Morning Briefing
Summaries of health policy coverage from major news organizations
Study: Taking Acetaminophen In Pregnancy Not Linked To Autism Risk
NBC News: Acetaminophen During Pregnancy Not Associated With ADHD Or Autism Risk
Taking acetaminophen during pregnancy has been associated with an increased risk of autism, and ADHD in children in some research. A new study suggests that it is not acetaminophen that is linked to neurodevelopmental disorders, but likely other issues such as genetics. The new report, published in JAMA on Tuesday, focused on data from more than 2 million Swedish children who were followed for up to 26 years. (Carroll, 4/9)
In other pharmaceutical and technology news —
AP: Maker Of Defective Sleep Apnea Devices Ordered To Overhaul Manufacturing
The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements, under a long-awaited settlement announced Tuesday by federal officials. Philips will be required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes, according to a court order announced by the U.S. Department of Justice. The company must also continue to replace, repair or provide refunds to all U.S. customers who got the defective devices, the department said. (Perrone, 4/9)
Stat: Drug Company Defends 486% Price Increase For Eye Treatment
In an era when huge price hikes for prescription drugs are almost guaranteed to draw criticism, is there any circumstance when a 486% percent increase for a medicine might appear to be justified? A small company called Harrow argues that it can make the case for an injectable eye treatment that has been used to combat several serious conditions. Company executives maintain the medication, which has been largely out of stock for the past few years, requires substantial investment in order to restore a steady supply and, moreover, was substantially underpriced. (Silverman, 4/10)
Reuters: US FDA Declines To Approve Supernus' Parkinson's Combination Again
Supernus Pharmaceuticals said on Monday the U.S. FDA declined to approve its drug-device combination to treat movement-related symptoms of Parkinson's disease. This is the second time the regulator has refused to approve, dealing a blow to the company's years-long effort to market its pump-based treatment. (4/8)
The Boston Globe: Seaport Therapeutics Launches With $100 Million To Develop New Ways To Treat Mental Disorders
The team behind Karuna Therapeutics, the Boston biotech that was bought by drug giant Bristol Myers Squibb in a $14 billion deal in December, launched another company on Tuesday called Seaport Therapeutics that will again focus on neuropsychiatric medicines. The new Boston company has landed $100 million in its first round of fund-raising and will be led by Daphne Zohar, the founding chief executive of biotech startup creator PureTech Health, which helped launch Karuna and Seaport. (Saltzman, 4/9)
CIDRAP: US Drugs With Noted Supply-Chain Risks 5 Times More Likely To Go Into Shortage In Early COVID
In the first few months of the COVID-19 pandemic, US prescription drugs flagged for potential supply-chain disruptions were nearly five times more likely to go into shortage than those without such warnings, finds a University of Pittsburgh–led study. Shortages were defined as at least a 33% drop in drug units sold within 6 months of a supply chain–disruption report to the US Food and Drug Administration (FDA) or the American Society of Health-System Pharmacists (ASHP). Examples of such reports include those involving quality problems (eg, microbial contamination), unforeseen circumstances (eg, natural disasters), and discontinuation. (Van Beusekom, 4/5)
Newsweek: Could A Vaccine Solve The Opioid Crisis?
Congressman David Schweikert introduced a bill that would provide a prize for the successful development of a vaccine "to prevent, treat, or mitigate opioid, cocaine, methamphetamine, or alcohol use disorder." (Phillips, 4/10)
