US Food and Drug Administration Commissioner Dr. Robert Califf said on Wednesday that he is very concerned about the prevalence of compounded and fake versions of highly in demand new weight loss drugs online.

Consumers seeking these medicines are attracted to compounded versions that are sold without proper controls to ensure they get the right active drug, Califf said in a Reuters Newsmaker interview.

“In the context of the total picture of illicit drugs being sold on the internet, it’s almost certainly bigger than, much bigger than what we see,” he said of such reports to the agency.

Demand has been far outpacing supply with some analysts forecasting the market for weight-loss drugs, currently led by Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound and Mounjaro, could reach $100 billion a year by the end of the decade.

Earlier this month, the FDA sent warning letters to two online vendors for selling unapproved and misbranded versions of semaglutide and tirzepatide, the active ingredients Wegovy and Zepbound, respectively. Counterfeit versions of diabetes drug Ozempic, which has the same active ingredient as Wegovy and has been used off label for weight loss, have sent people to the hospital with dangerously low blood sugar.

Califf said he is also concerned about the “enormous disparity” between people who can access the potent new drugs based on wealth or connections to the medical community, and those who do not have those advantages but might have a greater need for the treatments.

Wegovy and Zepbound both have retail prices of over $1,000 a month. Only about a fifth of employers covered prescription weight loss therapies as of last March, according to the International Foundation of Employee Benefit Plans, meaning many patients would have to pay full price.

Asked about drug research areas not getting enough investment, Califf pointed to a lack of development of medicines to treat mental health issues.

He also said more research was needed for medicines to treat chronic lung diseases, which he said was a fast growing cause of shortened life expectancy.

Concerns about unregulated and counterfeit medicines are not limited to weight loss drugs.

“I’m taking four generic drugs for my hypertension and elevated cholesterol ... and if I got a drug that was half as potent as I thought it was, I could have a heart attack, never knowing that I didn’t get the treatment that I thought I was getting,” said Califf, 72, now in his second stint as FDA chief.

“The cough syrup catastrophe, which didn’t affect the US but killed a number of children in Asia [and Africa], really called attention to the problem,” he said.

Indian-made cough syrups have been linked to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon since 2022, a blow to the image of the world’s third largest drug-manufacturing country after the United States and China.

A court in Uzbekistan sentenced 23 people to prison terms on Monday over the deaths of 68 children linked to contaminated cough syrups produced by India’s Marion Biotech.

Califf said he had spent much time in India during his academic days and has a number of connections with the government there.

“There’s a lot of goodwill right now in terms of fixing the problems that we’ve seen,” he said, adding that these problems are not just in India.

The FDA has increased inspections of manufacturing facilities outside of the United States, he said. A big proportion of starting materials and chemicals used to make drugs come from China, while much of the manufacturing of the finished product takes place in India, Califf said.

“There is an industrial policy and national security question; do we want to bring more of this into a secure supply chain, either onshore or near shore? I think the answer to that is yes,” he said. “The question is how much and how do you do it?”

Reporting by Caroline Humer; Writing by Ahmed Aboulenein; Editing by Bill Berkrot

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