FDA Commissioner Scott Gottlieb revealed on Tuesday that he’s planning to resign, saying he wants to spend more time with his family. Although his tenure at the helm of FDA may be best-remembered for its crackdown on teen vaping and e-cigarette sales, his successor will have to focus on areas from drug prices to cannabis regulation.
Here are four pressing issues that will be waiting for the next FDA commissioner.
Tobacco and e-cigarette regulation
Gottlieb took a tough stand against teen smoking and vaping by sending letters to vape manufacturers and retailers about selling products to those who are underage, warning the companies that they need to prevent teen smoking or risk civil or criminal charges. He specifically targeted Juul for making and marketing products aimed at a younger demographic.
The FDA also included the dangers of vaping in the latest edition of its anti-teen-smoking The Real Cost campaign.
After Gottlieb’s resignation announcement, Cliff Douglas, VP of tobacco control at the American Cancer Society, expressed concern about who will continue the fight.
“It’s critical that his successor champions protecting kids and the rest of the nation against the tobacco epidemic,” said Douglas in an interview with The New York Times.
Increased approval of affordable medicines
Gottlieb also fought for the development of more affordable drugs. To bring down drug prices, he implemented the Drug Competition Action Plan and targeted drugmakers that used tactics to delay the development of generic treatments. He also advocated for quicker approval of generics and biosimilars so they would be accessible for patients in need.
Innovation in healthcare
Silicon Valley will feel the effects of Gottlieb’s resignation. He advocated for innovation in healthcare and the development of drugs, as well as a better regulatory-approval process in the FDA. Gottlieb’s FDA championed the development of the digital health program, Pre-Cert, which improved approval times for low-risk health products, speeding up adoption of technologies and affecting companies such as Apple and Samsung.
Gottlieb was also supportive of moves like Amazon’s acquisition of PillPack, stating that “disruptive competition is a good thing,” as it could curb drug prices and better promote generics.
Robin Goldstein, a former Apple health team executive, said Gottlieb was “willing to explore innovation originating from Silicon Valley in an effort to begin to reimagine the future of healthcare and medicine” in an interview with CNBC.
Cannabis and CBD regulation in medication, food, drinks, and even cosmetics
During Gottlieb’s time as commissioner, the FDA approved the first CBD-based treatment in June 2018. GW Pharmaceuticals’ Epidiolex treats two rare forms of epilepsy.
Last week, Gottlieb said meetings would be held in April to discuss how to regulate the cannabis-derived ingredient CBD, which was legalized in December via the 2018 Farm Bill. However, it cannot be used in food, drinks, and cosmetics without FDA approval.