FDA has made significant contributions to the field of women's health.
Throughout its history, the U.S. Food and Drug Administration (FDA) has worked to protect and promote the health of women. From identifying adulterated or unsafe products to approving new diagnostic technology, FDA strives to ensure that women in the U.S. have access to healthy foods and safe and effective medical products.
FDA strengthened its commitment to women in 1994 with the establishment of the Office of Women's Health (OWH). In the past 20+ years, OWH has worked across the Agency to advance the understanding and treatment of women's health issues and expand women's access to FDA's health and safety information.
Since 1994, FDA has increased its focus on approving medical treatments and diagnostic tools that help to improve the healthcare of women. FDA also changed regulations and provided guidance to industry on the evaluation of how medical products affect women. In addition, FDA has supported regulatory research that helps to identify and understand the mechanism of action for sex differences in the safety and effectiveness of FDA-regulated products as well as introduced new approaches for engaging and educating consumers and health professionals.
FDA's work has made a difference in improving the health of women. This page highlights some of FDA's significant accomplishments in women's health since 1994.
1993 – Issued “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” which revises the section of the 1977 guideline entitled “General Considerations for the Clinical Evaluation of Drugs” that excluded women of childbearing potential from participation in early studies of drugs.
1994 – Established the Office of Women’s Health (OWH) to protect and advance the health of women through policy, science, and outreach, and to advocate for the participation of women in clinical trials.
1994 – Implemented Mammography Quality Standards Act (MQSA) Program to ensure U.S. mammography facilities meet national standards for equipment, personnel, and quality control.
1994 – Approved the first diagnostic test to detect Her2/Neu gene as an indicator of breast cancer recurrence.
1994 – Approved the first drug treatment for the prevention of HIV transmission from infected pregnant women to their fetuses.
1994-1995 – Issued first consumer safety advisory about the risks to pregnant women and women of child bearing potential caused by consuming certain fish species containing high levels of methyl mercury.
1995 – Approved first of a new class of drugs, bisphosphonates, for the treatment of postmenopausal osteoporosis.
1995 – Established the OWH research program to support regulatory decision-making by providing a greater understanding of the impact of sex differences on medical product safety and efficacy.
1996 – Approved a liquid-based cytology preparation instrument for use in Pap smears that revolutionizes detection of cervical cancer.
1998 – Launched the Take Time to Care Program to disseminate FDA health and safety information to women and their families. Take Time to Care has since reached over 50 million women throughout the U.S. and Puerto Rico.
1998 – OWH-funded research helped FDA identify potentially life-threatening drug-induced cardiac arrhythmias to which women are especially prone. A popular antihistamine that caused this arrhythmia was later withdrawn from the market.
1998 – Approved the first computer software that assists radiologists in detecting mammogram abnormalities.
1998 – Required the addition of folic acid to certain grain products as an essential nutrient to help prevent birth defects of the brain and spine in the developing fetus.
2000 – Approved the first non-surgical drug to end an early pregnancy.
2000 – Approved digital mammography systems to detect subtle differences in breast tissue for the screening and diagnosis of breast cancer.
2001 – Approved the first transdermal (skin) patch and first hormonal vaginal ring for birth control.
2003 – Approved first of a new class of drugs to treat moderate to severe Alzheimer’s disease.
2003 – Added a boxed warning to labeling of estrogen and estrogen-plus-progestin products to treat menopausal symptoms. Warning alerts women to increased risk for heart attack, stroke, invasive breast cancer, and blood clots.
2004 - 2005 – Created a partnership between OWH, other government agencies and women’s organizations to educate 15 million women about benefits and risks associated with use of hormone therapy for menopause.
2005 – Launched Food Safety for Moms-to-Be outreach initiative to provide information to pregnant women and health educators.
2005 – Issued Guidance for Industry to assess the potential of a drug to affect heart cycle (QT interval prolongation) as women are more likely than men to have certain heart rhythm problems.
2006 – Approved the first vaccine for prevention of cervical, vulvar, and vaginal cancers and genital warts caused by certain strains of HPV in females 9-26 years of age.
2009 – Developed a method to analyze lead levels in lipstick.
2010 – Approved a smaller left ventricular assist device for heart failure, acknowledging sex differences in body size.
2011 – Revoked approval of the breast cancer indication for Avastin (bevacisumab) after FDA concluded that the drug had not been shown to be safe and effective for that use.
2011 – Approved the first 3D mammography imaging system (digital breast tomosynthesis) for use with 2D mammography.
2011 – Co-sponsored the Dialogues on Diversifying Clinical Trials conference to promote best practices for the inclusion of women and minorities in clinical research.
2013 – Co-sponsored the FDA CDRH Health of Women conference to discuss recruitment & retention, analysis and communication, and research roadmap for medical devices.
2013 – Approved first non-hormonal treatment for moderate to severe hot flashes.
2013 - Required manufacturers of zolpidem products to lower the recommended dose for women. Higher drug doses can impair morning activities demanding alertness, such as driving.
2013 - 2014 – Released the FDASIA Section 907 Report and Action Plan on the collection, analysis, and availability of demographic subgroup data for FDA-approved medical products.
2014 – FDA issued guidance on Evaluation of Sex-Specific Data in Medical Device Clinical Studies.
2014 – Approved the first human papillomavirus test for primary cervical cancer screening.
2014 – Approved the first medication for treatment of Non-24-Hour Sleep-Wake Disorder, a chronic disruption of the sleep-wake cycle affecting most individuals with total blindness.
2015 – Approved the first treatment for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
2015 – Approved the first targeted treatment for advanced breast cancer specifically for use in postmenopausal women.
2016 – FDA permitted marketing of the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.
2016 – FDA allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities.
2016 – OWH released the Women’s Health Research Roadmap to provide a strategic plan to address seven priority areas where new or enhanced research is important to FDA regulatory decision making on products impacting women’s health.
2016 – OWH in collaboration with the NIH Office on Research in Women’s Health launched the Diverse Women in Clinical Trial Initiative to raise awareness about the importance of participation of diverse groups of women in clinical research, and to share best practices about clinical research design, recruitment, and subpopulation analyses. www.fda.gov/womeninclinicaltrials.