According to Fraiser Kansteiner’s article published on January 2, 2025 in Fierce Pharma (here), “Lilly on Wednesday filed a motion to intervene in a lawsuit brought by compounding industry group the Outsourcing Facilities Association (OFA) and compounder FarmaKeio Custom Compounding in U.S. District Court in Fort Worth, Texas.”
As so the saga goes on. Lilly is trying to protect its franchise tirzepatide product from 503A compounding pharmacies and 503B outsourcing pharmacies as the debate continues about the FDA’s latest decision that the shortage of tirzepatide is over (see previous post here, which describes the FDA’s limited enforcement periods for both types of compounders). How long will this battle keep up? My guess is that we haven’t seen the last of the litigation or the last of the FDA’s pronouncements on its current decision. Will that decision be flipped again? Stay tuned as what plays out on the “final” GLP-1 shortage decision could have long-lasting implications for other compounded products. Another question’s answer that we may need to watch is whether the Supreme Court’s overturning of the Chevron decision could play into the drug shortage and/or the compounding debate over the FDA’s current decisions on GLP-1 compounded products as well as how it may impact the Agency’s future decision-making process.
