The letters come amid the Outsourcing Facilities Association’s ongoing lawsuit against the FDA over the regulator’s decision to end the shortage for tirzepatide.
The FDA last week issued warning letters against a handful of compounding pharmacies and clinics, flagging violations regarding the promotion and sale of unapproved weight-loss drugs, including copycat versions of the blockbuster therapies semaglutide and tirzepatide.
The warnings, dated December 10, were issued to Prime Peptides, Summit Research Peptides, Swisschems and Xcel Research, all of which were found to be selling compounded GLP-1 treatments that, despite being labelled as for research purposes, were marketed for human use.
The FDA looked through the websites and social media pages of the four companies and found evidence that they were positioning their compounded GLP-1 products “to prevent, treat, or cure disease conditions and/or affect the structure or function of the body,” the regulator wrote in all four warning letters.
Such claims, according to the agency, are in violation of the Federal Food, Drug, and Cosmetic Act, which prohibits the sale of unapproved drugs. “This letter is not intended to be an all-inclusive statement of violations that exist in connection with your products,” the FDA wrote in its warning letters, noting that the companies are responsible for investigating and resolving all violations.
The companies have 15 working days from the receipt of the letters to give the FDA a detailed written breakdown of their corrective actions.
The FDA’s warning letters come as the shortage status of Eli Lilly’s tirzepatide—marketed as Mounjaro for type 2 diabetes and as Zepbound for chronic weight management—remains in limbo.
In October, the regulator formally took tirzepatide out of its shortage database, marking all doses of the drug as available. The move, however, was met with strong opposition from compounders, which sued the regulator under the banner of the Outsourcing Facilities Association (OFA) trade group. In its lawsuit, the OFA said that the FDA’s decision to end the shortage was a “reckless” and “arbitrary” move and could “deprive patients of a vital treatment for type 2 diabetes and obesity.”
In an interview with BioSpace last month, David Rosen, partner at Foley & Lardner, said that the lawsuit “is a precedent in this area.” Prior to the OFA suit, “no one has ever challenged the FDA’s decision to remove a therapy from the drug shortage list.”
The OFA case is still ongoing, with the next court update due on Thursday. In the meantime, the regulator has “agreed to not take action against compounders of tirzepatide until December 19, unless the agency makes an earlier decision on remand,” according to a Leerink investor note issued last month.
It is unclear why the FDA has issued warnings against the four compounders now. In its letters, the regulator wrote that “subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect.”
