A bipartisan group of congressional lawmakers is calling on the Trump administration to address the continued sale of illicit, compounded GLP-1 products, warning that consumers may be accessing these drugs without knowing the product could be fraudulent.
North Carolina Reps. Brad Knott (R) and Deborah Ross (D) wrote to Food and Drug Administration (FDA) Commissioner Marty Makary, Homeland Security Secretary Kristi Noem and U.S. Attorney General Pam Bondi, imploring them to end the sale of “counterfeit, research-grade and illegal copycats” of popular GLP-1 medications.
When the commercial, branded versions of tirzepatide and semaglutide were declared to no longer be in shortage, compounding pharmacies were disallowed from continuing to sell compounded versions of those drugs.
While telehealth companies have transitioned away from compounded versions, state officials have warned that “copycat” drugs have proliferated in the months since the shortages ended. Earlier this year, the National Association of Attorneys General sent a letter to the FDA to warn that “counterfeit GLP-1 drugs have infiltrated the U.S. supply chain from China, Turkey, India, and other foreign sources.”
According to the attorneys general, online retailers sell the active ingredient for the GLP-1s under the claim that they’re “for research purposes only” or “not for human consumption” while still marketing them to consumers on social media.
The FDA issued a warning in April, telling consumers to not take counterfeit Ozempic. The drug’s manufacturer, Novo Nordisk, had alerted the agency that several hundred units of counterfeit product had entered the U.S. supply chain. At the time, the FDA said it was aware of six adverse events associated with the counterfeit products.
Though the FBI issued a public service warning soon after the letter from the attorneys general was sent, Knott and Ross said raising public awareness wasn’t enough.
“FDA has received hundreds of reports of adverse events, even some resulting in the hospitalization and death of patients who used illicit GLP-1s,” they wrote. “This is likely a significant underreporting of adverse events experienced by patients because federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA.”
The lawmakers asked that the Trump Cabinet members fully use “the legal tools at your discretion” to further detect illicit and enforce U.S. drug standards.
Sen. Thom Tillis (R-N.C.) sent his own letter to Cabinet members, calling for enhanced collaboration among agencies like FDA, U.S. Customs and Border Protection and the Justice Department in order to stop the counterfeit products from reaching the supply chain in the first place.
The Hill has reached out to the agencies named in the letter for comment.
