The news: An FDA panel endorsed the removal of black box warnings on hormone therapies used for menopause. For context: Black box warnings are the strongest safety warning issued by the FDA for Rx drugs and highlight serious or life-threatening risks.

The 12 physician panelists were chosen by Dr. Marty Makary, the FDA commissioner, who is an outspoken supporter of the therapies and believes the benefits outweigh the risks. Several of the members had financial incentives tied to consulting for pharma companies or prescribing the therapies themselves, per the New York Times.

What led to it: Hormone replacement therapies were standard treatments for menopause before a landmark study in 2002 showed estrogen plus progestin therapy increased risks for heart disease, stroke and breast cancer.

• The FDA then added black box warnings about these risks in 2003. Doctors could still prescribe the treatments, but Makary claims more than 50 million menopausal women have not been offered hormone therapies, per the Times.
• 26.9% of postmenopausal women were taking hormone therapies in 1999, but only 4.7% did in 2020, per a JAMA study published in November.

Why it matters: Black box warnings are serious and can limit overt marketing of products.

Pfizer and Bayer are both hormone therapy manufacturers and focus more on marketing menopause awareness and advocacy for women struggling with symptoms.

• Pfizer’s podcast “Menopause: Unmuted” features personal stories and medical advice for menopause and its PfizerForAll telehealth platform includes a dedicated channel for menopause.
• Bayer US created a YouTube series “Redefining Menopause" earlier this year and teamed with United Nations Population Fund (UNFPA) to raise awareness and consideration in the workplace for women going through menopause.

Our take: Removing the black box warning could encourage pharma brands to not only develop more treatments but also market hormone therapy more. While personal risks and benefits still need to be weighed with a doctor, the change may result in more women on treatment.

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