“A trade organization representing compounding pharmacies that make unbranded versions of the weight loss drugs Mounjaro and Zepbound has filed a lawsuit against the Food and Drug Administration for declaring an end to the shortage, effectively halting the sale of ‘copycat’ versions of these drugs,” Joseph Choi writes over at The Hill. “On Oct. 2, the F.D.A. announced that the nearly two-year-long shortage of tirzepatide, the active ingredient in Mounjaro and Zepbound, had ended. This was after the agency said it had confirmed the manufacturer, Eli Lilly, had a manufacturing capacity that ‘can meet the present and projected national demand.’ With the shortage over, the ability of compounding pharmacies to sell unbranded, replicated versions of these drugs came to a near halt. There are two types of compounding pharmacies: 503A and 503B. The Outsourcing Facilities Association represents 503B compounding pharmacies, which can create prescription-specific compounded drugs as well as bulk orders. The O.F.A. and the compounding pharmacy North American Custom Laboratories filed their lawsuit against the F.D.A. on Monday, alleging the agency was abruptly depriving patients of much needed treatment and artificially raising drug prices. Ignoring evidence that the shortage persists, F.D.A. removed Tirzepatide from the shortage list without notice, without soliciting input from affected parties and the public, and without meaningful rationale,’ said their complaint.” Joseph Choi, “Trade group sues FDA over ending Mounjaro/Zepbound shortage,” The Hill.
