FDA: Tirzepatide Shortage Is Over, GLP-1 Supply Is Stabilizing
Are we indeed reaching the end of the on-again, off-again supply shortage for GLP-1 obesity medicines? That seems to be what FDA signaled yesterday. The agency posted a brief statement, not only noting its determination that the tirzepatide shortage is “resolved,” but also saying the national GLP-1 supply has begun to stabilize. FDA is looking at the possibility of removing semaglutide from its status in shortage, too.
Maybe we are at the end of this years-long shortage. Perhaps the flourishing GLP-1 compounding business will dry up and disappear. Or maybe not. CEO Scott Brunner of the Alliance for Pharmacy Compounding said yesterday:
“FDA’s announcement this morning may not be the end of the story. Though the agency is doubling down on its October 2 shortage resolution, there’s still litigation out there. Today’s statement from the agency certainly informs that litigation, but it’s not a decision by a court.”
A Pause and a Grace Period
For the moment, nothing will change. FDA has put compounders on notice that the agency will not take action against compounders right away. For state-licensed pharmacies FDA will not enforce a ban on dispensing tirzepatide before February 18. For outsourcing facilities, the grace period will go until March 19.
The litigation against FDA by the Outsourcing Facilities Association will remain paused until at least January 2. Both the FDA and the OFA are due to update the court again then. OFA says it does not plan to simply drop its objections to FDA actions on this matter.
“Intermittent Challenges“
In declaring the tirzepatide shortage to be over, FDA is not saying that the drug is flowing freely to everyone who needs it. The agency acknowledges “intermittent challenges” patients face in getting their drugs. FDA also notes that many people getting tirzepatide from compounders may increase the demand that Lilly faces. But they say there’s no evidence Lilly can’t meet the demand.
We will be watching. Will the litigation and the compounding business fade away? Will semaglutide come out of shortage next? None of this is certain.
But our most confident prediction is that everyone who needs a GLP-1 agonist will not gain access in the near future. Tremendous unmet medical need is in tension with supply, demand, price, and insurance coverage. That tension will take years to resolve.
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Baffled Scientists, photograph by Nutsinee Kijbunchoo, licensed under CC BY 4.0
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December 20, 2024
