Hims & Hers, a telehealth company, is under scrutiny for marketing compounded semaglutide medications that are not approved by the Food and Drug Administration (FDA). This controversy gained traction following the company's recent Super Bowl advertisement, which highlighted these weight loss medications without clarifying their FDA status. The compounded semaglutide is manufactured from FDA-regulated bulk outsourcing facilities, but the medications themselves are not formally approved by the FDA.
Compounded medications differ from brand-name or generic drugs in their regulatory oversight. While the FDA approves brand-name and generic drugs, compounded medications do not undergo the same approval process. This distinction is crucial because FDA-approved medications must list possible side effects and contraindications, ensuring patients are aware of potential risks. However, Hims & Hers' advertisement omitted this practice, sparking concern among health professionals and lawmakers.
The doctrine of fair balance, a requirement for FDA-approved product advertisements, mandates that information about risks and side effects be presented alongside benefits. Hims & Hers is not subject to this regulation for their compounded semaglutide, raising questions about consumer safety. The compounded versions of GLP-1 agonists or semaglutides offered by Hims & Hers aim to manage Type 2 diabetes and obesity. Although the brand-name versions are FDA-approved, their compounded counterparts lack such approval.
The FDA has received reports of hospitalization due to accidental dosing errors with compounded weight-loss drugs. These incidents underscore the potential risks associated with compounded medications. Senators Richard Durbin of Illinois and Roger Marshall of Kansas have expressed concerns about what they perceive as a regulatory loophole that allows marketers to bypass fair balance requirements.
"To the extent this falls within a regulatory loophole for the FDA's authorities, we plan to soon introduce bipartisan legislation to close this gap," – Senators Richard Durbin (D-IL) and Roger Marshall (R-KS).
Compounded medications can be made in small batches at neighborhood pharmacies or in bulk at outsourcing facilities. The latter, which supply Hims & Hers, are inspected by the FDA to ensure safety standards are met. Additionally, manufacturers must procure their ingredients from FDA-approved suppliers. Despite these precautions, the lack of FDA approval for the final product remains a significant issue.
Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines, voiced concerns about the mass marketing and production of compound medications. He argues that these practices may compromise drug safety.
"By mass marketing and mass producing compound medications, we are devolving the safety of our drug supply," – Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines.
Safdar emphasized the need for public education on this topic, highlighting a gap in awareness among consumers about the nature of compounded medications.
"We're not having a debate about it, and we're not even educating Americans about it." – Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines.
Despite the concerns, Safdar acknowledges the importance of compounding in medicine.
"We need compounding," – Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines.
The FDA has issued an alert regarding the potential risks associated with compounded versions of GLP-1s. This alert serves as a cautionary note for patients and healthcare providers considering these alternatives to FDA-approved medications.
