ITC says CBP must crack down on illicit obesity drug imports

The International Trade Commission (ITC) has called on US Customs and Border Protection (CBP) to prevent the illicit import of knock-off versions of Eli Lilly's weight-loss drug tirzepatide which may be harmful to users.

In a recent ruling, the ITC found that "multiple bad actors" have been importing or selling knockoff tirzepatide – sold by Lilly as Mounjaro for diabetes and Zepbound for obesity – and were "likely to deceive consumers about the nature and source of their products."

Seven entities – located in China, Spain, Texas, Florida, and Iowa – were found to violate federal law because their conduct was likely to deceive consumers about whether their claimed tirzepatide products were genuine Lilly medicines, and by falsely claiming they had undergone clinical trials, were FDA-approved, or even contained tirzepatide when they did not, said Lilly in a statement. The ruling applies to anyone importing illicit knockoff tirzepatide products.

In December, the FDA removed tirzepatide from the list of drugs subject to shortages, a regulatory status which makes it legal for compounding pharmacies to produce their own versions of a drug on a temporary basis.

That change in status has been challenged in the courts by groups representing compounding sector, including the Outsourcing Facilities Association (OFAC) and FarmaKeio Custom Compounding, which claim that there are continued supply disruptions.

Lilly recently joined the FDA in defending its position in the lawsuit, hoping to block efforts by the compounders to continue making tirzepatide. As it stands, pharmacies and outsourcing facilities are required to wind down production by February 18 and March 19, respectively.

Lilly claims that the availability of compounded tirzepatide and other obesity therapies makes it harder for patients to make sure they are buying a legal version, as the market has been flooded with illicit copies.

"Most people have no idea that the knockoff compounded drugs they are taking may be coming from dangerous and illicit foreign sources," said Patrik Jonsson, president of Lilly USA.

"Knockoff medicines, or the active ingredients they contain, are often produced abroad in unregistered facilities that have never been inspected by any regulatory agency," he added. 

"Sometimes these knockoff medicines – which come from places like China and India – are sold by entities that cannot even legally sell them in their own countries. Lilly has obtained illegal shipments from China claiming to be ''tirzepatide' that are deceptively packaged as dog food, tea, and facial masks or hidden inside of a box of t-shirts."

Meanwhile, it points to evidence that compounded versions may also be unsafe. In November, the FDA alerted patients about tirzepatide products from a licensed California compounder that "used non-sterile ingredients" and "took no steps to sterilise them."