The following is a statement from Steven J. Fleischman, MD, MBA, FACOG, president of the American College of Obstetricians & Gynecologists:

"ACOG commends the HHS leadership for improving the lives of perimenopausal women by making the estrogen products they need more accessible to them. The modifications to certain warning labels for estrogen products are years in the making, reflecting the dedicated advocacy of physicians and patients across the country. The updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms. ACOG has long advised clinicians to counsel patients based on an individual's unique risk factors and treatment goals; this announcement does not change ACOG's guidance on estrogen therapy.

"ACOG has long advocated for removal of the 'black box warning' on low-dose vaginal estrogen because the warning has posed a barrier for people who suffer from vaginal and urinary symptoms of menopause and could find needed relief with vaginal estrogen. By discouraging clinicians from prescribing low-dose vaginal estrogen, the current warning label harms patients by making inaccessible an effective treatment for symptoms that can significantly decrease health-related quality of life. We hope that this regulatory step forward will improve access to this important treatment option.

"As doctors who are dedicated to providing care throughout our patients' lives, including during menopause, we know that systemic estrogen therapy can be an important treatment option for people experiencing certain symptoms of menopause. While we support that this change will put shared decision-making back in the hands of patients and their trusted clinicians, it is important to distinguish that systemic estrogen products-such as oral estrogen and transdermal patches, gels, and sprays-have a different safety profile than low-dose vaginal estrogen. Like all medications, systemic estrogen products are not without risk, and their use should be based on an individualized conversation between patients and their clinicians. ACOG also continues to recommend against the use of compounded estrogen products, which are not backed by the FDA for their safety or efficacy, and are not subject to the HHS announcement."