Another online pharmacy bypasses the FDA to offer cut-rate weight loss drugs
Cut-Rate Diet Drugs: Safe or Risky Gamble?
Hims & Hers Health is now selling cheaper, non-FDA-approved versions of weight loss drugs similar to Ozempic and Wegovy, priced at $199 a month. These versions are made by compounding pharmacies and have not been evaluated by the FDA, raising safety and effectiveness concerns. The company, which primarily earns through subscriptions, launched its weight loss program in December 2023 and aims to generate significant revenue by 2025.
What are the reasons compounding pharmacies are allowed to make knockoff versions of branded drugs like GLP-1?
Compounding pharmacies are allowed to make knockoff versions of branded drugs like GLP-1 in certain situations due to shortages of the FDA-approved medications2. The US Food and Drug Administration (FDA) allows compounding pharmacies to prepare "essentially a copy" of the approved drug when a drug is listed on the shortage list. This is because compounded drugs can help meet the needs of patients who cannot access the FDA-approved medications due to shortages23.
Compounding pharmacies can also tailor a custom-made medication to meet a patient's specific needs, such as when an FDA-approved medication, dose, or dosage form is unavailable or if a patient has an allergy or other reasons that require a different form of the medication3. However, it's important to note that compounded drugs are not FDA-approved and do not undergo the same rigorous testing and approval process as the branded versions.
While this allows compounding pharmacies to step in and provide medications during shortages, there are risks associated with using compounded drugs, as they may not be subject to the same safety, quality, and effectiveness assurances as FDA-approved drugs2. The FDA has received reports of adverse events related to compounded versions of semaglutide, one of the active ingredients in GLP-1 drugs.
In summary, compounding pharmacies are allowed to make knockoff versions of branded drugs like GLP-1 to address shortages and meet specific patient needs, but patients should be aware of the potential risks and differences between compounded and FDA-approved medications2.
How does Hims & Hers plan to grow its subscriber base, according to the company?
Hims & Hers plans to grow its subscriber base by expanding its offerings and services, as well as investing in marketing and advertising efforts. The company has introduced new services such as primary care and mental health, and has also launched new products like weight loss programs. Additionally, Hims & Hers has increased its advertising efforts, with a focus on TV advertising during popular events like NBA and NFL games, as well as shows like Keeping Up with the Kardashians and The Bachelorette. By continuously adding new services and products, and by targeting a wide range of customers through advertising, Hims & Hers aims to attract more subscribers and grow its customer base.