Lawsuit Triggered As FDA Declares End Of Mounjaro, Zepbound Shortage
Compounding pharmacies sued the FDA after its declaration, bringing an end to the sale of the "copycat" drugs they provide. Meanwhile, as demand soars for weight loss drugs, WeightWatchers eyes compound version of the drug for participants in its programs.
The Hill:
Pharmacies Sue FDA Over Ending Mounjaro, Zepbound Shortage
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 (FDA) for declaring an end to the shortage, effectively halting the sale of “copycat” versions of these drugs. On Oct. 2, the FDA announced that the nearly two-year-long shortage of tirzepatide, the active ingredient in Mounjaro and Zepbound, had ended. (Choi, 10/8)
Reuters:
WeightWatchers To Offer Compounded Version Of Novo Nordisk's Weight-Loss Drug
WeightWatchers said on Tuesday it would offer a compounded version of Novo Nordisk's popular obesity drug Wegovy as part of its weight-management programs, sending its shares nearly 47% higher to an over two-month closing high. Soaring demand for weight-loss drugs such as Wegovy and Eli Lilly's Zepbound, shown to help patients lose as much as 20% of weight on average, has led to shortages that allowed drug compounders to produce them under U.S. regulations. (10/8)
Stat:
ViiV Takes Steps To Widen Access To HIV Prevention Drug
Responding to growing pressure, ViiV Healthcare announced steps to widen access to its HIV prevention medicine in low- and middle-income countries, marking the second time in two years the company is taking such steps. But as before, the move was met with criticism over certain details. The latest effort involves tripling the annual supply of the drug, a long-acting medication known as cabotegravir, in hopes of making more than 2 million doses available during 2025 and 2026. The company — which is largely owned by GSK, while Pfizer and Shionogi hold minority stakes — explained this will roughly triple the availability this year in those countries. (Silverman, 10/8)
Meanwhile, in drug pricing news —
Stat:
PBMs Seek To Remove FTC Chair Lina Khan From Insulin-Price Suit
UnitedHealth Group and CVS Health have petitioned a federal judge to sideline Federal Trade Commission Chair Lina Khan and the two Democratic FTC commissioners from the agency’s lawsuit against the country’s largest pharmacy benefit managers. Attorneys for UnitedHealth’s Optum Rx and CVS Caremark contend Khan, Rebecca Kelly Slaughter, and Alvaro Bedoya “have made repeated incorrect prejudgments” about the PBMs as well as their group purchasing organizations that aggregate rebates from drug manufacturers, according to legal filings dated Tuesday night. (Herman, 10/9)
