Will the FDA's green list end illegal GLP-1 compounding?

Regulatory neglect

Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner, shares the agency's concern about product safety.

However, he questions whether the green list approach will be effective in eliminating the root of the issue: compounders.

"There has been so much regulatory neglect regarding the FDA's oversight of GLP-1 compounding," he said in an interview. The agency's pledge to "continue to work with state regulators, monitor the market and take enforcement actions as necessary" took Pitts by surprise, given its weak track record.

Since the shortage ended, the FDA has updated its compounding website, issued warning letters to companies selling unapproved GLP-1s and clarified its policies through public statements. But these actions appear largely ineffective in deterring compounders from mass-producing GLP-1s under the guise of personalization.

Pitts argued that these efforts have amounted to "regulatory neglect," pointing out that compounders still openly advertise their products on social media and other online platforms with little federal interference.

Enforcement gaps

Pitts reiterated that effective regulatory enforcement requires more than public announcements and regularly updating agency websites.

"It is time for the FDA to step up by contacting these compounders, asking about the source of their API, and confiscating and shutting down their operations," Pitts added.

In Pitts' view, the FDA should be working alongside the Department of Justice to properly enforce compounding regulations and hold noncompliant parties accountable.

"The goal should be zeroing out compounding of these products," he advised. "Together, they need to investigate and seize products. Then, they've got to trace them back and identify everyone compounding and aggressively marketing these illegal drugs."

The green list approach

When asked whether the green list strategy will help prevent the circulation of unapproved GLP-1 knockoffs, Pitts said its success hinges on aggressive follow-throughs.

"If the FDA aggressively works to shut down the illegal importation of GLP-1 APIs, then the green list will have a tremendous impact," he noted. But if the green list ultimately allows certain compounders to continue compounding illegal GLP-1 drugs, then it will fall short of its promise.

"The agency will have to commit serious time and resources and do it right," Pitts confirmed. "Otherwise, nothing's going to happen."

He pointed out that a press release without action erodes confidence in the FDA, indicating that the agency is all talk and no action.

"Now that the FDA has said it wants to seize illegal APIs, it has to go where the product is made, which is compounding facilities," he explained. "By and large, Americans aren’t buying APIs [directly]. Instead, they're purchasing compounded versions, which are then ordered and shipped to their addresses."

The agency's next step is to track down every major compounder marketing GLP-1 products and send inspectors to their manufacturing sites to "seize products, take all their manifests and put them out of business," Pitts concluded.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.