Morning Briefing
Summaries of health policy coverage from major news organizations
Federal Appeals Court Overrules Dismissal Of Tylenol-Autism Lawsuits
The New York Times: Appeals Court Revives Lawsuits Tying Tylenol Use In Pregnancy To Autism And A.D.H.D.
A U.S. appeals court on Monday reversed a trial judge’s decision to dismiss lawsuits against the makers of Tylenol, reviving hundreds of cases filed by families who claim that their children developed autism or attention deficit hyperactivity disorder after their mothers took Tylenol during pregnancy. The judges, all Democratic appointees, ruled that the lower court overstepped by excluding scientific evidence presented by expert witnesses on behalf of the plaintiffs. That expert testimony, the judges argued, was valid evidence about a scientific question that they said was still under dispute. (Ghorayshi, 7/13)
News from the FDA —
FiercePharma: FDA Proposes To Simplify Registration Of US Drug Manufacturing
In an initiative to increase the efficiency of drug manufacturing in the United States, the FDA has proposed a streamlined pathway for registering production facilities that operate under a “hub-and-spoke” model. The new rule would cut red tape, allowing manufacturing entities that have equivalent production units at different locations to register as a single establishment instead of having each unit register and gain clearance separately. (Dunleavy, 7/13)
The Examination: FDA Authorized Zyn Nicotine Pouches Without Knowing What They Were Made Of, Says Former Agency Scientist
A toxicologist says the agency failed to consider whether the pouch material could shed microplastics. (Chapman and Kranhold, 7/14)
More pharma and tech developments —
HealthDay: Adderall Misuse Falls Sharply Among Young Adults, Study Finds
Half as many young adults are misusing Adderall, Ritalin and other ADHD medications these days to help them remain alert at study or work, a new evidence review says. Misuse of ADHD stimulant meds among adults under 30 fell from 7.5% in 2016 to 3.7% in 2023, researchers report in the Journal of Clinical Psychopharmacology. (Thompson, 7/13)
Stat: AIDS Activists Slam Biden R&D Deal With Gilead Over HIV Prevention Drug Patents
After more than a year of squabbling, a group of AIDS activists obtained an R&D agreement that was at the heart of a settlement between the U.S. government and Gilead Sciences over patents for HIV prevention drugs. But in their view, the deal shows the Biden administration missed a “historic” opportunity to invest in — and expand access to — HIV prevention tools. (Silverman, 7/13)
The New York Times: Agitation In Dementia Can Be Helped By Medical Cannabis, Study Suggests
A combination of THC and CBD eased symptoms in an especially frail population: patients with advanced dementia near the end of their lives. (Belluck, 7/14)
MedPage Today: Study Dampens Hope For GLP-1s As Insulin Off-Ramp In Type 2 Diabetes
Adding a GLP-1 receptor agonist was not associated with a lower likelihood of discontinuing existing basal insulin therapy among veterans with type 2 diabetes compared with other glucose-lowering agents, a target emulation trial found. (Monaco, 7/13)
Kansas City Star: How A Vibration Plate Affects Digestion, Skin Itching And Lymphatic Flow
Vibration plate popularity keeps growing, and so does the list of questions about what these buzzing platforms actually do for the body. Here are direct answers to the biggest ones, drawn from researchers, doctors and fitness experts. (Agate, 7/13)
KFF Health News: Knee Pain? Ragged Cartilage? Research Suggests Surgery’s Not The Best Answer
Thousands of Americans who undergo a common knee surgery might be making their problems worse rather than better. Researchers who followed patients for 10 years after they received either the actual procedure, arthroscopic knee surgery to trim degenerative cartilage tears, or merely “sham surgery” — a skin incision — for knee pain, found that the surgery provided little or no benefit and was, in fact, associated with accelerated osteoarthritis and higher rates of reoperation. That generally meant a total knee replacement. (Rosenthal, 7/14)
