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The Food and Drug Administration (FDA) has reaffirmed that Mounjaro and Zepbound are no longer missing after a reevaluation of its decision to remove it from the federal drug shortage list amid intense pushback from compounded drug makers.
The FDA determined in October that the active ingredient in Mounjaro and Zepbound, tirzepatide, was no longer missing after nearly two years.
With Eli Lilly’s drug off the shortage list, compounding pharmacies were technically no longer allowed to sell copycat versions of the drug. Those pharmacies and telehealth companies that have been able to sell the highly lucrative drug protested the FDA’s decision, submit a claim arguing that the shortage persisted.
In response, the FDA said less than two weeks after removing tirzepatide from the shortage list that it would reconsider the action. The agency said Thursday, two months later, that it had reached the same conclusion once again.
“FDA determines that the shortage of tirzepatide injection products has been resolved,” the agency said in a letter to Patty Donnelly, Eli Lilly’s senior vice president of global quality.
“FDA has also considered potentially relevant information regarding the determination of shortages from patients, health care providers, and others, including compounds, along with data from other sources that we independently identified,” the letter continued .
“After carefully evaluating this information, we find that it has significant limitations,” he says. “We conclude that this information does not undermine or outweigh the evidence showing that Lilly’s offering is meeting or exceeding demand and will, in our best judgment, meet or exceed anticipated demand.”
Semaglutide, the active ingredient in Ozempic and Wegovy, was found “available” by the FDA also in October, but the agency has not yet removed it from the shortage list.
The FDA also reiterated its position on compounding pharmacies, setting deadlines for when compounders must stop sales of compounded tirzepatide. Pharmacies that fill individual patient prescriptions, known as 503A compounding pharmacies, have 60 days or until February 18th.
Pharmacies labeled 503B, or those that can manufacture bulk orders and are the most used by telehealth companies, have 90 days or until March 19. The difference in timelines was explained because 503Bs offer “more quality assurances.” that 503A and these facilities investing “relatively more resources and time before we can produce the product.”
In a statement to The Hill, a Lilly spokesperson said: “Today’s decision by the FDA, which reiterated that the shortage of tirzepatide has been resolved, reflects the tireless work of our manufacturing and quality colleagues to safely expand our manufacturing capacity to bring these medicines to the people who need them.”
The company’s spokesman said manufacturers “must stop” selling their unbranded versions of tirezapatide and praised the FDA’s decision as a “critical step to protect patients from the dangers of counterfeits and compounded imitations.”
The Hill has reached out to the Association of Outsourcing Facilities, the organization that sued the FDA to remove tirzepatide from the shortage list, for comment.
— Updated at 10:50 am
