The U.S. Food and Drug Administration (FDA) , announced its intention to restrict access to active pharmaceutical ingredients (APIs) used in non-FDA-approved compounded drugs, particularly those marketed for weight loss. This action targets companies like Hims & Hers and other compounding pharmacies offering these products as alternatives to established, FDA-approved medications.
The FDA’s primary concern, as stated by Martin A. Makary, MD, MPH, the agency’s Commissioner, is ensuring patient safety. “These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy,” Dr. Makary explained in a press release. The agency is responding to the increasing availability of compounded GLP-1 receptor agonists – a class of drugs initially developed for type 2 diabetes, but increasingly used for weight management – that have not undergone the rigorous review process required for FDA approval.
Compounded drugs are created by pharmacies mixing ingredients to create a customized medication, often in response to a specific patient need that isn’t met by commercially available options. However, the FDA emphasizes that these drugs should only be used when an FDA-approved alternative is unavailable or unsuitable. The current situation, according to the FDA, involves mass marketing of compounded GLP-1s as readily available substitutes for approved medications, raising significant safety concerns.
The FDA’s concerns extend beyond the drugs themselves to the marketing practices employed by some companies. The agency is also cracking down on misleading direct-to-consumer advertising. Companies are prohibited from claiming that their compounded products are “generic versions” or “the same as” FDA-approved drugs. They cannot state that compounded drugs utilize the identical active ingredient or have undergone clinical trials demonstrating comparable results. These restrictions aim to prevent consumers from being misled about the quality and effectiveness of these products.
The FDA’s announcement comes after warning letters were sent to companies in the fall of regarding these marketing practices. The agency is prepared to utilize all available enforcement tools, including potential legal action such as seizure and injunctions, against entities that fail to comply with these regulations. The Department of Justice has also been alerted, with Hims & Hers specifically referred for investigation into potential violations of federal law.
The rise in popularity of compounded GLP-1s has been fueled by the high cost and, at times, limited availability of FDA-approved weight loss medications like Wegovy and Ozempic. Hims & Hers, for example, recently announced a $49 monthly price for a compounded version of a Wegovy alternative, significantly undercutting the brand-name drug’s price. Novo Nordisk, the manufacturer of Wegovy, has indicated its intention to pursue legal action against Hims & Hers in response to this move.
The FDA’s actions are not simply about restricting access to weight loss medications; they are rooted in fundamental concerns about drug safety and quality. Compounded drugs are not subject to the same stringent manufacturing standards and quality control measures as FDA-approved drugs. This can lead to inconsistencies in dosage, contamination, and other issues that could pose risks to patients. The FDA has specifically noted concerns about improper storage during shipping, with reports of injectable GLP-1 drugs arriving warm or without adequate refrigeration, potentially compromising their effectiveness.
The agency also highlights the issue of potentially non-existent compounding pharmacies being listed on product labels, raising further questions about the origin and quality of these drugs. The FDA recommends that patients obtain prescriptions from their doctors and fill them at state-licensed pharmacies to ensure they are receiving safe and effective medications.
For patients considering compounded GLP-1s for weight loss, the FDA advises a cautious approach. Compounded drugs may be appropriate only when a patient’s medical needs cannot be met by an FDA-approved drug, or if the approved drug is unavailable. Patients should discuss the risks and benefits with their healthcare provider and be aware that these products have not undergone the same level of scrutiny as their FDA-approved counterparts.
The FDA’s move is expected to have a significant impact on the market for compounded weight loss drugs, potentially limiting access to lower-cost alternatives. However, the agency maintains that its priority is protecting public health and ensuring that patients have access to safe and effective medications. The FDA will continue to work with state regulatory partners and communicate with compounders to address ongoing concerns and enforce compliance with federal regulations.
