FDA drops boxed warnings on menopause hormones
The FDA removed the long-standing boxed warning from hormone-based menopause drugs, saying updated evidence shows benefits for women. Officials — including HHS Secretary Robert F. Kennedy Jr., who called the move “challenging outdated thinking” — said the change was made without convening a formal advisory committee to avoid a “bureaucratic” and costly process, and Makary explained why an advisory panel was not used.
📌 Key Facts
- The FDA removed boxed warnings from menopause hormone therapy labeling.
- FOX 9 Minneapolis-St. Paul reported the labeling change on 2025-11-11 in an article titled 'Menopause hormone therapy labeling changed under FDA'.
- The FDA did not convene a formal advisory committee for the decision; officials characterized avoiding an advisory committee as a way to prevent a 'bureaucratic' and costly process.
- Makary was quoted explaining the rationale for not using an advisory panel.
- HHS Secretary Robert F. Kennedy Jr. said the move challenges 'outdated thinking' and emphasized it reflects evidence-based medicine.
📰 Sources (2)
Menopause hormone therapy labeling changed under FDA
New information:
- FDA did not convene a formal advisory committee for this decision, which officials characterized as avoiding a 'bureaucratic' and costly process.
- Quote from HHS Secretary Robert F. Kennedy Jr. framing the move as 'challenging outdated thinking' and emphasizing evidence-based medicine.
- Makary is quoted explaining why an advisory panel was not used in this instance.