Good morning, everyone, and welcome to another working week. We hope the weekend respite was enjoyable and invigorating, because that oh-so predictable routine of phone calls, online meetings, and scurrying about has, of course, returned. But you knew this would happen, yes? To cope, we are firing up the trusty coffee kettle to brew another cup of stimulation. Our choice today is the scrumptious Junior’s Cheesecake, which we are proud to say originated in our homeland. Please feel free to join us. Meanwhile, here are a few tidbits to help you get started. We hope you have a smashing day and conquer the world. And do keep in touch. …
Martin Makary, President-elect Trump’s pick to run the U.S. Food and Drug Administration, is an executive of the telehealth company Sesame, which connects consumers to physicians who can prescribe compounded weight-loss drugs. If confirmed as FDA commissioner, Makary would take the lead of the agency as it grapples with high-stakes policy issues that could impact Sesame’s business, STAT explains. The FDA — and patients — have been caught in the middle of a fight between the makers of branded drugs used to treat obesity and pharmacies that have been compounding cheaper versions of those drugs for more than two years. Pharmacies are allowed to compound drugs while they are in short supply, and the FDA determines whether they are in shortage. That task had not been a problem until the agency was faced with whether to take a weight loss drug off of the shortage list. Sesame offers semaglutide, which is still on the shortage list. If the FDA were to remove semaglutide from the shortage list, it would directly affect Sesame, and the agency could face that decision during the next administration.
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The battle over prescription drug discounts offered to hospitals under a federal program escalated as Sanofi became the third pharmaceutical company to disclose plans to change the way it will make payments, STAT says. In a letter sent to hospitals and clinics on Friday, Sanofi indicated that certain hospitals covered by the 340B Drug Discount Program would receive credits for medicines ordered at full price from a wholesaler. However, the credit would only be issued after the hospital or clinic submits claims data, including the prescription order, a patient’s hospital visit, and dispensing information. As of January, Sanofi plans to verify that the patient receiving a drug fits within the definition of eligibility according to the U.S. Health Resources and Services Administration, the agency that oversees the program, according to the letter. The idea is for hospitals to receive a credit before they pay a wholesaler for a medicine.
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