Compounding, Generic Drugs, and Dietary Supplements
In the U.S., we are at a critical point for the sourcing obesity medicines. March 19 was the last day that FDA would tolerate large scale compounding of tirzepatide on account of the now resolved shortage of that drug. The same milestone for semaglutide is coming up on May 22. Some people are not happy. They say that these options come at a price that puts them within reach – cutting the cost by as much as two-thirds. For perspective, let’s take a look at the parallels between compounding these drugs and the regulatory history of generic drugs and dietary supplements.
Generic drugs and dietary supplements followed different paths that offer insights about what might happen as FDA tries to regulate compounding of GLP-1 medicines.
Making Generics Respectable and Accessible
Generic drugs are bioequivalent alternatives to their brand-name counterparts. They face rigorous scrutiny from FDA to assure quality and safety. This is true because of the Hatch-Waxman Act of 1984, which established a clear pathway for the approval of generic drugs, ensuring they meet high standards for safety, efficacy, and quality. That regulatory framework promotes competition, lowers costs, and increases accessibility to medications.
Before Hatch-Waxman, the pharmaceutical industry had a measure of success over many years in resisting price competition – even after patents on their drugs expired. They used fear, uncertainty, and doubt to make doctors and patients hesitant to trust generics. Hatch-Waxman put an end to most of this.
The Wild World of Dietary Supplements
In contrast, dietary supplements operate under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which significantly reduced the FDA’s authority over these products. Unlike drugs, supplements do not require premarket approval, and manufacturers are responsible for ensuring product safety and labeling accuracy. Regulatory action is typically reactive, occurring only when safety concerns arise. This leniency has led to variability in product quality and very little consumer protection.
It happened because of the supplement industry mounting a campaign with consumers demanding that FDA keep out of regulating dietary supplement. “Don’t take away my vitamins!” was the rallying cry.
The Gray Zone of Compounding
The compounding of GLP-1 agonists exists in a regulatory gray area. Compounded drugs are generally prepared by licensed pharmacists or physicians to meet the specific needs of individual patients when FDA-approved options are unavailable or unsuitable. FDA permits compounding under certain conditions, but it prohibits the production of large-scale compounded drugs that replicate commercially available products.
But the shortages of semaglutide and tirzepatide opened the door for compounding pharmacies to step in and meet demand. Under current law, FDA had to tolerate it despite concerns about product quality, consistency, and patient safety.
A Turning Point
Will FDA adopt an aggressive stance with compounders? Will pharma act aggressively to improve the access to their patented medicines? Will health insurance put these high quality medicines further out of reach by further tightening restrictions on coverage?
Patients have an urgent medical need for these medicines. Health insurers, pharma, and government regulation have not done enough to make sure that people can get them. So patients take risks with dodgy offerings and sometimes become victims of fraud and dangerous products.
Government, health insurance, and pharma all have a duty to do more and solve this problem.
Click here for more on the story of generic drugs, here for the supplement saga, and here more on issues with compounding of obesity medicines. For excellent perspective from Joe Nadglowski at the Obesity Action Coalition, click here.
Joe’s Generic Bar, Austin, TX, photograph by Jmabel, licensed under CC BY-SA 3.0
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March 26, 2025
