Washington Roundup: August 16, 2024

The Wall Street Journal reports,

• “The Food and Drug Administration turned down an ecstasy-based drug.

• “The agency rejected use of the drug, known as MDMA, along with mental-health therapy in the treatment of post-traumatic stress disorder.  It asked Lykos Therapeutics, which had sought the approval, to test the drug therapy further, the company said Friday.

• “The decision is a setback for decades of efforts to legalize psychedelics and a disappointment for veterans advocates and other groups that have been seeking a new, better medicine for treating the 13 million Americans with post-traumatic stress.

• “Yet it isn’t a surprise, after FDA staff and expert advisers raised questions about the studies evaluating whether the MDMA drug from Lykos Therapeutics worked safely.

• “Lykos said the FDA told the company it couldn’t approve the drug therapy based on the data submitted to date. The company said it would ask the FDA to reconsider its decision, as well as to discuss the agency’s recommendations for submitting another application.”

The Washington Post adds,

• “The Food and Drug Administration on Friday approved a nasal spray for serious allergic reactions to food, medications and insect stings, marking the first needle-free treatment for such conditions.

• “The epinephrine nasal spray is administered as a single dose in one nostril and will serve as a critical alternative to treating emergency allergic reactions without an injection, the agency said.

• “The two-milligram spray, called Neffy, is designed to block allergic reactions, including a serious condition called anaphylaxis, which can happen within seconds or minutes of being exposed to an allergen.

• “The decision introduces an alternative to auto-injector devices such as the EpiPen for blocking severe allergic reactions. It also vindicates the approach of Neffy manufacturer ARS Pharmaceuticals, which pitched its product as a superior way of treating anaphylaxis that overcomes people’s hesitation to inject themselves or someone else. Anaphylaxis can cause constriction of the airway.”

Govexec reports,

• “A new initiative from the Biden administration aims to quell a varied series of consumer “headaches” by reducing their extraneous time and processes, including for federal employees trying to file health insurance claims.

• “Detailed in a memo Monday [August 12], the “Time Is Money” initiative would touch upon processes across multiple industries that the White House deemed deliberate, time-consuming and burdensome for consumers, such as procuring refunds, canceling subscriptions and filing insurance claims.”  * * *

Here’s a link to an HHS and Labor Secretary message to health insurer CEOs about the new initiative.

The Wall Street Journal examines the state of the hospital at home business. “Institutions say it is safe and opens hospital beds, but policymakers fear it’s too pricey and lacks strict standards.”

Risk & Insurance alerts us that “Employers are expanding comprehensive wellbeing programs to meet employee needs, while adopting varied cost management strategies amid rising health and drug costs, a Gallagher benchmarking report finds. * * * View the complete benchmark report, including breakouts by region and employer size, on Gallagher’s website.”