Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where we have clear blue skies and chilly — not frigid — breezes greeting us today. Who could ask for anything more? Actually, we could — it is time to reheat the coffee kettle for another cup of stimulation. Our choice today is strawberry creme, a pantry favorite. Please feel free to join us. And there appears to be new evidence this may be worth doing. Meanwhile, here are your tidbits. Hope you have a productive and meaningful day, and, as always, please do keep in touch. We have adjusted our settings to accept postcards and telegrams. This is the modern world, after all…
The U.S. Food and Drug Administration late last year issued a warning letter to MedisourceRx, a compounding pharmacy owned by Hims & Hers, six months after a facility was cited for troubling problems during an inspection, STAT reports. One violation involved a failure to report a serious adverse event experienced by a patient who had taken a compounded version of semaglutide, the chemical name for the Wegovy weight loss medication sold by Novo Nordisk, according to an FDA inspection report of the Los Alamitos, Calif., facility last May and June. The incident occurred in January 2025, when a patient reported “severe” stomach issues and spent three nights in a hospital after taking the compounded injectable drug. But MedisourceRx, which Hims & Hers had acquired in September 2024, did not report the problem to the FDA within 15 days after receiving the information as required by law. FDA inspectors also found an “infestation” of rodents, birds, insects, and other vermin in buildings used to manufacture, process, or hold medicines.
A U.S. appeals court rejected a bid by two drugmakers to block a Louisiana law that regulates how manufacturers can supply federally discounted drugs to pharmacies, Bloomberg Law notes. The U.S. Court of Appeals for the Fifth Circuit affirmed a lower court decision that found Louisiana’s Act 358, which prevents drug makers from denying or restricting the delivery of discounted drugs to pharmacies, was not preempted by the federal 340B Drug Discount program. AbbVie and AstraZeneca argued the state law improperly forces pharmaceutical companies to supply so-called contract pharmacies as part of the discount program. Five years ago, many drugmakers began limiting some discounts when hospitals or clinics bought medicines and then shipped them to contracted pharmacies for patients to pick up or for delivery, instead of using their own in-house pharmacies. The drug companies alleged that using contract pharmacies led to abuses, such as duplicate billings, product diversions, and ineligible rebates.Continue to STAT+ to read the full story…