Last month, the United States Food and Drug Administration (FDA) issued more than 50 warning letters to online sellers of compounded versions of GLP-1 drugs used for Type 2 diabetes and weight loss. The agency alleged that certain marketing language constituted the “unlawful sale of unapproved and misbranded drugs” and ordered companies to immediately remove the cited language from their advertisements. These letters mark the FDA’s first large-scale action targeting the enormous GLP-1 market, where compounding pharmacies have filled gaps left by product shortages of brand-name drugs from Novo Nordisk and Eli Lilly.
Background
GLP-1 drugs were originally approved for diabetes but later gained separate FDA approvals for weight loss under new brand names and codes. These approvals allowed insurers to cover only the diabetes versions. Both brands’ prices are near or above $1,000 per month.
High demand led to FDA-declared shortages in 2022, allowing compounding pharmacies to legally produce temporary versions for patients. Many sold these compounded alternatives for a fraction of the price of branded versions.
Once the shortages ended, the FDA gave pharmacies and compounding facilities a defined period to wind down production. Some complied, while others continued under the “clinical need” exception, prompting brand manufacturers to send cease-and-desist letters and file lawsuits.
What Triggered the FDA’s Letters
The FDA requires that all drug advertising be truthful, balanced, and not misleading. Since compounded drugs are not FDA-approved, they cannot be marketed as safe or effective. Other issues the FDA flagged in the advertising included using “FDA-approved” or similar phrasing that implied approval and comparing the compounded product to the branded product or calling it a “generic” or “equivalent” of the same.
Outlook and Enforcement Uncertainty
The FDA has signaled a broader enforcement focus based on accurate claims, but guidance on compounded drug advertising remains limited, leaving sellers uncertain about compliance standards. Compounders should scrutinize their advertising for statements that potentially run afoul of the FDA’s limited guidance on this issue.
