The Latest in Legal for GLP-1s

This post was originally published in The Aesthetic Guide on May 13, 2025

What's happening with GLP-1s?

Over the past few years, glucagon-like peptide-1 (GLP-1) receptor agonist weight-loss drugs have surged in popularity across the United States and the world. Initially dubbed the “skinny shot” after gaining celebrity attention in the early 2020s, these medications, namely semaglutide (Ozempic® and Wegovy®, Novo Nordisk) and tirzepatide (Mounjaro® and Zepbound®, Eli Lilly and Company), have cemented their place as powerful tools in the fight against obesity and weight-related chronic diseases. 

Due to drug shortages, access to GLP-1s for many patients has come in the form of compounded injections prepared by specialty pharmacies using the active pharmaceutical ingredients (APIs) semaglutide or tirzepatide. But as the U.S. FDA has resolved drug shortages and removed these APIs from its official shortage list, the legal status of compounded versions has become more uncertain, setting off lawsuits, pharmacy closures and even political involvement from figures like Robert F. Kennedy, Jr., the current U.S. Secretary of Health and Human Services under the Trump administration. 

Here’s what you need to know about how we got here and what happens next for patients, providers and compounders. 

How the FDA Shortage List Works

The FDA maintains a drug shortage list that determines whether certain medications can be compounded by pharmacies. Generally, under the Food, Drug, and Cosmetic Act (FD&C Act), manufacturers hold exclusive rights to produce the APIs for patented drugs. Pharmacies are typically prohibited from compounding drugs that are considered “essentially copies” of FDA-approved, commercially available products. What is “commercially available” is defined by its absence from the drug shortage list. 

However, when a drug appears on the FDA shortage list, both 503A (state-licensed) and 503B (outsourcing) pharmacies may temporarily compound that drug to help alleviate supply gaps. Since 2022, the demand for semaglutide and tirzepatide has dramatically outpaced supply, leading the FDA to classify both APIs as officially “Currently in Shortage.” Fast forward to Spring 2025, and both the semaglutide and tirzepatide drug shortages are “Resolved.”

Legal Battles for Patient-Compounded Drug Access 

Patients and providers across the country continue to report persistent supply chain issues in accessing GLP-1 medications, with inflated drug prices adding another major barrier to treatment. In response, two federal lawsuits are underway: Outsourcing Facilities Association (OFA) v. FDA I and II.

As of Friday, April 18, 2025, the first OFA lawsuit against the FDA regarding the removal of tirzepatide from the FDA’s drug shortage list is ongoing. Originally filed in October 2024 in the Northern District of Texas, the case is approaching a critical juncture: a closed summary judgment hearing took place Thursday, April 24, 2025. The outcome of this hearing has not yet been disclosed.  

In its summary judgment ruling, the court will determine, as a matter of law, whether the FDA violated the Administrative Procedure Act (APA) by removing tirzepatide from the shortage list without engaging in the required rulemaking process. The OFA argues that the FDA’s action amounted to a new rule with significant implications for 503B outsourcing facilities and, therefore, required a formal notice-and-comment period. The FDA, on the other hand, maintains that the action was an adjudication, not a rulemaking, and thus no public comment was required. 

The OFA’s motion for a preliminary injunction was previously denied and is currently pending on appeal before the Fifth Circuit Court of Appeals. No decision has been issued on that appeal as of this writing. 

A second lawsuit, OFA v. FDA II, raises nearly identical legal arguments in response to the FDA’s January 2025 removal of semaglutide from the shortage list. This case is also pending in the Northern District of Texas. Marti Law Group submitted an amicus brief on behalf of NP2Go, Inc., a telehealth provider powered by nurse practitioners, supporting the Plaintiffs’ Motion for Preliminary Injunction. The Plaintiffs’ Motion for Preliminary Injunction was denied in an opinion that is under seal due to the confidentiality agreement between the parties. The court published a summary judgment briefing schedule but has not yet released a date for a forthcoming summary judgment hearing.  

New Developments: Pricing Mandate and Federal Coverage 

In an interview with CBS News in mid-April, RFK Jr. announced that President Trump had issued a directive to reduce GLP-1 drug prices to match those charged in European countries. The move aligns with the administration’s broader foreign economic policy agenda, especially since both Eli Lilly and Novo Nordisk are based in Europe and offer these medications abroad at substantially lower prices. 

Reports indicate that the cost for a 10-mg dose of semaglutide or tirzepatide is approximately $1,000 to $1,200 per month in the U.S., while in Europe, the same medications can cost as low as $93 in the U.K., $87 in Australia and $83 in France. Elevated U.S. prices place a significant financial burden on uninsured patients or those whose insurance does not cover weight-loss treatments.  

Although President Trump rescinded previous Medicare and Medicaid coverage proposals for GLP-1 medications earlier this year, RFK Jr. noted that the administration is now re-evaluating how these drugs fit into federal payer programs. Currently, Medicare and Medicaid do not cover GLP-1 medications when prescribed for weight loss alone, despite mounting evidence of their long-term health benefits and cost-saving potential. 

Next Steps for Providers

Many providers have recently received demand letters from Eli Lilly and Novo Nordisk concerning the continued dispensing of compounded semaglutide and tirzepatide injections. These letters often allege unauthorized distribution or trademark infringement and may cite the FDA’s recent removal of these drugs from the shortage list. Providers should consult legal counsel promptly, as the timing of the letter and specific allegations will significantly impact the appropriate course of action and potential liability.