Morning Briefing
Summaries of health policy coverage from major news organizations
Anti-Tobacco Critics: FDA's Menthol Vape Approval 'Blow To Public Health'
Four menthol vaping products were authorized by the US Food and Drug Administration on Friday, the first non-tobacco-flavored e-cigarette products to get the agency鈥檚 sign-off. The decision drew harsh criticism from pediatricians and anti-tobacco groups, which called it 鈥渁 blow to public health鈥 and warned of potential for 鈥渄isastrous consequences鈥 to children. (Christensen, 6/21)
In 2022, Earl Fowlkes, a Black gay activist, denounced tobacco companies for marketing e-cigarettes to his community as the latest way to hook people on nicotine. A year later he declared that vaping saves Black and LGBTQ+ lives. Fowlkes鈥檚 promotion of looser e-cigarette regulations, which came as he developed a relationship with an industry trade group, illustrates how the tobacco industry has expanded alliances with activists representing Black, LGBTQ+ and other disenfranchised groups to defend products public health experts say are harmful. (Nirappil, 6/21)
In other news about the FDA 鈥
The U.S. Food and Drug Administration has approved Bristol Myers Squibb's combination therapy for treating colorectal cancer in patients with a specific gene mutation, the health regulator said on Friday. The approval under the agency's accelerated process was based on an early- to mid-stage study, in which 94 previously treated patients were administered the oral drug Krazati, in combination with cetuximab. (Santhosh and L, 6/21)
Researchers have discovered how a cell surface protein called Aplp1 can play a role in spreading material responsible for Parkinson's disease from cell-to-cell in the brain. Promisingly, an FDA-approved cancer drug that targets another protein called Lag3 鈥 which interacts with Aplp1 鈥 blocks the spread in mice, suggesting a potential therapy may already exist. (Dyer, 6/24)
On medical devices 鈥
When a new medical device hits the market, there鈥檚 typically still some uncertainty about whether it works. Device makers generally do not have to submit as much, or as rigorous, clinical data to the Food and Drug Administration as their biotech counterparts. Once FDA regulators decide a device is safe and effective, companies and researchers then attempt to track how the device performs in the real world. (Lawrence, 6/24)
A patient may be able to pursue a claim against a drug or medical device maker for failing to warn of a product's risks even if the warning would not have stopped the patient's doctor from recommending it, California's highest court has ruled. The California Supreme Court, in a unanimous opinion on Thursday by Justice Joshua Groban, revived a lawsuit against Somatics, the maker of an electroshock therapy device, by a woman who said she suffered brain damage after it was used to treat her severe depression. (Pierson, 6/21)