FDA Eyes Smartphone Apps Linked To Prescription Drugs In Part Of Flurry Of New Digital Health Guidelines
FDA Commissioner Scott Gottlieb has proposed treating some of the apps like "promotional material," which would allow companies to make minor updates without having to go back to the agency for approval.
Stat:
FDA Proposes New Regulations For Some Health Smartphone Apps
The Food and Drug Administration wants to ramp up the way it regulates smartphone apps linked to prescription drugs — like medication reminders or symptom trackers. In a new proposal released Monday, the agency said it may treat some apps like drug advertisements — which would allow companies to distribute apps without going through a review process with every update. Right now, the apps aren’t covered by existing regulations. (Sullivan, 11/19)
In other news from the FDA —
The Wall Street Journal:
FDA Menthol Ban Will Be A Slow Burn
The Food and Drug Administration’s war on menthol cigarettes could take years. Investors have time to sift the ashes and decide which tobacco stocks are best prepared for tougher U.S. regulations and a shift to alternative forms of smoking. FDA Commissioner Scott Gottlieb last week said he wants to ban menthol brands, which are more addictive than regular tobacco, but didn’t give a timeline. He will immediately restrict sales of flavored e-cigarettes to fight rocketing use among young Americans—3.6 million middle- and high-school students are now e-smokers, up from 2.1 million in 2017. (Ryan, 11/20)
