Morning Briefing
Summaries of health policy coverage from major news organizations
Use Of Over-The-Counter Opill Is High Among First-Time Birth Control Users
CNN: Over-The-Counter Birth Control Pills Have Been Available In The US For Over A Year. Here’s Who’s Using Them
About two years after the US Food and Drug Administration approved the first over-the-counter birth control pill in the United States, a new study suggests that many people who may not have had access to contraception before are now using the over-the-counter option. More than a quarter – 26.2% – of people now using over-the-counter oral contraceptives were using no modern method of birth control before, according to the study published Monday in the medical journal JAMA Network Open. (Howard, 8/18)
On Barth syndrome —
Stat: Stealth BioTherapeutics Discloses FDA Rejection Letter In Effort To Rally Support
In a highly unusual move, a small biotech company has disclosed a rejection letter from the Food and Drug Administration in hopes of rallying support for regulatory approval of an ultra-rare disease drug. (Silverman, 8/18)
NBC News: For Kids With Barth Syndrome, Time Is Running Out, Parents Say, Unless The FDA Acts
Gilbert Dryden probably only has enough medication to get him through the end of October, his mother, Madison, figures. Seven-month-old Gilbert has a rare genetic condition called Barth syndrome, one that can have dire consequences, like heart failure, extreme muscle weakness and a dramatically reduced life expectancy. Children who die early often don’t see their fifth birthday. Two infant deaths were reported within the past week, according to the Barth Syndrome Foundation. (Brock and Edwards, 8/18)
More pharmaceutical news —
The New York Times: A Common Weight Loss Drug Can Treat Severe Liver Disease, F.D.A. Says
The Food and Drug Administration approved the weight loss drug Wegovy to treat an increasingly prevalent liver disease on Friday. Roughly 15 million people — six percent of adults in the United States — have metabolic dysfunction-associated steatohepatitis, known as MASH. Rates of the disease are rising. (Blum, 8/18)
Chicago Tribune: Abbott Scores A Win In Court As It Faces Baby Formula Suits
A federal judge has thrown out a second case against Abbott Laboratories over the safety of its formula for babies born prematurely — a decision with potential implications for hundreds of other similar cases. In the case, Maryland woman Keosha Diggs alleged that her son developed a life-threatening intestinal disease called necrotizing enterocolitis (NEC) after being fed specialized cow’s milk formula made by Abbott. Her son, who was born at 32 weeks gestation, then had to undergo surgery to remove a section of his intestine. (Schencker, 8/18)
AP: FDA Shifts From Expert Advisers To Ad Hoc Panels Under Marty Makary
When the Food and Drug Administration needs outside guidance, it normally turns to a trusted source: a large roster of expert advisers who are carefully vetted for their independence, credentials and judgment. But increasingly, the agency isn’t calling them. Instead, FDA Commissioner Marty Makary has launched a series of ad hoc “expert panels” to discuss antidepressants, menopause drugs and other topics with physicians and researchers who often have contrarian views and financial interests in the subjects. (Perrone, 8/18)
CIDRAP: Study Suggests Probiotics May Suppress Antibiotic Resistance Genes In Preterm Infants
A small UK study published last week in Nature Communications found that among a cohort of very low birth weight (VLBW) infants, those who received probiotic supplements had fewer antibiotic-resistance genes (ARGs) and multidrug-resistant (MDR) pathogens in their gut than those who didn't, even when they also received antibiotics. (Dall, 8/18)
