Novo Nordisk, the Danish-based manufacturer of Ozempic, has reported that 10 people died and 100 more were hospitalized after taking substandard copies that are not subject to the strict oversight and safety standards of brand-name medications. This in part because Biden’s FDA has been lax in enforcing penalties on commercial compounding facilities that produce substandard knockoffs. But it’s also because the chemicals used to produce these knockoffs are imported from China and other foreign nations without oversight or regulation.
The new administration has an opportunity to help millions of Americans get healthy while modernizing our manufacturing processes and shoring up an important component of our national security. New obesity medications, known as glucagon-like peptide-1 (GLP-1) agonists, not only help people lose weight and keep it off; they also reduce the risk of heart attacks, strokes, diabetes, and other chronic diseases. And there is growing evidence that they can help people break addiction to alcohol, nicotine, and potentially even opioids.
While these benefits have fueled extraordinary demand, health insurers have balked at covering the medications for many people who need them. Earlier this year, FDA declared a shortage of GLP-1s, which opened the door for compounding pharmacies to legally produce and sell knock-off versions. FDA has long allowed licensed pharmacists to compound drugs to meet specific needs of the patients they serve and produce drugs when in shortage. But this discretionary permission has been abused by big businesses trying to replicate weight loss medications by mixing and matching ingredients, predominantly using chemicals imported from China. They claim their products provide the same curbed appetite, reduced weight, and other health benefits, but the reality is these products are manufactured and sold to consumers without FDA oversight.
Compounding pharmacies do not have to notify or receive agency authorization, nor does FDA review the final product for safety and efficacy. This is why the agency warns on its website, “Unnecessary use of compounded drugs may expose patients to potentially serious health risks. For example, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much or too little active ingredient. This can lead to serious patient injury and death.”
Last year, poison control centers across the country reported spikes in calls related to overdoses of anti-obesity medications. Authorities attributed the problem to the fact that compounding pharmacies were using different doses than those established by the drugmakers through the regulatory approval process. As of August 31, FDA reported receiving nearly 500 reports of adverse events related to compounded anti-obesity medications.
Novo asked FDA to ban U.S. compounding in October, noting that knock-off drugs it studied were sold with the wrong dosage strengths and contained impurities. But the agency refused to take action, squandering FDA’s opportunity to lead. While the brand-name medications are no longer in shortage, expanding coverage for anti-obesity medications through Medicare without reforming our regulatory policies will only exacerbate existing problems.
Dr. Marty Makary, Trump’s pick to head the FDA, should use Medicare’s expansion to call for modernizing U.S. manufacturing techniques, ensuring that chemical inputs for all medications including obesity medications come from reliable sources, and strengthening the supply chain. In the meantime, it should also designate GLP-1s “too difficult to compound.” This would give brand-name drugmakers the legal backing they need to shut down illicit compounders, protect consumers, and restore confidence in safe obesity medications.
Doctors and consumers have a role to play, too. A study from the nonprofit Kaiser Family Foundation found that approximately one in eight American adults—roughly 13 percent of the population—have taken GLP-1s. The prescription and use of obesity medications for cosmetic purposes is not backed by science. It undermines the regulatory process and needlessly puts people at risk by fueling a dangerous black-market environment where unscrupulous actors can cut corners to make a quick buck.
As more studies confirm the health benefits of these medications, private insurers will need to provide broader coverage too. Chronic disease accounts for over 85 percent of our nation’s health care costs. Safe, affordable obesity medications will be essential to reducing these costs and making America healthy again.
Joseph Grogan is a Nonresident Senior Scholar at the USC Schaeffer Institute and served as director of the White House Domestic Policy Council under President Donald J. Trump, 2019-20. He has also served as the Associate Director of Health Programs at the Office of Management and Budget. He consults for pharmaceutical companies. His speaking engagements are managed by Worldwide Speakers Group.
The views expressed in this article are the writer’s own.
