Reps. Dingell, Tlaib, & Scholten Praise FDA & RFK, Jr. For Removing Estrogen Black Box Warning

Not the usual reactions we have come to expect from Michigan's Democratic U.S. House members:

https://thehill.com/policy/healthcare/5691761-hormone-therapy-fda-house-democratic-women/

https://www.nationalacademies.org/read/25791/chapter/19#310

Democratic Women’s Caucus commends FDA for lifting black box warning on estrogen
By Joseph Choi - January 15, 2025

The House Democratic Women’s Caucus (DWC) commended the Food and Drug Administration (FDA) and Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. for lifting the black box warning on estrogen-based products for hormone replacement therapy (HRT).

In November, Kennedy announced that the FDA would be removing the black box warning from estrogen-based HRT products, saying at the time, “Millions of women were told to fear the very therapy that could have given them strength, peace and dignity through one of life’s most difficult transitions, menopause.”

Owing to federally funded studies from more than 20 years ago, a black box warning for cardiovascular disease, breast cancer and probable dementia was placed on estrogen-based HRT. At the time of the announcement, the Menopause Society said it agreed with the FDA’s decision.

In a letter first shared with The Hill, the DWC praised the move as a “commitment to science-based regulation and the health of women nationwide.”

“We urge HHS and the FDA to continue advancing rigorous research on hormone therapy’s safety and effectiveness, particularly as your agencies update product labeling and risk communication,” the DWC said in a letter to Kennedy and FDA Commissioner Marty Makary, marking a rare moment of Democratic support for President Trump’s health officials.

“We are currently in a moment that underscores the broader importance of women’s health research across the lifespan, including menopause. Sustained investment in women’s health science has been shown to improve quality of care when women’s health concerns are no longer treated as niche or secondary concerns,” the caucus added.

“Defunding or weakening women’s health research initiatives, particularly those focused on menopause, would reverse recent progress and perpetuate the pattern in which women’s symptoms are neglected.”

The DWC urged the FDA to support more studies on the safety of hormone therapy, increase resources for federal menopause research, implement targeted education on the guidelines, and maintain strong postmarket regulation of hormone products.

The lawmakers who signed the letter were Democratic Reps. Ayanna Pressley (Mass.), Kelly Morrison (Minn.), Judy Chu (Calif.), Lori Trahan (Mass.), Gwen Moore (Wis.), LaMonica McIver (N.J.), Shontel Brown (Ohio), Deborah Ross (N.C.), Debbie Dingell (Mich.), Yvette Clarke (N.Y.), Frederica Wilson (Fla.), Veronica Escobar (Texas), Adelita Grijalva (Ariz.), Rashida Tlaib (Mich.), Bonnie Watson Coleman (N.J.), Pramila Jayapal (Wash.), Laura Friedman (Calif.), Melanie Stansbury (N.M.), Sheila Cherfilus-McCormick (Fla.), Jill Tokuda (Hawaii), Debbie Wasserman Schultz (Fla.), Chrissy Houlahan (Pa.), Hillary Scholten (Mich.), Sylvia Garcia (Texas), Teresa Leger Fernández (N.M.), and Jan Schakowsky (Ill.).