FDA lends a hand to Novo, Lilly on illegal GLP-1 imports

The FDA has set up a 'green list' of overseas sources for weight-loss ingredients in an attempt to block illegitimate and potentially unsafe supplies entering the US market.

The list identifies sources of GLP-1 active pharmaceutical ingredients (APIs) from plants that operate in compliance with the FDA's standards for manufacturing practices – based on an inspection or other oversight by the agency.

In principle, APIs from other sources will be flagged with an alert that can prevent non-compliant shipments from being imported into the US by giving border control the authority to seize them without inspection.

If effective, the move could be a major help to Novo Nordisk and Eli Lilly, which are battling to prevent widespread production of rival versions of their obesity therapies by compounding pharmacies in the US.

Compounded versions of Novo Nordisk's GLP-1 agonist Wegovy (semaglutide) and Lilly's dual GLP-1/GIP agonist Zepbound (tirzepatide) were launched – perfectly legally – while the two drugs were still on the FDA shortages list.

While no longer in short supply, meaning that compounding should no longer be possible, some companies have continued to provide the drug to patients under exceptions for 'personalised' treatments.

That allows them to make compounds in small quantities for patients whose needs are not met by a standard formulation, although, that interpretation of the rules is being challenged in the courts.

A huge number of companies have sprung up to satisfy the massive demand for GLP-1 agonists, whose ability to help people shed weight quickly has transformed the obesity market and made many people prepared to pay for the shots out of their own pockets. Interrupting the supply of the APIs used in producing the jabs could make it much harder for compounders to meet that demand.

"This action will help protect consumers from receiving poor-quality compounded drugs containing foreign-made APIs […] that may be manufactured without appropriate controls to assure quality," said the FDA in a notice introducing the green list.

The regulator stressed that it will not stop the legal importation into the US market of GLP-1 APIs from compliant manufacturers, or introduce limits on compounding of GLP-1s, provided it is being carried out legally.

It has identified serious concerns with compounded versions of semaglutide and tirzepatide, including dosing errors, use of unapproved salt forms, and adverse events that in some cases have put people in hospital.

"Americans should be confident that the prescription drugs they take are safe," said FDA Commissioner Marty Makary.

"By strengthening oversight of imported APIs and cracking down on illegal drugs entering the US, we are taking aggressive action to protect consumers from poor-quality or dangerous GLP-1 drugs."

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