The Food and Drug Administration (FDA) has announced new restrictions on the production of glucagon-like peptide-1 (GLP-1) drugs, prompting significant backlash from independent pharmacy labs, users, and the Alliance for Pharmacy Compounding. The FDA’s move, made in early February 2025, targets crucial ingredients necessary for the production of these popular weight-loss and diabetes medications, which have become widely sought after in recent years.
Independent compounding pharmacies have offered their versions of GLP-1 drugs online for prices as low as $99 per month. In contrast, branded medications like Novo Nordisk’s Wegovy are priced between $149 and $1,350 monthly. The disparity in pricing has led many to view the FDA’s actions as favoring corporate interests over patient access to affordable medication.
One user, who goes by the name Mikeyfairypants on social media, expressed frustration with the FDA’s stance. “I’m on a compounded version of Zepbound, and it’s been a miracle cure for me,” they commented on The Baltimore Sun’s platform. This sentiment resonates with many who feel that the pharmaceutical industry prioritizes profit over patient care.
According to Josh Sharfstein, vice dean of the Johns Hopkins Bloomberg School of Public Health, the role of compounding pharmacies is vital, especially during shortages of essential medications. “Compounding is not legal if the drugs are readily available,” he explained, “but at the same time, people need to be able to afford the medications.” This highlights the complex issue of drug access and affordability in the current healthcare landscape.
Scott Bruner, CEO of the Alliance for Pharmacy Compounding, emphasized that pricing is a critical factor for consumers and healthcare professionals alike. “Compounding pharmacies don’t set their price to undercut FDA-approved manufacturers, but they do end up costing one-quarter to one-fifth of the FDA-approved drugs,” he stated, reinforcing the concern that the FDA’s restrictions could limit affordable options for patients.
The popularity of GLP-1 drugs, originally derived from the venom of the gila monster, has surged since the approval of Saxenda in 2014 and Wegovy in 2021. By 2022, a nationwide shortage of these drugs emerged, with the Kaiser Family Foundation reporting that 12% of Americans were using GLP-1 medications. This shortage opened opportunities for compounding pharmacies to produce their own versions of these medications.
In early 2025, the FDA declared the shortage over, yet companies like Novo Nordisk and Eli Lilly have since initiated aggressive campaigns, including lawsuits, aimed at suppressing competition from independent producers. The recent FDA crackdown particularly targeted the compounded version of Wegovy offered by Hims and Hers, a telehealth company valued between $300 million and $375 million.
On February 5, 2025, Hims and Hers announced their compounded Wegovy pill at a promotional price of $49 for the first month, rising to $99 thereafter for a five-month plan. This pricing starkly contrasted with the branded Wegovy, which costs $1,350 monthly for uninsured patients.
However, on February 6, FDA Commissioner Martin Makary publicly criticized non-FDA-approved GLP-1 drugs, specifically naming Hims and Hers. The FDA’s announcement aimed to restrict access to ingredients essential for producing these medications, stating, “These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.” The agency also intends to combat misleading advertising practices surrounding these compounded products.
By February 7, Hims and Hers ceased offering their pill version of Wegovy, although the injectable form remains available for $199 per month as part of a six-month plan. A spokesperson for the company declined to provide further comments on the matter.
In light of the FDA’s recent actions, Novo Nordisk has adjusted its pricing strategy, now offering medications at $150 monthly for individuals without insurance support. The ongoing debate surrounding the accessibility and affordability of essential medications continues to evolve, as patients and independent pharmacies navigate the implications of regulatory decisions.
