FDA Resolves Semaglutide Shortage, Impacts Hims & Hers Shares and Compounded Medications

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The U.S. Food and Drug Administration (FDA) has announced that the shortage of semaglutide injection products has been resolved, leading to a significant impact on Hims & Hers Health, a digital health company that has been prescribing compounded semaglutide as an alternative to brand-name medications. Shares of Hims & Hers closed down around 26% on Friday after the FDA's announcement, which stated that the current supply of semaglutide can meet present and future demand. Semaglutide is the active ingredient in Novo Nordisk's blockbuster weight loss drug Wegovy and diabetes treatment Ozempic, and demand for these treatments has exploded in recent years.

Hims & Hers has been offering compounded semaglutide to patients since May, and the company owns compounding pharmacies that produce the medications. Compounded drugs are custom-made alternatives to brand-name drugs designed to meet a specific patient's needs, and compounders are allowed to produce them when brand-name treatments are in shortage. However, the FDA does not review the safety and efficacy of compounded products, which has raised concerns about the potential risks associated with these medications. The FDA has issued multiple warnings about using off-brand semaglutide, including counterfeit forms of the drug that have been circulating through the U.S. drug supply chain.

The resolution of the semaglutide shortage means that compounders will no longer be allowed to produce the medication, and Hims & Hers will have to adjust its business strategy. The company has announced that it will continue to offer access to personalized treatments as allowed by law to meet patient needs, and it is closely monitoring potential future shortages. Hims & Hers has also acquired a U.S.-based peptide facility that will further verticalize the company's long-term ability to deliver personalized medications, and it has bought Trybe Labs, a New Jersey-based at-home lab testing facility. These moves are expected to help the company expand its weight loss program, which has been a massive hit with investors, with shares of the company climbing more than 200% last year and already up more than 100% this year despite Friday's move.

The FDA's decision to resolve the semaglutide shortage has also raised concerns about the potential impact on patients who have been relying on compounded medications. The agency has announced that it will allow companies to continue dispensing compounded semaglutide for up to 90 more days, but after that, patients will have to switch to brand-name medications or find alternative treatments. This has sparked concerns about the potential disruption to patient treatment, particularly for those who have been relying on compounded semaglutide for their weight loss or diabetes treatment. The FDA has stated that it will continue to monitor the situation and take steps to ensure that patients have access to safe and effective treatments.

In terms of the regulatory landscape, the FDA's decision to resolve the semaglutide shortage has significant implications for the pharmaceutical industry. The agency has stated that it will start taking action against compounders for violations in the next 60 to 90 days, depending on the type of facility, in order to "avoid unnecessary disruption to patient treatment." This has raised concerns about the potential impact on the pharmaceutical industry, particularly for companies that have been relying on compounded medications. The FDA's decision has also highlighted the need for increased oversight and regulation of the pharmaceutical industry, particularly with regards to compounded medications. Some of the key points to consider include: * The FDA's decision to resolve the semaglutide shortage has significant implications for the pharmaceutical industry * The agency will start taking action against compounders for violations in the next 60 to 90 days * Patients who have been relying on compounded semaglutide will have to switch to brand-name medications or find alternative treatments * The FDA will continue to monitor the situation and take steps to ensure that patients have access to safe and effective treatments * The pharmaceutical industry will need to adapt to the new regulatory landscape and find ways to ensure that patients have access to safe and effective treatments.