Fifth Circuit Probes FDA Delisting of GLP-1 Drugs, Impacting Access
Fifth Circuit evaluates FDA's removal of GLP-1 drugs from shortage list, potentially impacting drug access.
Why it matters: The decision could influence legal strategies and patient access to affordable medications by setting a precedent for FDA's regulatory approach to drug shortages.
- FDA removed semaglutide and tirzepatide from the shortage list.
- Compounders argue FDA's removal requires APA rulemaking.
- FDA claims delisting was a factual adjudication based on supply.
- Legal experts emphasize the potential regulatory precedent set.
On March 30, 2026, the Fifth Circuit Court scrutinized the FDA's decision to remove semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) from the drug shortage list, a move that restricts 503B facilities from compounding alternative, lower-cost versions of these drugs.
The Outsourcing Facilities Association and FarmaKeio argue that this action by the FDA effectively prohibits compounding without undergoing the traditional Administrative Procedure Act (APA) notice-and-comment rulemaking process. Andrew Grossman,
By the numbers:
- 30% — projected increase in GLP-1 drugs production by major manufacturers
- 2026-03-30 — court hearing date for the regulatory review
Yes, but: Pharmaceutical giants assert that increased production negates the need for compounding.
What's next: The court's decision could impact future FDA drug shortage policies.