FDA keeps Mounjaro off shortage list after reevaluation

The Food and Drug Administration (FDA) has reaffirmed that Mounjaro and Zepbound are no longer in shortage following a reevaluation of its decision to remove it from federal drug shortage list amid intense pushback from compounded drug manufacturers.

The FDA determined in October that the active ingredient in Mounjaro and Zepbound — tirzepatide — was no longer in shortage after nearly two years.

With the drug from Eli Lilly off the shortage list, compounding pharmacies were technically no longer permitted to sell copycat versions of the drug. Those pharmacies and telehealth companies that have been able to sell the highly lucrative medicine protested the FDA's decision, filing a lawsuit arguing that the shortage persisted.

In response, the FDA said less than two weeks after it took tirzepatide off the shortage list that it would reconsider the action. The agency said Thursday, two months later, that it had come to the same conclusion once again.

"FDA determines that the tirzepatide injection product shortage is resolved," the agency said in a letter to Patty Donnelly, Eli Lilly senior vice president of global quality.

"FDA has also considered potentially relevant information regarding the shortage determination from patients, healthcare providers, and others, including compounders, along with data from other sources that we independently identified," the letter continued.

"After carefully evaluating this information, we find that it has important limitations," it reads. "We conclude that this information does not undermine or outweigh the evidence demonstrating that Lilly’s supply is currently meeting or exceeding demand and that, based on our best judgment, it will meet or exceed projected demand."

Semaglutide, the active ingredient in Ozempic and Wegovy, was found to be "available" by the FDA in October as well but the agency has not yet taken it off the shortage list.

The FDA also reiterated its stance on compounding pharmacies, setting deadlines for when compounders must halt sales of compounded tirzepatide. Pharmacies that fulfill prescriptions for individual patients, known as 503A compounding pharmacies, have 60 days or until Feb. 18.

Pharmacies labeled as 503B, or those that are able to manufacturer bulk orders and are the ones most utilized by telehealth companies, have 90 days or until March 19. The difference in timelines was explained as being due to 503Bs providing "more assurances of quality" than 503As and these facilities investing "relatively more resources and time before they can produce product."

In a statement to The Hill, a Lilly spokesperson said, "FDA’s decision today, reiterating that the tirzepatide shortage is resolved, reflects the tireless work of our manufacturing and quality colleagues to safely expand our manufacturing capacity to bring these medicines to people who need them."

The company spokesperson said compounders "must stop" selling their unbranded versions of tirzepatide and praised the FDA's decision as a "critical step towards protecting patients from the dangers of counterfeit and compounded knockoffs."

The Hill has reached out to the Outsourcing Facilities Association, the organization that sued the FDA over taking tirzepatide off the shortage list, for comment.

— Updated at 10:50 a.m.