WASHINGTON, D.C. – Today, the CONSUMER CHOICE CENTER (CCC) released a new policy primer titled GLP-1 Agonists, Intellectual Property, and the Hidden Dangers of Compound Drugs to American Consumers, documenting how copycat [compounded] GLP-1 products are putting patients and public health gains at risk.
GLP-1 medicines have been transformative for patients living with diabetes and obesity—conditions that together impose staggering costs on Americans and the wider economy. The report highlights the public-health and economic stakes, warning that a growing shadow market of compounded look-alikes is exploiting loopholes and confusing consumers.
“Patients fighting back against obesity and all its known comorbidities deserve safe, accountable, and effective treatments—but knockoffs with unknown impurities including toxic heavy metals and formaldehyde are still flooding the market,” said Fred Roeder, Managing Director of the Consumer Choice Center and co-author of the report, “The FDA has the authority to stop this and should use it now by intercepting suspect ingredients and enforcing registered-supplier rules. There have been 1,424 incidents of harm done by compounds, 329 hospitalizations, and 23 deaths. This can’t be allowed to continue.”
Authored by Fred Roeder and Emil Panzaru, this new GLP-1 report drives home the importance of a responsible approach to curbing obesity in the United States, which is reported to cost the U.S. economy almost $1.4 trillion every year.
“FDA-approved weight-loss drugs are one of the most profound innovations of the century, with the most visible positive effects on patients we’ve ever seen, and protecting those gains is an actual life and death matter for so many people wrestling with stubborn weight issues and diabetes,” added researcher Emil Panzaru.
CORE POLICY RECOMMENDATIONS
CCC lays out atleast three action items that federal regulators should take in the near term
- INTERCEPT high-risk shipments of illicit APIs at the U.S. border and ENFORCE the requirement that key ingredients come from FDA-registered manufacturers.
- ESTABLISH U.S. Pharmacopeia monographs and drug master files as reference standards for compounded semaglutide.
- REQUIRE that any compounded product be identical to the reference-listed drug to safeguard patient health.
