Physician advocacy drives landmark FDA change for HRT

In this video, Sameena A. Rahman, MD, an obstetrics and gynecology physician with Northwestern University Feinberg School of Medicine in Chicago, Illinois, describes the FDA’s removal of broad boxed warnings on systemic hormone replacement as a landmark victory for women’s health, clinicians, and long-term medical advocacy.

She emphasizes that the change did not happen overnight but was the result of more than a decade of sustained effort by physicians and researchers. Beginning around 2016–2017, multiple professional societies—including menopause and obstetrics/gynecology organizations—worked together to challenge the boxed warning on vaginal estrogen, arguing that not all estrogens are the same and that the warning was not supported by evidence. For Rahman, the decision underscores the tangible power of physician advocacy when grounded in science, research, and collective action.

Rahman notes that many clinicians hesitate to engage in advocacy or policy work, often fearing politicization. However, she argues that this outcome demonstrates why physician voices matter, particularly for populations that are often unheard, including women and minority women. As clinicians, she says, physicians have both authority and responsibility to speak up on behalf of patients. She stresses that progress occurs when medical professionals step out of their silos, become vocal, and collaborate across disciplines and political lines. The FDA decision, she believes, is proof that bipartisan advocacy for women’s health can lead to meaningful systemic change.

Addressing the broader implications, Rahman said she sees this development as a hopeful signal amid a challenging landscape for women’s health care. She acknowledges the ongoing political and regulatory pressures affecting access to care, including restrictions that have led some OB-GYNs to leave certain states. Against this backdrop, the FDA’s action represents a “ray of sunshine” and a source of renewed optimism. It reassures clinicians that there are still decision-makers who prioritize patient-centered care. Rahman hopes this momentum will lead to greater recognition of gynecologic and urologic needs and inspire further reforms in women’s healthcare, reinforcing the idea that sustained advocacy can help the system evolve for the better.