Women's Health E-Update July 2023

Message from the Associate Commissioner

Dear Women’s Health Colleagues,

As I shared with you last week, FDA recently approved the Opill (norgestrel) tablet for nonprescription use to prevent pregnancy—the first daily oral contraceptive approved for use in the U.S. without a prescription.

Almost half of the 6.1 million pregnancies in the U.S. each year are unintended. Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes. Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.

In other women’s health news, we recognize Fibroid Awareness Month in July. Uterine fibroids are the most common benign (not cancerous) tumors, or growths, that occur in women of childbearing age. Fibroids grow in and around the muscular wall of the uterus and are more common in African American than in White, Hispanic, or Asian women.

Fibroids do not always cause symptoms, but some women may experience abdominal pain, heavy bleeding, frequent urination, pregnancy complications, reproductive problems, and other symptoms. Treatments for moderate or severe symptoms may include medication or surgery. Talk with your health care provider about which options may be best for you.

Learn more by viewing our uterine fibroid video, or print and share our fibroid fact sheet—one of the many women’s health resources OWH provides.

Sincerely,

Kaveeta P. Vasisht, M.D., Pharm.D.

Your mental health is just as important as your physical health. Did you know that more than 1 in 5 women in the United States experienced a mental health condition in the past year, such as depression or anxiety? Mental illness can affect women of all races and ethnicities. Having access to and awareness of mental health care services is essential to effectively managing your mental health.

This National Minority Mental Health Awareness Month, take action to raise awareness of and advance mental health equity. Start by reading our latest blog post to learn more about mental illnesses common to women, and tips for managing your mental health. Other resources to share with your family and community include the FDA OWH Women and Anxiety fact sheet, Women and Depression information, and Depression Medicines Guide.

• FDA Approves New Drug to Prevent RSV in Babies and Toddlers
• FDA Approves First Nonprescription Daily Oral Contraceptive
• What We’re Doing to Stop Illicit Xylazine from Getting into the U.S.
• FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval
• How to Report Problems with E-Cigarettes, Cigarettes, Cigars, or Other Tobacco Products to the FDA
• Dermal Fillers (Soft Tissue Fillers)
• FDA, FTC Warn Six Companies for Illegally Selling Copycat Food Products Containing Delta-8 THC
• FDA Approves First Gene Therapy for Adults with Severe Hemophilia A
• FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
• FDA Provides Update on Proposal for Unified Human Foods Program, including New Model for the Office of Regulatory Affairs
• FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
• FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy 
• How to Properly Store E-Liquids and Prevent Accidental Exposure of E-Liquids to Children
• FDA Inspection Blitz Leads to More Than 180 Warning Letters to Retailers for the Illegal Sale of Youth-Appealing Elf Bar and Esco Bars E-Cigarettes
• FDA Launches Pilot Program to Help Reduce Risks Associated with Using Laboratory Developed Tests to Identify Cancer Biomarkers

Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy.  Learn more about pregnancy registries today!

• July 25 - Conversations on Cancer – Cancer Disparities in Appalachia
• August 22-23 - Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
• September 6 - Patient Engagement Advisory Committee Meeting Announcement

Visit FDA Meetings, Conferences and Workshops to find out about available meetings.