In a reversal, the FDA is reconsidering its decision to end the shortage status of tirzepatide, after a recent lawsuit and intense public pressure, The Washington Post reported Oct. 21.
The move allows compounding pharmacies to temporarily resume selling cheaper, unbranded versions of the drugs while the FDA continues to assess whether a shortage exists. The FDA's shift follows widespread confusion among patients and pharmacies, with many patients unable to afford the branded drugs and relying on the compounded versions.
After the FDA initially declared the shortage over on Oct. 2, compounding pharmacies were forced to stop production, leading to panic among patients who depend on these drugs for weight management.
Compounding pharmacies and their patients had been alarmed by the FDA's announcement, and the Outsourcing Facilities Association, a trade group of compounders, filed a lawsuit Oct. 11. Following the lawsuit, the FDA said it would reassess the shortage and would not enforce a ban on compounded versions.
Although the FDA had said Eli Lilly could meet national demand, patients and healthcare providers have reported difficulties in obtaining the drug, prompting criticism of the agency's oversight.
The FDA and the compounding industry must file a joint status report by Nov. 21.