Top of the morning to you. And a fine one it is. Lots of sunshine and clear blue skies are once again enveloping the Pharmalot campus, where the official mascots are bounding about the grounds in search of creatures to annoy. As for us, we are as busy as ever hunting and gathering items of interest. We trust you have your own hectic agendas. So join us as we hoist the ever-present cup of stimulation — our choice today is coconut rum — and attack the fast-growing to-do list. Have a grand day, everyone, and do stay in touch. …
A trade group representing large compounding pharmacies has sued the U.S. Food and Drug Administration for a “reckless and arbitrary” decision to remove a widely prescribed Eli Lilly drug for combating diabetes and obesity from an official shortages list, STAT tells us. The Outsourcing Facilities Association argued that a shortage of the drug, known as tirzepatide, still exists and the agency action was a coup for the company that came at the expense of the public. Moreover, the trade group maintained the FDA move was “unlawful,” because it failed to follow so-called rule-making procedures and provide proper notice of its plans. The lawsuits follow an FDA announcement last week that Lilly determined its manufacturing capacity can meet “present and projected” national demand after a sustained shortage of the drug. The trade group, however, insisted the FDA “acted to benefit special interests, raise drug prices and deprive much of the public of access to a needed medicine.”
A U.S. appeals court ruled 2-1 that Merck is immune from an antitrust lawsuit accusing it of misleading regulators about the effectiveness of its mumps vaccine in order to ward off competition, Reuters says. The court found Merck is protected by a legal doctrine known as Noerr-Pennington immunity, which states that parties cannot face antitrust claims for petitioning the government even if they are advocating for government action that would reduce competition. A group of doctors and medical practices claimed they overpaid for the vaccine, which was the only mumps shot in the U.S. from 1967 until 2022. It is sold as part of a combined vaccine against mumps, measles, and rubella, known as MMR-II, and another product called ProQuad that additionally protects against varicella, also known as chickenpox. In the late 1990s, the FDA raised concerns the vaccine lost potency toward the end of its 24-month shelf life. Merck responded by boosting the initial potency in hopes of addressing the problem.
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