Shabbir Imber Safdar
Seizures. Severe vomiting. Dangerous drops in blood sugar. Death by abnormal blood clotting.
Those are some of the health calamities people have endured by unknowingly taking fake semaglutide, the chemical name for the uber-popular diabetes medicine Ozempic. I fear Coloradans soon could face a higher risk to suffer the same.
The Food and Drug Administration is considering approval of a plan for Colorado to import some prescription medications from Canada, a move that prioritizes cost over safety. The approach reflects some similarities to the one Florida received authorization to adopt earlier this year, but Colorado’s importation wish list includes one glaring addition:
Ozempic.
Colorado wants to seek new sources of semaglutide — just like the millions of people overwhelming the Ozempic supply as the demand for diabetes-turned-weight loss medications surges across the world. Colorado’s potential new permissions to break the domestic regulatory process and welcome foreign sources will increase the chances of transforming counterfeit Ozempic concerns into a full-fledged crisis.
Stay up to speed: Sign up for daily opinion in your inbox Monday-Friday
In recent months, the FDA, the World Health Organization and Ozempic’s manufacturer, Novo Nordisk, have issued warnings about problems with the legitimacy of replica medicines. The FDA said it discovered thousands of counterfeit units of Ozempic in the legitimate supply chain in December, and wasn’t sure if some remained in circulation.
Novo Nordisk, which developed the medicine with FDA approval, alerted customers the fake version reportedly contained insulin glargine — not semaglutide — and had been purchased at a retail pharmacy. The company’s chief executive, Lars Fruergaard Jorgensen, said its leaders are working with authorities in several countries to police counterfeit versions as new reports continue to emerge about potential harms.
The global shortages of these drugs have fueled rising instances of suspected counterfeits, according to the WHO, and FDA head Robert Califf said there are likely more cases of fake anti-obesity medicine sales than reported.
My anti-counterfeiting organization, the Partnership for Safe Medicines, has been following this trend closely. Through our research, we’ve identified 16 countries where fake Ozempic has circulated, including the U.S.
A couple similar drugs have entered the market, but the demand for these products still far outweighs the availability. If the FDA allows Colorado to bypass domestic regulation requirements by importing Ozempic from foreign sellers, it will add to the ways counterfeit options can infiltrate the supply beyond control.
The agency’s traditional process for reviewing, approving and regulating the production of medicines is the global gold standard and so thorough for a reason. Any issues with legitimacy and alteration can create a public health crisis and spark distrust in health care. Thanks to the FDA’s strong oversight, we don’t think twice about whether we’ll receive the medicines our doctors prescribe at the pharmacy counter, and we know experts have vetted the side effects or reactions that may follow.
Breaking this secure supply chain puts Americans at risk. Importing medicines from Canada doesn’t mean patients will receive drugs that originated in Canada. Rather, Canada imports its medicines from manufacturers and wholesalers across the globe. Funneling those imports through a new, untested pathway into the U.S. creates opportunities for counterfeiters to take advantage of gaps in the system. The harrowing stories we’ve heard of counterfeit-induced health scares will become more common as long as Colorado pursues importation and the FDA’s green light encourages other states to try the same.
Further, Canada is not interested in sending medicines to the U.S., as it is rightly focused on maintaining supply for its own citizens. Health officials in British Columbia have banned Ozempic exports to preserve limited stock for the province’s local patients.
It’s not too late to change course, though. Florida’s plan has not gone into effect because the FDA requires additional per-drug approvals, and the agency hasn’t authorized Colorado to move forward, either. There is still time to put safety first.
Rather than promoting channels that compound the counterfeit Ozempic problem, the FDA must take seriously its responsibility to spread awareness and keep patients safe. Doing otherwise risks the most consequential cost of all.
Shabbir Imber Safdar is the executive director of the Partnership for Safe Medicines and hosts the True Crime and Medicine Safety podcast.
