Another Online Pharmacy Bypasses the FDA to Offer Cut-Rate Weight Loss Drugs

Hims & Hers Health, an online pharmacy initially known for prescribing erectile dysfunction medications, is now expanding its portfolio by offering knockoff versions of GLP-1 weight loss drugs. These drugs mimic the effects of Ozempic and Wegovy, whose active ingredient is semaglutide. The move aims to provide a more affordable alternative to the costly branded medications.

Compounded Alternatives: Cheaper but Unregulated

The versions offered by Hims & Hers are produced by compounding pharmacies. These pharmacies create medications by combining or altering ingredients to tailor drugs to specific needs. However, these formulations are not identical to the FDA-approved versions and have not undergone direct evaluation by the FDA. Despite this, the compounded versions are significantly cheaper, priced at $199 per month compared to over $1,000 per month for the branded versions without insurance.

Compounding pharmacies are legally allowed to produce knockoff versions of drugs when there is a shortage, which is currently the case with GLP-1 drugs. These medications are in high demand for their efficacy in treating diabetes and facilitating weight loss. Nevertheless, the FDA has already received reports of adverse events linked to compounded versions of semaglutide, raising concerns about their safety and effectiveness.

Hims & Hers’ Approach to Safety and Effectiveness

Hims & Hers claims to have conducted extensive research over the past year to ensure the safety and effectiveness of their compounded GLP-1 products. However, the company has not disclosed the name of the compounding pharmacy it partnered with. In a statement, Hims & Hers emphasized their commitment to providing safe and effective treatments:

Hims & Hers launched its weight loss program in December 2023, aiming to make a significant impact on the market. The program, costing $79 per month, is projected to generate over $100 million in 2025. The company’s business model relies heavily on subscriptions, with more than 90 percent of its revenue being recurring. Given that GLP-1 weight loss drugs need to be taken continuously to maintain weight loss, this could lead to a steady and growing subscriber base.

Rapid Growth and Aggressive Marketing

In the first quarter of 2024, Hims & Hers added a record 172,000 net new subscribers, as noted in their shareholder letter. This growth is partly driven by substantial investments in advertising, with campaigns aired during NBA and NFL games, as well as popular TV shows like "Keeping Up With the Kardashians" and "The Bachelorette."

Ro, another online pharmacy with a similar origin story, is also prescribing compounded versions of GLP-1 drugs. Ro has been known for its aggressive marketing strategies, including advertising weight loss drugs on the New York City subway system.

The Bigger Picture

While Hims & Hers and Ro are making these treatments more accessible and affordable, the lack of FDA oversight on compounded medications raises significant safety concerns. The effectiveness and safety of these knockoff versions remain questionable, especially in light of adverse event reports.

As the demand for weight loss solutions continues to rise, it is crucial for consumers to be aware of the potential risks associated with non-FDA-approved medications. Companies like Hims & Hers must prioritize transparency and rigorous quality control to ensure that they are providing safe and effective treatments to their customers.

Stay tuned for more updates as we continue to monitor the developments in this rapidly evolving market.