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Surge in hormone therapy demand prompts calls for FDA to declare estrogen patch shortage

Patients, physicians, and lawmakers are urging federal regulators to officially list estradiol patches as in shortage following a sharp increase in prescriptions.

The short version

  • Doctors, patients, and Democratic lawmakers are pressing the FDA to officially recognize a nationwide shortage of estradiol patches.
  • Prescriptions jumped after the FDA removed a longstanding black box warning on hormone replacement therapy in February.
  • While the American Society of Health-System Pharmacists lists multiple patch products in shortage, the FDA maintains that the medication remains available despite localized disruptions.
  • Advocates argue an official shortage declaration is needed to spur manufacturing capacity and ease supply constraints.

Key facts

  • Prescriptions for estrogen patches rose from approximately 594,000 in June 2024 to 1.6 million in May 2026, according to HealthVerity data.[CBS News]
  • The demand spike followed the FDA's February decision to lift a 26-year-old black box warning from several hormone replacement therapy medications.[CBS News]
  • The American Society of Health-System Pharmacists includes more than a dozen estradiol patch products on its active drug shortage list.[CBS News]
  • A group of House Democrats sent a letter urging the FDA to list estradiol patches on the federal shortage database, arguing the agency's reliance on historical data is causing a reporting lag.[CBS News]
  • The FDA acknowledged reports of regional access difficulties but stated that estradiol transdermal patches remain available and that it is collaborating with manufacturers to expand supply.[CBS News]

What remains uncertain

  • It is uncertain whether the FDA will formally designate estradiol patches as in shortage or when manufacturing capacity will catch up with heightened consumer demand.[CBS News]

Sources