FDA Rules Aim To Rein In Distracting TV Drug Ads
The agency's new guidelines require drugmakers to provide viewers with a clearer picture of medications' risks and side effects. Congress also is looking at giving the FDA authority to regulate drug promotions on social media platforms. Also in the news: Botox; CAR-T therapy; and more.
AP:
New FDA Rules For TV Drug Ads: Simpler Language And No Distractions
Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: New rules require drugmakers to be clearer and more direct when explaining their medications’ risks and side effects. The U.S. Food and Drug Administration spent more than 15 years crafting the guidelines, which are designed to do away with industry practices that downplay or distract viewers from risk information. Many companies have already adopted the rules, which become binding Nov. 20. But while regulators were drafting them, a new trend emerged: thousands of pharma influencers pushing drugs online with little oversight. A new bill in Congress would compel the FDA to more aggressively police such promotions on social media platforms. (Perrone, 11/14)
Stat:
FDA Scolds Merz Over 'Misleading' Post On Its Botox Rival
The Food and Drug Administration has scolded Merz Pharmaceutical for making misleading claims on Instagram about the safety and effectiveness of an injectable treatment for smoothing facial lines, the fifth time this year the agency has taken a pharmaceutical company to task for its marketing. (Silverman, 11/14)
Stat:
CAR-T Therapy Shows Promise For 'Worst Imaginable' Brain Tumor
Michelle Monje-Deisseroth says she first treated patients with “the worst imaginable childhood brain tumor” as a medical student about 20 years ago. Diffuse intrinsic pontine gliomas, or DIPG, shackle themselves so insidiously around a young person’s brainstem that no chemo or scalpel can wrest them out. Most children didn’t survive a year. (Mast, 11/15)
Stat:
European Regulators Now Recommend Alzheimer’s Treatment Leqembi
Reversing an earlier decision, European regulators on Thursday recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved, saying that the benefits of the treatment outweigh the risks in a select group of patients. (Joseph, 11/14)
Also —
The Washington Post:
A Scientist Experimented On Herself To Treat Her Cancer. It Worked.
When Beata Halassy learned in summer 2020 that her breast cancer had come back, she made a bold decision. As a virologist at the University of Zagreb in Croatia, she knew that researchers around the world were testing virus-based cancer treatments that could avoid the destructive side effects of conventional treatments like chemotherapy. Halassy, who studies viruses for a living, decided to test some of them on herself. (Wu, 11/14)
