US Lawmakers Petition FDA on Estradiol Patch Shortage
A group of Democratic members of the U.S. House of Representatives has urged the U.S. Food and Drug Administration to add estradiol patches to the agency's federal drug shortage database, as US prescriptions for the patches climbed from about 594,000 in June 2024 to 1.6 million in May 2026.
The US petition and its cross-border relevance
Dr. Suzanne Hackenmiller, an obstetrician-gynecologist in Arizona, has started a petition urging the FDA to formally declare a shortage of estradiol patches, arguing that a formal designation could give manufacturers an incentive to increase production. The American Society of Health-System Pharmacists lists more than a dozen estradiol patch products on its active drug shortage list.
The demand surge in the United States followed the FDA's removal of a 26-year-old "black box warning" from many hormone replacement therapy products in February. In its September update, the FDA said that although availability for certain products or brands varies by pharmacy or location, estradiol transdermal patches remain available, and the agency continuously monitors supply.
The Canadian angle is direct: CBS News reported that Los Angeles patient Diane Harris said she was even considering looking for the medication at pharmacies in Canada. Cross-border demand pressure on Canadian estradiol patch supply is a factor Canadian purchasers of estradiol patch pricing should be aware of.
Canadian regulatory context
In Canada, drug shortages are tracked through the drug shortage reporting website, and for certain drugs, manufacturers are required by law to report anticipated and actual drug shortages and discontinuations. Health Canada's Health Product Shortages Directorate can assemble a Tier Assignment Committee to determine whether a shortage qualifies as Tier 3, the most serious level.
Options available to Health Canada to help mitigate the impacts of a shortage may include using regulatory powers to allow drugs labelled and approved for other markets to be imported into Canada, and fast-tracking regulatory reviews. Health Canada may also extend the shelf life of a drug if there is suitable supporting data.
According to CBC reporting, the Drug Shortages Canada database shows that since 2017, there have been 92 shortages and four discontinuations of products containing estradiol, including transdermal patches, pills, vaginal rings, topical gels and creams.
Supply chain background
Christian Ouellet, vice-president of corporate affairs at Sandoz Canada, told CBC that producing a drug can take anywhere from 18 to 24 months, from sourcing raw materials to production to quality control to distribution. Mina Tadrous, a pharmacist and associate professor at the University of Toronto, said drugs often pass through multiple countries and several different facilities before reaching Canadian pharmacies.
For hormone products specifically, about 94% of active pharmaceutical ingredients that eventually become medications in the United States come from China or India. The starting raw ingredient for semi-synthesis of hormones in menopause hormone therapy is stigmasterol, sourced from soybeans.
What Canadian purchasers should note
A formal shortage designation in the United States could also affect what patients pay for their medication; CBS reported that some patients who normally receive a 90-day supply and pay one insurance copay have been forced to obtain 30-day supplies because pharmacies cannot provide the full prescription, resulting in patients paying the same copay multiple times.
For Canadian purchasers comparing options across formats, see current listings for estradiol gel pricing, oral estradiol pricing, and progesterone pricing. Additional coverage is available on our women's health news page.
This article is for informational purposes only and does not constitute medical advice.
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