Science & Research
Protecting and Advancing the Health of Women, a Congressional Briefing
FDA's Office of Women's Health (OWH) serves as a champion for women's health both within and outside the agency. It was created in 1994 and consists of science, data and outreach programs.
Since its beginning, OWH funded high quality scientific research to serve as the foundation for agency activities that improve women's health. To date, OWH has funded over 100 research projects and spent about $12 million. Much of the headway these programs achieved was made possible through a 1999 partnership with the National Centers of Excellence in Women's Health. In response to congressional mandates, recent studies have examined:
Gender Differences in Product Safety and Efficacy -- Not only do women experience more adverse reactions to medicines than men, these reactions often are more serious as well. OWH-sponsored research plays a pivotal role in drug development and labeling to minimize harmful gender-specific side effects. For example, women are particularly vulnerable to torsades de pointes, a potentially fatal abnormal heartbeat from which men are protected by male sex hormones. Because of OWH research, all new drug products are now screened to determine their potential to cause torsades de pointes.
Heart Disease in Women -- Heart disease is the number one killer of women. FDA OWH has funded a number of projects to understand heart disease in women.
- One study examined the data from clinical studies of a medicine that dissolves blood clots to determine why women hospitalized with heart attack died at almost twice the rate of men. It was found that more men died before hospitalization, biasing clinical studies.
- An FDA OWH funded study found that women are treated with Implantable Cardioconverters ( ICDs) less often than men despite a similar incidence of heart disease, and that older women (70-85 years) who are treated with ICDs live significantly longer than men of a similar age. Clearly, women with heart disease should be treated with ICDs when appropriate.
Breast Implants -- One OWH-funded study of silicone gel implants reported about 55% of recipients experienced ruptures, with about one-third of them requiring additional surgery. This information has been provided to FDA scientists and to the general public through our website and in publications.
Dioxin in Tampons -- OWH funded a study that showed that most tampons contain undetectable or very low levels of dioxin. The agency is confident that tampons are not an important source of dioxin exposure and women can use tampons without fear of adverse health effects from dioxin.
Designing New Data Systems
The Demographic Information and Data Repository Status Report (DIDR)-- is a Congressionally mandated program designed to enable the assessment of women of all ages, races, and ethnic groups. It is an integrated set of repositories, holding information for use in assessing participation in clinical trials and differences in risk and benefit for sub-populations using drugs, biologics and devices in clinical trials. The DIDR will improve the management of information needed for risk-based evaluations of safety and efficacy for products regulated by FDA, and facilitate gender analysis while providing informative data that may be used across all demographic sub-groups.
The DIDR program also sponsored the development of the standard for the first fully- electronic label, making drug-labeling read consistently across all computer systems. This standard will be used in the pilot for electronic prescribing mandated in the 2003 Medicare Modernization Act, helping to establish the National Health Information Infrastructure and improving patient drug safety in doctors offices, hospitals, pharmacies and at home.
Empowering Consumers With Reliable Information
The Take Time to Care (TTTC) outreach initiative not only recognized the multiple roles of American women as family caretakers, educators, nurturers and leaders, it provided the empowering information to make healthy choices for themselves, their families and their communities. It was awarded the prestigious Pinnacle Award, representing 97 national health and professional associations, and was the first federal agency to receive this distinction.
OWH created the "Use Medicines Wisely" campaign to educate women on proper medicine usage. OWH partnered with 60 national organizations and the National Association of Chain Drug Stores (NACDS), to bring the campaign to more than 20,000 rural and urban pharmacies across the country. More than six million "My Medicines" brochures were printed and distributed in 14 languages.
Diabetes currently affects more than 19 million Americans, more than half of them women. OWH partnered with NACDS and the American Diabetes Association to promote the following message: Diabetes can be controlled through watching your diet and exercise, checking your blood sugar, using medicines wisely and knowing your ABCs (A-1-C, blood pressure and cholesterol).
- The campaign received coverage in the Wall Street Journal, Parade magazine, the Chicago Tribune and the Hints from Heloise syndicated column.
- A disease-specific educational website-the first of its kind in FDA -was created to provide information links from agencies across the HHS.
- The campaign's brochure was translated into more than 10 Asian languages.
- Spanish-language networks Telemundo and Univision contributed more than $92,000 in free airtime.
In response to a congressional mandate, OWH collaborated with the National Institutes of Health and other federal agencies to launch the Menopause and Hormones Information Campaign in 2003. We worked closely with women's advocacy and health professional organizations to clear up some of the confusion women had voiced following the results of the Women's Health Initiative. To date:
- Over 1 million pieces of English- and Spanish-language campaign information have been distributed across the United States.
- Radio public relations efforts have generated 492 minutes of airtime, including interviews with FDA officials.
Take Time To Care About ... Breast Cancer
The "Pink Ribbon Sunday: Quality Mammography Saves Lives" campaign targets Hispanic and African-American women with messages about mammography services and breast cancer awareness. This initiative, which launched in Houston, reached approximately 110,000 people on one Sunday. Pink Ribbon Sunday continues to move across the country.
This year OWH partnered with 1,600 local churches across the country as well as more than 50 member organizations of the Puerto Rico Alliance to hold breast cancer awareness events and distribute educational literature. OWH also partnered with the National Conference of Mayors and the National Cancer Institute to distribute a new publication titled "Understanding Breast Changes" to women seeking services from the 9,000 FDA-certified mammography facilities across the nation.
Breaking News ... Dear Abby has just informed us that she will announce the availability of a "women's health kit" comprised of FDA's Take Time to Care Materials this June.
Food and Drug Administration
Office of Women's Health
10903 New Hampshire Avenue
Silver Spring , MD 20993