Novo Nordisk Ends Collaboration with Hims & Hers Over Wegovy Compounding Concerns

Novo Nordisk $NVO has formally terminated its partnership with Hims & Hers Health Inc. $HIMS, citing violations related to the compounding and promotion of non-FDA-approved versions of Wegovy, its prescription obesity drug. The Danish pharmaceutical company said the telehealth provider engaged in unauthorized sales under the guise of personalized medicine.

Pre-Market Reaction and Strategic Implications

The decision caused HIMS shares to fall nearly 20% in Monday’s premarket session. The move comes just months after Novo Nordisk allowed a limited number of telemedicine platforms to distribute Wegovy, following the resolution of earlier supply constraints in the U.S. market. Now that shortages are officially over, pharmacies and third parties are no longer permitted to produce or sell compounded versions, except in narrowly defined clinical circumstances.

Alleged Legal Breaches

Novo Nordisk claims Hims & Hers:

1. Distributed compounded semaglutide formulations beyond permissible limits;

2. Marketed these products as customized treatments without valid justification;

3. Failed to comply with compounding restrictions under Section 503A of the U.S. FDCA;

4. The company characterized the actions as misleading and potentially dangerous to patient health.

Regulatory Framework

Under FDA rules, large-scale compounding of commercially available drugs is prohibited unless specific shortage declarations are in place. Wegovy no longer qualifies under these exemptions. Novo Nordisk’s move underscores growing pressure on digital health providers to align with drug safety regulations, especially amid heightened demand for GLP-1-based therapies.

Telehealth Business at Risk

Hims & Hers positioned itself as a low-cost distributor of weight-loss drugs, using compounded versions to meet consumer demand. The loss of its Novo Nordisk partnership raises operational and compliance risks, potentially affecting revenue and strategic positioning in the expanding obesity treatment market. This event signals increased regulatory scrutiny for online health platforms distributing prescription medications. The conflict illustrates the tension between rapid telehealth growth and pharmaceutical governance.