Fake Ozempic is a real worry for NJ lawmaker seeking federal action

🔵 Lawmakers have sent a letter to the FDA about fake Ozempic

🔵 They want more deals about its presence in legit supply chains

🔵 One NJ lawmaker is on the committee requesting a briefing

In December 2023, The Food and Drug Administration found counterfeit Ozempic injection products coming into the United States through a legitimate drug supply.

Thousands of counterfeit Ozempic pens, the diabetes drug often used for weight loss, arrived in a warehouse in Elmira, New York, as early as the fall of 2023, according to several investigative articles.

Those supplies have since been seized but the fact that counterfeit medications made it into the legitimate medical supply chain has raised concerns about potential gaps in the supply chain security infrastructure.

Now, these counterfeit drugs are being sold online. Consumers fill out a questionnaire, provide their credit card information, and then receive a box of powder in the mail. They mix that powder with a saline solution and inject them into their bodies, which can be dangerous if that product is not what it’s purported to be, said U.S. Rep. Frank Pallone Jr., D-N.J., 6th District.

So, a bipartisan group of House Energy and Commerce Committee leaders, one of whom is Pallone, sent a letter to FDA Commissioner Robert Califf requesting a briefing by October 22, 2024, about the presence of counterfeit Ozempic and other semaglutide products in the nation’s medical supply chain.

“We haven’t been able to find out how widespread this is, and to find that out because maybe we want to pass legislation or provide additional funding for enforcement,” Pallone said.

So, the letter asks the FDA to tell the Committee how bad the problem is, he added.
“How much of this counterfeit Ozempic has been seized, what’s the quantity, is it coming from certain facilities, is it going to pharmacies, is it going to clinics, what ports of entry is it coming through,” Pallone explained.

The letter also asks the FDA to describe their findings to date regarding the sources of the counterfeit Ozempic (the country of origin and the name of the manufacturer), whether and how counterfeit Ozempic has been smuggled illegally from abroad, and how counterfeit Ozempic has entered the U.S. supply.

In June, the World Health Organization warned that fake batches of Ozempic were also found in the United Kingdom and Brazil. So, the letter asks the FDA to explain what coordination there has been between the FDA and foreign counterparts related to counterfeit Ozempic.

Other questions in the letter include, “Other than seizures of counterfeit products, what other tools is the FDA using to stop counterfeit Ozempic before it hits the U.S. supply chain?” and “Have those tools been successful?”

The letter and its questions will hopefully give the Committee more data about the sources and nature of the counterfeit Ozempic and how it’s entering the U.S. supply in case they want to take additional enforcement action or provide other legislative and fundraising mechanisms to stop it, Pallone said.

The Energy and Commerce Committee has jurisdiction over the FDA, Pallone said. So, part of their effort is to do oversight to figure out if more needs to be done to help the agency. Do they need more resources to enforce the law? Is the law strong enough in terms of penalties? What are the powers of the FDA to prevent fake Ozempic from coming into the country?

Pallone said the Committee requested a briefing by Oct. 22. From there, the Committee can decide whether to have a hearing or decide whether they need additional funds to hire more people to enforce.

“If we think they don’t have enough power or authority at the FDA to effectively go after these counterfeiters, then we may have to give them additional authority people,” Pallone said.

He warned the public to be aware before injecting themselves with a syringe from an online product. It may not be the real thing, which could put their lives in jeopardy.

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