DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 02-12

FDA Web site: www.fda.gov

Revised: December 2003

Protecting the Health of Women:

How the FDA Serves Women’s Health Care Needs

Some of the brightest highlights

of the FDA’s long history are actions to protect the health of

women. The FDA created the Office of Women’s Health (OWH) in

1994 to advocate for women and

serve as a champion for women’s

health. Over the years, the agency

has addressed the health issues of

the nation’s largest population

group by providing scientific and

policy input on issues that face

women, funding research and education/outreach programs, and encouraging industry to include

women in clinical trials. The FDA

achieves this through consumer

information, product approvals,

research requirements, and support for studies.

Women’s health activities have

included the FDA’s first package

insert with information for consumers, issued in 1971 to explain

the benefits and risks of oral contraceptives; marketing approvals

for such landmark products as the

first over-the-counter pregnancy

test kit; and an effective public

health campaign that helped reduce the incidence of toxic shock

in women who use tampons to

five cases and no deaths in 1997.

One of the FDA’s most significant recent actions was a rule issued in 2000 enabling the agency

to halt studies of new drugs to

treat life-threatening diseases if

those clinical trials exclude

women participants solely because

they could become pregnant. After

passage of the Mammography

Quality Standards Act of 1992,

the FDA announced high standards designed to ensure that all

mammograms are of the highest

quality and initiated regular inspections of the over 9,100 mammography facilities in the United

States.

In addition, the agency has

launched several innovative programs for women:

• OWH has been highly recognized for “Take Time To Care,”

an award-winning FDA grassroots campaign on safe medication use, diabetes, and menopausal hormone therapy. The

office communicates these important health messages through brochures, fact sheets, the OWH Web

site, and quarterly updates, primarily to women over 45 in underserved communities.

• The Take Time To Care About

Diabetes campaign of 2002 addressed the looming epidemic of

diabetes, a condition that affects

17 million Americans, more than

half women. The diabetes campaign will be launched in 10 new

cities in February 2004.

• A menopausal hormone

therapy information campaign

was launched nationwide in September 2003 in collaboration with

other agencies and women’s

health organizations to distribute

materials that women can use as

tools to gain a better understanding of the health risks and benefits

of hormone therapy.

• Preventing the spread of HIV:

The FDA requires that HIV drug

labels include information on how

to prevent the transmission of the

disease from mother to infant.

• The Pink Ribbon Sunday

mammography initiative, an outreach program that targets African

American and Hispanic women

across the country.

• Fact sheets: OWH developed

fact sheets on a variety of topics

such as menopausal hormone

therapy, mammography, food

safety, Botox, tattoos, and sunscreen.

• Pregnancy labeling initiative:

The FDA developed a Pregnancy

Registry Web site to encourage

pregnant women to participate in

these important studies.

For more information, contact

the FDA’s Office of Women’s

Health at (301) 827-0350

(www.fda.gov/womens) or visit the

National Women’s Health Information Center at www.4woman.gov.

New Products for Women

In 2002-2003, the FDA approved

several important products for

women, including drugs to treat

metastatic breast cancer, two barrier

contraceptive devices, and low dose

hormonal products to treat symptoms of menopause.