Key facts
- Shortages of hormone replacement therapies in the US have expanded beyond estrogen patches to include injectable and vaginal estrogen products.
- Demand for hormone replacement therapy has increased following the FDA's removal of a boxed warning on some hormone therapies.
- Supply-chain issues and a domino effect from patch shortages are impacting alternative estrogen products.
- Manufacturers are struggling to meet demand, with some expanding production capacity.
- Viatris has added a production shift at its Vermont facility and is investing in new production lines.
Women in the US are facing a widening supply crunch for hormone replacement therapies, with shortages now affecting injectable and vaginal estrogen products in addition to the already scarce estrogen patches. The US Food and Drug Administration has been working with manufacturers since September to increase the availability of estrogen patches, but demand continues to outstrip supply. The increased demand for hormone replacement therapy has been attributed, in part, to the FDA's removal last year of a long-standing boxed warning on some hormone therapies that had previously signalled potential health risks.
Pharmacies and drug-shortage monitors report that alternative forms of estrogen are also becoming difficult to find. Kevin Schipper, director of product lifecycle management at ProPharma, suggested that women are switching from the hard-to-find patches to other products, creating a domino effect that impacts the supply of gels, creams, and injections. CVS Health noted that manufacturers have faced difficulties in supplying certain strengths of estradiol injections, a situation that has worsened recently. Telehealth provider Midi Health also described growing supply-chain issues impacting alternative treatments.
Cost Plus Drugs, an online pharmacy founded by Mark Cuban, has seen demand for estrogen replacement products surge fivefold to tenfold, but has managed to maintain supplies with only intermittent interruptions. The FDA stated in September that the supply of approved estradiol patches had nearly doubled in the past year but still lagged behind demand. Viatris, a key manufacturer, reported a significant surge in demand and has increased production at its Vermont facility, while also investing in expanding long-term capacity. Other manufacturers like Amneal are also working to increase production in response to heightened demand.