Discount Diet Drugs Will Test FDA’s Ability to Enforce Laws
COMMENTARY
It’s hard to watch television or scroll social media without seeing an advertisement for a discount diet drug. These diet treatments are knockoffs of brand-name GLP-1 drugs, like Zepbound and Ozempic, of which there is a shortage.
To manage the national shortage of GLP-1 drugs, last year the Food and Drug Administration authorized the sale of “compounded” versions of these patented diet medications to the American public. Understand, these “compounded” versions of the drugs are not identical to the brand-name products. They are only similar combinations of the same ingredients. The FDA also does not guarantee the safety of these drugs, only that they are produced in facilities that are FDA compliant.
Today, consumers can buy GLP-1 “gummies.” But to be effective, these drugs need to be injected, not eaten. So, people are throwing money down the drain to buy these worthless edible products. Yet this is all lawful.
To understand how we got here, Congress passed legislation in 2013 to improve rules for compounding drugs in response to a batch of such drugs that gave patients fungal meningitis, killing more than 60 people and making many gravely ill. Known as the Drug Quality and Security Act, this law allows drug makers to compound or copy FDA-approved drugs if they are on the FDA’s shortage list.
Late last month, the FDA declared that the shortage of GLP-1 diet drugs was over, and that the compounded versions of these diet drugs would only be available to customers for 60 or 90 days to prevent people from running out of their treatments.
But now we have a problem. Many of these companies plan to keep selling the compounded products regardless of the FDA declaring the shortage is over. Some companies will go to court to challenge the FDA’s order ending the sales of these compounded medications. A federal judge just ruled against the compounders, blocking the sale of the compounded version of Eli Lilly’s popular weight-loss and diabetes drugs. But this court ruling will not resolve the matter.
Other compounding companies may use something akin to loopholes in the Drug Quality and Security Act. They will tweak the drugs formulas — so that the compounds are different enough from the brand-name drug — to continue sales.
Worse, other companies selling these compounded drugs may just figure that the FDA doesn’t have the time, staff or willpower to go after the violators. Who can blame them, as our president and Elon Musk are working to disrupt and fire hundreds of thousands of government employees?
To remedy this situation, Congress needs to step in and give the FDA the ability to punish businesses that continue to market these discount diet drugs after the FDA says the shortage is over and their sale is no longer allowed.
And President Donald Trump can help address this problem by continuing a policy approved by President Joe Biden, one that gives people on Medicare and Medicaid access to discounts on brand-name GLP-1 medications. This policy makes sense because it ensures that the brand-name drugs are not available only to wealthy Americans.
After all, you shouldn’t have to be rich to be healthy.
Ultimately, the continued sale of discount diet drugs, even after the FDA says it is no longer legal to sell them, is likely to be a real-time stress test of the agency’s capabilities.
Until Congress acts decisively, laws surrounding compounded drugs may be flouted, and there is little we can do about it.
Hank Naughton is a former judge, Massachusetts legislator and current president of the Centrist Democrats of America. Naughton can be reached by email.
