Pharmacists may continue making compounded versions of the weight-loss medication tirzepatide while the U.S. Food and Drug Administration revisits its Oct. 2 decision to remove the medicine from a national drug shortage list.
What prompted the FDA to reconsider its decision? On Oct. 7, a compounding trade group filed a lawsuit challenging the agency's action, saying there was still a shortage of the wildly popular drug. On Friday, the FDA responded in a court filing that compounding pharmacies could continue making the drug while the agency re-evaluates its finding, NBC News reported.
Shortages of tirzepatide, sold as a diabetes drug (Mounjaro) and a weight-loss medication (Zepbound), have fueled demand for compounding pharmacies to make their own versions of the medicine, which patients say are cheaper and easier to get.
During FDA-declared drug shortages, compounding pharmacies can make versions that are copies of the brand-name drugs in shortage.
But the agency’s Oct. 2 announcement said pharmacies that produce large batches of medications would no longer be able to accept new orders of tirzepatide and had 60 days to fill their existing orders.
The agency's Friday filing said its latest move was “effectively the relief that Plaintiffs sought in their motion.” In the filing, the agency said it wouldn’t “take action” against the plaintiffs and their members making compounded versions of the drugs as it re-evaluates its decision, NBC News reported.
To meet demand, drug maker Lilly has taken steps to ramp up production of tirzepatide, committing billions to a new manufacturing plant dedicated to producing more of the drug, the company announced in May.
Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said the group is still hearing reports from patients and caregivers suggesting tirzepatide continues to be hard to find.
“This can be the kind of thing that just takes a couple of weeks for supply to even out,” he told NBC News. “Distribution centers get replenished and then they send it out to pharmacies. The pharmacies probably all have back orders and they have customers that maybe have been getting it from the compounding pharmacy and are now trying to get it from a retail pharmacy and community pharmacy.”
Meanwhile, Lilly says tirzepatide is no longer in shortage.
In a statement issued Monday, Lilly spokesman Jared Shapiro told NBC News that all doses of Mounjaro and Zepbound are available, warning that it’s important that patients “not be exposed to the risks in taking untested, unapproved knockoffs.”
“Nothing changes the fact that, as FDA has recognized, Mounjaro and Zepbound are available and the shortage remains ‘resolved,’” Shapiro added.
The FDA didn’t respond to a request for comment on its reversal.
Meanwhile, Lee Rosebush, chairman of the Outsourcing Facilities Association, which filed the lawsuit, said in a statement that it was “relieved, for our members and the many patients that they serve.”
“We believe that this is a fair resolution in light of the agency’s rash decision to take the drug off the list at a time when the agency has acknowledged ‘supply disruptions,’” Rosebush said. “Most important, should the FDA repeat its removal decision when a shortage still genuinely exists, we will return to court.”
More information
Drugs.com has more on weight-loss drugs.
SOURCE: U.S. District Court for the Northern District of Texas, court filing, Oct. 7, 2024; NBC News
