The choice by the U.S. Food and Drug Administration (FDA) to take tirzepatide off the list of drugs that are in short supply has caused a lot of legal, regulatory, and market changes. Tirzepatide, which is sold as “Mounjaro” for diabetes and “Zepbound” for weight loss, was once thought to be seriously in short supply because demand was so high. However, as of October 2, 2024, it was said to be readily accessible. But this decision has not been made without controversy, which has led to court challenges and makes the future of regulations for compounders uncertain.
After ensuring that the production levels could meet national demand with the manufacturer, Eli Lilly and Company, the FDA decided in October 2024 that the shortage of tirzepatide was over. Even so, there may still be problems in certain areas as the product goes through the supply chain.
When the agency ruled, the Outsourcing Facilities Association (OFA) and North American Custom Laboratories (a 503B outsourcing facility) sued. The plaintiffs say the FDA moved without reason and didn’t do anything about the persistent problems in the supply chain or the patient complaints about access. The case also says the FDA broke the Administrative Procedures Act (APA) by issuing what the plaintiffs call a substantive rule without following the right steps.
The FDA then sent a Motion for Voluntary Remand, asking for a second look at the ruling because of these problems. Enforcement discretion for 503B compounders stays in place during this reevaluation. This means they can compound tirzepatide until at least November 21, 2024.
What the rules say about 503A and 503B compounders
When tirzepatide was taken off the FDA’s list of drugs that are in short supply, it had a big effect on compounding pharmacists who work under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act.
503A Compounding Drug Stores
503A compounders can only make medicines for specific patients based on a prescription. They can’t make drugs that are “basically copies” of FDA-approved products unless they meet strict criteria. The FDA clarified that enforcement discretion would also apply to sterile compounders in general, but 503A pharmacies are still not sure what their status is during the reevaluation time.
503B Facilities for Outsourcing
Facilities that make more blended medicines (503B facilities) are closely monitored. They can’t make drugs that are the same or very similar to FDA-approved goods unless those drugs are still on the shortage list. The FDA’s temporary strategy of not enforcing it gives 503B facilities some breathing room, but this could end soon after the agency finishes its review.
Lawsuits and opposition from the industry
The fact that OFA and North American Custom Laboratories sued the FDA shows how important the case is. The plaintiffs say that the FDA depended too much on manufacturer assurances and didn’t look into ongoing problems like supply chain bottlenecks enough. Concerns in the pharmaceutical business about how the FDA handles drug shortages and finds a balance between patient access and regulatory oversight can be seen in this lawsuit.
At the same time, drug companies like Novo Nordisk and Eli Lilly are stepping up their attempts to stop GLP-1 drugs from being mixed with other drugs. Novo Nordisk, for example, has asked the FDA to put semaglutide on the Difficult to Compound list because of safety worries about how complicated the drug is. These moves show that the competition for market control is getting tougher between companies that make brand-name drugs and pharmacies that make compound drugs.
Tirzepatide isn’t the only GLP-1 drug that the government is after. The drug semaglutide, sold under the brand names Ozempic, Wegovy, and Rybelsus, has been on the FDA’s shortage list for more than two years, and there are currently efforts to stop anyone from making it. Manufacturers say that GLP-1 drugs are too complicated to be safely compounded. However, critics see these actions as an attempt to stop compounders from competing.
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