBenedette

Valerie DeBenedette is a medical news writer in Putnam County, N.Y.

Scott Gottlieb’s tenure at the FDA was marked by hundreds of generic approvals and aggressive moves against the tobacco industry and vaping.

The unexpected resignation of Scott Gottlieb, MD, as commissioner of the FDA startled the healthcare industry. He will be stepping down as commissioner of the FDA at the end of March.

During a time of political divisiveness, Gottlieb won bipartisan praise for his public health initiatives. His tenure has been marked by his aggressive work to reduce tobacco use by teens and a large increase in the approvals of generic drugs. He also took on issues like drug pricing. Unusual for the head of the FDA, he was active in nutritional matters, such as keeping Obama-era requirements that restaurant menus post calorie counts and that food labels include information on added sugar.

In the two years since Gottlieb took the job, the FDA approved a record number of generic drugs, new drugs, and medical devices. He spoke publicly about high costs of prescription drugs, a subject most FDA heads shy away from. In 2017, the FDA released the Drug Competition Action Plan, which is intended to lower barriers for creating and marketing generic drugs. Gottlieb spoke out against drug makers who use tactics intended to delay development of generic versions of medications, such as refusing to release drug samples needed to develop generics. The FDA even started a public list of complaints against companies that used these tactics.

The quickening pace of approvals for biosimilar drugs is directly attributable to Gottieb, says Christine Simmon, JD, executive director of the Biosimilars Counsil of the Association for Accessible Medicines. "He has really made biosimilars a focal point of the agency's efforts." she tells Drug Topics. "Just by talking about them in addition to approving them, I think has as put them front and center in the minds of policy makers looking for solutions to high drug prices."

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“APhA wishes Commissioner Gottlieb well in his next endeavor,” says CEO Thomas E. Menighan, BSPharm, MBA, FAPhA, in a statement to Drug Topics. Looking forward to whoever the next commissioner will be, Menighan adds: “APhA is committed to continuing its work with the FDA to address issues to secure the quality and safety of our nation’s medication distribution and use systems, access to affordable pharmaceuticals and technology, and optimization of pharmacists’ knowledge and skills to improve our nation’s public health.”

The American Cancer Society praised Gottlieb’s work against vaping and teenaged use of tobacco, according to the New York Times. “Gottlieb has taken historic steps to take on this epidemic in a new way, including such proposals as reducing nicotine in cigarettes to nonaddictive levels and now pursuing a potential ban on menthol in cigarettes, so it is critical that whoever succeeds him picks up that mantel and treats it with equal priority that he has given it,” says Cliff Douglas, vice president of tobacco control at the society.

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Gottlieb says that he is quitting because he was tired of splitting time between Washington and his family home in Connecticut, where he and his wife are raising their three children. He had previously worked at the FDA as deputy commissioner for Medical and Scientific Affairs. He had also been a venture capitalist, and served as a board member and consultant for pharmaceutical companies.