Federal regulators shook up a rapidly growing pharmaceutical marketplace when they announced that tirzepatide, the active ingredient in Eli Lilly’s Mounjaro and Zepbound, was no longer in shortage after nearly two years.
When drugs are in shortage, licensed outsourcing facilities can create “compounded” versions of the drug to ensure patients have access.
Telehealth companies like Hims & Hers and Noom jumped into the market seeking to fill the void, contracting with a Food and Drug Administration-regulated compounding pharmacy to make their own versions.
But with the shortage over, the ability of compounding pharmacies to make and sell unbranded, replicated versions of these drugs came to a near halt.
Pharmacies that sold unbranded copies of those drugs are now mounting an industry-wide effort to reverse that decision. In the week since the shortage was declared over, compounding pharmacies have launched an intense campaign in protest.
One trade group has already filed a lawsuit to try to reverse the decision. Meanwhile, a similar fight over Novo Nordisk’s wildly popular drugs Ozempic and Wegovy looms.
Semaglutide, the active ingredient in both drugs, remains on the FDA’s shortage list, but compounders are bracing for when it isn’t — which could come at any time.
They argue that even though the FDA declared the shortage over, patients still have a hard time finding the drugs. That could mean some significant negative consequences, especially if patients who have been taking the drugs suddenly can’t get them anymore.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a press briefing that “a lot of patients have been left flat footed” by the FDA ending the shortage.
Some patients who have been using tirzepatide may be directed to take semaglutide. But others are going to need to be transitioned to the FDA-approved drug Mounjaro or Zepbound, Brunner said.
“In many instances, it's going to take some time. They've got to get in to see their prescriber, they need to have a discussion with the prescriber about whether the FDA-approved drug is indeed the right medication for them.”
