38 Attorneys General Urge FDA to Offer Protection From Fake Weight Loss Drugs
The counterfeits pose a risk of ‘serious side effects’ to users, potentially leading to hospitalization, the attorneys general warned.
www.theepochtimes.com
The U.S. Food and Drug Administration (FDA) must act to protect Americans from fake versions of GLP-1 weight loss and diabetes drugs such as Ozempic and Mounjaro and take “decisive action” against bad actors engaged in such trade, a letter from a bipartisan coalition of attorneys general from 38 U.S. states said.
“My fellow attorneys general and I are urging the FDA to protect consumers from the growing threat posed by adulterated or counterfeit versions of these drugs,” California Attorney General Rob Bonta, a signatory of the letter, said in a Feb. 20 statement.
“From inspections to enforcement actions, the FDA has several important tools at its disposal to help put an end to this unlawful and deceptive conduct. A federal response is necessary because many of the counterfeit drugs are shipped from outside of the country.”
The bilateral letter, issued a day earlier, said that demand for GLP-1 medications such as Mounjaro, Zepbound, Ozempic, and Wegovy has “skyrocketed.” The high costs of these medications and supply shortages “have created opportunities for wrongdoers to cash in and endanger consumers,” it said.
Fake GLP-1 drugs have entered the U.S. supply chain from nations such as China, Turkey, and India, the attorneys general said.
“These counterfeits can contain contaminants, other unknown drugs, or dangerously high amounts of active ingredient(s). Scammers have also repackaged injectable insulin and falsely sold it as Ozempic,” they said.
Injecting counterfeit drugs “can lead to serious side effects for consumers, sometimes necessitating hospitalization,” the letter said, adding that most consumers cannot identify fake from legitimate variants.
The letter raised the issue of retailers illegally selling active ingredients of GLP-1 medications directly to consumers online without any prescriptions. These active ingredients come from unregulated sources and pose a risk of contamination, it said.
Consumers use the ingredients to formulate drugs without adequate knowledge of safely dissolving the active ingredients, drawing it into syringes, and then injecting the substance into the body, the attorneys general wrote.
There are also compounding pharmacies that produce GLP-1 medications on their own, with some choosing to “cut corners” in pursuit of profits, the letter says. Last year, Eli Lilly and Company, the manufacturer of Mounjaro and Zepbound, said it had identified compounded drugs that have “safety, sterility, and efficacy problems.”
“Some have contained bacteria, high impurity levels, different colors (pink, instead of colorless), or a completely different chemical structure than Lilly’s FDA-approved medicines,” the company said.
Novo Nordisk, which manufactures Ozempic and Wegovy, has filed lawsuits against several pharmacies, weight loss clinics, and medical spas in multiple U.S. states for selling compounded drugs claiming to contain semaglutide, the active ingredient in Wegovy and Ozempic.
The letter called on the FDA to “work with federal partners like the Department of Homeland Security to intercept counterfeit GLP-1 drugs before they reach unsuspecting consumers.”
It asked the agency to send warning letters to sellers supplying active ingredients directly to people and “follow up with enforcement action if companies continue to act unlawfully.”
“The FDA should also ramp up enforcement against any compounding pharmacies that may be illegally participating in this market,” the attorneys general wrote. “The FDA must work in partnership with state pharmacy boards to ensure compounded GLP-1 drugs are produced in a safe, sanitary way.”
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