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Message from the Associate Commissioner

Dear Women’s Health Colleagues, 

The FDA Office of Women’s Health (OWH) works to advance the health of women through scientific programs, policy development, research, education, and outreach.

As 2023 comes to an end, I would like to acknowledge and highlight some of the accomplishments this year of the dedicated OWH staff— an excellent team who help move women’s health forward every day.

I invite you to review some of the activities OWH implemented and supported throughout the year summarized below and shared in our December Knowledge and News on Women’s Health blog.

I hope you have a happy, healthy holiday season, and look forward to connecting with you in the new year, as OWH enters our 30th year of protecting and promoting women’s health in 2024.

Sincerely,

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

Associate Commissioner for Women’s Health
Director, Office of Women’s Health (OWH)

2023 Women's Health Year in Review

OWH scientific webinars, workshops, and meetings

Throughout the year, OWH hosted educational webinars for FDA and HHS employees, and public workshops and webinars for health care professionals and other stakeholders on the latest scientific research on a broad range of health topics important to women.

Public workshops and meetings included: PCOS Revisited: Diagnosis, Management, and Future Needs, Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research and Bringing Clinical Research to Patients. Learn more and view recordings of these and other OWH events.

OWH funding initiatives and research publications 

OWH awards research grants for studies to address regulatory research questions related to women's health issues and the impact of sex differences on product safety and efficacy.

During 2023, we funded a wide variety of projects as part of OWH’s women’s health research program, such as a study on human skin model to predict absorption of cosmetic ingredients, a project evaluating sex disparities in safety signals for opioid drugs, and a project with a systematic approach to predict the excretion of antidepressants into breast milk.

OWH research funded in previous years produced several peer-reviewed publications in 2023, on topics including heart failure, machine learning algorithms, medical device validation, and SARS-CoV-2 (the virus that causes COVID-19).

OWH staff also published peer-reviewed scientific articles on topics including medication use during pregnancy, the use of hormone replacement therapy (HRT) to treat menopausal symptoms, and the participation of HIV-1 infected treatment-naive females in clinical trials and sex differences in efficacy and safety outcomes.

Outreach and consumer education activities and resources

OWH’s theme for National Women’s Health Week (NWHW) 2023 was to encourage women to #KNOWHmore About Your Health, Today and Every Day. Some of the topics highlighted for the week included pregnancy, uterine fibroids, menopause, and polycystic ovary syndrome (PCOS).

In 2023, OWH produced a new video and blog to provide information on pregnancy exposure registries. Pregnancy exposure registries are research studies that collect information about the effects of prescription medicines taken, or vaccines received during pregnancy. We encourage you to learn more and review our updated pregnancy exposure registries webpages. 

A few years ago, OWH created the Knowledge and News on Women’s Health blog to educate and share the latest women’s health topics and insights that may not be well known to women and other stakeholders. Along with the pregnancy registries OWH blog, additional topics included women and heart health, PCOS, minority mental health, and mammography.

Our researchers do important and groundbreaking work in science, technology, engineering, and math (STEM) across the FDA. In honor of National STEM Day, members of OWH shared what it’s like to pursue a career in STEM and why we need more young women in this industry. Check out our video and the FDA STEM Day webpage to learn more.   

To raise awareness about the importance of mammograms for breast cancer screening, OWH developed new mammography resources including a new video, blog, and social media toolkit (PDF, 1.8 MB), and updated mammography webpage to help educate women about the importance mammograms as

In 2023, OWH distributed more than 1.6 million women’s health publications to inform, empower, and engage our various stakeholders. OWH created new women and anxiety web content and fact sheets in 19 languages to provide women with more information on anxiety symptoms, common treatment options, and more. OWH updated the heart health social media toolkit (PDF, 6.67 MB) to help women learn more about heart disease. Visit our heart health webpage to learn more.

We also updated our College Women’s Campaign (CWC) social media toolkit to help students and schools share our free women’s health resources on campuses and in communities. Review the updated CWC webpage, download the toolkit in English (PDF, 13.84 MB) and Spanish (PDF, 602 KB), and order the newly revised 5 Steps for Safe Medication Use for College Women (PDF, 6.7 MB) poster to display on college campuses at Free Publications from the U.S. Food and Drug Administration's (FDA's) Office of Women's Health (gpo.gov)

We encourage you to view and share these and other OWH women’s health topic resources and share this email with a friend or colleague.

It’s a good time to get your flu vaccine

Flu viruses typically spread in fall and winter, with activity peaking between December and February. Flu is a serious disease caused by influenza viruses that can lead to hospitalization and even death. Every flu season is different, and anyone can get sick with flu. Typically, children and people 65 and older are most at risk of developing serious complications from influenza. In addition, pregnant people and those with certain chronic medical conditions are also most at risk of complications. Your best defense against influenza disease is to get a flu vaccine every year. 

It is not too late to get vaccinated. The CDC recommends that people ages 6 months and older get a flu vaccine each year. Check with your health care provider and find flu vaccines in your area.

Women’s health news and updates

• FDA Provides Updates to Breast Implants Information
• FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
• FDA Approves Capivasertib with Fulvestrant for Breast Cancer
• CDC and FDA Expedite the Availability of Additional Doses of New RSV Immunization for Infants

More updates from around FDA

• Beware of Illegally Marketed Diabetes Treatments and Fraudulent Pharmacies
• Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches (December 2023)
• FDA Advances Reorganization Proposal for Unified Human Foods Program, Field Operations and Additional Modernization Efforts
• FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease
• FDA Issues Final Guidance on Developing Drugs for COVID-19 Treatment and Prevention
• FDA, USDA, and EPA Propose National Strategy to Reduce U.S. Food Loss and Waste
• FDA Voices: The Importance of Clinical Trial Transparency and FDA Oversight
• Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
• FDA Cautions Public of Safety Issue with Philips’ DreamStation 2 CPAP Machines
• Antiseizure Medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug Safety Communication - FDA Warns of Rare but Serious Drug Reaction
• FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act
• CDRH Takes Steps to Advance Further Discussions on Pulse Oximeters - Pulse Oximeter Accuracy: Two New FDA Initiatives

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!

• January 10, 2024 - FDA Oncology Center of Excellence, Conversations on Cancer, Bringing Innovation to People Facing Cancer (Discussion will highlight oncology drug approvals in 2023)
• January 16, 2024 - FY24 FDA Broad Agency Announcement Question and Answer Session
• January 23-24, 2024 - Advancing Drug Development for the Prevention of Spontaneous Preterm Birth – virtual public meeting
• January 31, 2024 - FDA announces joint public meeting with Duke-Margolis on Improving the Quality of Clinical Studies
• February 2, 2024 - Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting (Discussion on improving quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation and patient-reported race and ethnicity.)
• March 1, 2024 - Public meeting: FDA Rare Disease Day 2024
• March 19-20, 2024 - Public Workshop - Enhancing Adoption of Innovative Clinical Trial Approaches 

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