According to Ronald Reagan the scariest phrase in the English language is “I’m from the government and I’m here to help.” But when regulators neglect to enforce laws already on the books, it’s the American people who pay the price.
Case in point: the FDA’s failure to stop illegal, unsafe and unregulated mass-compounded, knock-off versions of GLP-1 drugs (medicines like Ozempic and Wegovy used to treat diabetes and obesity). These FDA-approved drugs have passed rigorous safety and efficacy protocols, and their manufacturing is carefully regulated. Their mass-compounded imitators? Not at all.
Legitimate compounding pharmacies play an important role in healthcare. They serve individual patients with demonstrated unique medical needs that can’t be met by FDA-approved medicines. Compounders hawking their wares across the internet, advertising in leading publications, and even placing ads during the SuperBowl aren’t compounders at all – they are unregulated pharmaceutical companies aggressively marketing unapproved GLP-1 drugs at scale, using uninspected imported, ingredients from anonymous foreign facilities, many in China. That’s not healthcare. It’s anarchy.
These compounders are flagrantly violating federal laws. Meanwhile, the FDA has largely looked the other way. What began as a stopgap during a temporary shortage has morphed into a dangerous flouting of the law, as these “corporate compounders” continue to produce, market, and sell their substandard GLP-1 drugs in mass quantities, even though there is no longer any shortage, using phony “personalization” claims—like adding an untested vitamin or tweaking a dose—as a legal fig leaf to keep the cash rolling in.
This ends badly. In 2012, the New England Compounding Center’s contaminated drugs killed over 100 people and sickened hundreds more. Congress responded by strengthening compounding oversight. But without enforcement the FDA is just a paper tiger.
Those who do not learn from history are bound to repeat it. Patients using compounded GLP-1s are over twice as likely to end up in the hospital compared to those using FDA-approved products. Poison control centers reported a 1,500% increase in GLP-1 overdose calls in recent years, many due to confusing labeling and inaccurate dosing on compounded products.
This isn’t just a health crisis. It’s a burgeoning national security issue, a trade problem, and a textbook example of regulatory neglect.
The consequences extend far beyond today’s headlines. GLP-1 drugs are now being studied to treat everything from heart failure to drug and gambling addiction, to Alzheimer’s disease. But this research—and the American patients who could benefit from it—are at risk if legitimate manufacturers pull back due to unchecked fraud in the marketplace. If law-abiding manufacturers can’t trust the FDA to protect their patented, approved medicines from unsafe and illegal knockoffs, why should they invest billions in the next breakthrough?
What’s the solution?
Congress and the FDA already have the tools to fix this. What’s lacking is the will. The FDA must enforce the law—no more excuses, no more delays.
- Compounders acting like manufacturers should be regulated like manufacturers.
- Illicit foreign ingredients must be stopped at the border.
- Congress must ensure the FDA has the resources to enforce the laws on the books, including long-ignored limits on interstate shipments.
Regulatory overreach? Hardly. It’s enforcing the law as Congress wrote it—applying existing limits on compounding, defending lawful commerce, and protecting American families from the dangers of backdoor drug manufacturing.
Shame on the FDA if it waits for another disaster to act. Let’s not learn the hard way what it means to let standards slip. As Otto von Bismarck said, “Only a fool learns from his own mistakes. The wise man learns from the mistakes of others.”
We already know how this ends if we fail. Now is the time to choose a different path.
Peter J. Pitts, a former FDA Associate Commissioner is President, Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.
