The U.S. Food and Drug Administration (FDA) recently sparked controversy by removing tirzepatide, a drug used for treating diabetes and promoting significant weight loss, from its official drug shortage list. This move has led to a legal battle from pharmacy compounders who argue that the drug is still in short supply and that patients cannot access it easily.
Tirzepatide, marketed under the brand names Mounjaro and Zepbound by Eli Lilly, along with semaglutide (Ozempic, Wegovy) from Novo Nordisk, have become popular not only for managing diabetes but also for their weight loss effects. When these drugs were placed on the shortage list, compounding pharmacies began producing their own versions, which were allowed in the market as long as the drugs remained unavailable commercially.
However, the FDA’s decision to remove tirzepatide from the shortage list has caused a stir. The Outsourcing Facilities Association, which represents pharmacies and compounding companies, quickly filed a lawsuit against the FDA. The association claimed that the drug was still in limited supply and that many patients were struggling to get prescriptions filled. They described the FDA’s decision as “reckless and arbitrary,” and sought a temporary restraining order from a Texas federal court to halt the FDA’s action.
In response, the FDA reconsidered its decision, stating it would review its move and pause its removal of tirzepatide from the shortage list. The agency filed a motion to pause the lawsuit and revisit the case, a request that was granted by U.S. District Judge Mark Pittman. The judge’s decision puts the lawsuit on hold while the FDA reassesses whether there is still a shortage of the drug.
This legal delay allows compounding pharmacies and outsourcers to continue making and selling their own versions of tirzepatide, ensuring that patients who are still facing prescription delays can access the drug. Furthermore, the FDA announced that it would not take any enforcement action against these pharmacies during its reconsideration process.
The legal and regulatory tension arises because once a drug is removed from the shortage list, pharmacies can no longer legally produce their own versions unless certain exceptions apply. For compounding pharmacies, this is a significant issue as they depend on the shortage status to legally produce alternatives.
Eli Lilly, the manufacturer of tirzepatide, maintains that the drug is readily available and cautions against using compounded versions. A company representative stressed that “all doses of Lilly’s FDA-approved medicines are available” and warned that untested compounded versions of the drug could pose health risks.
The FDA’s enforcement discretion will remain in effect for two weeks after it reconsiders its decision. However, if the agency again removes tirzepatide from the shortage list and the drug remains unavailable, it will likely face more legal challenges.
This issue could also gain further attention in light of the upcoming U.S. presidential election, with critics arguing that the FDA, under potential leadership changes, should be careful in its decision-making to avoid public backlash.
