### FDA Milestones in Women's Health*Looking Back as We Move into the New Millennium*

Every morning when you wake up and

brush your teeth

put in your contact lenses

microwave your breakfast

take your medicine

feed your pet

select a lipstick

go grocery shopping

get a flu shot or a mammogram....

You have been touched by the						U.S. Food and Drug Administration.

From the beginning of this century to the new millennium, events in women's health helped to strengthen the Food and Drug Administration (FDA). FDA's responsibilities have changed dramatically over time, often in response to public tragedies.

FDA regulates over 1 trillion dollars worth of products, which account for 25 cents of every dollar spent annually by American consumers. As America's oldest consumer protection agency, FDA regulates a wide array of products:
- our food supply (except for meat, poultry and eggs),			 medicines (human and animal),			medical devices and diagnostic products (such as pregnancy test kits),			
- radiation emitting devices (such as microwaves and televisions),			 vaccines, blood and tissue products, and			cosmetics.		
The FDA also makes sure that these products have accurate labels.
It is with the hope of conveying FDA's role in protecting women's and the public's health that the FDA Office of Women's Health produced this booklet. Due to the following milestones, all Americans can enjoy safer, healthier lives.
For this brochure, we chose products important to women throughout their lives and for different diseases and conditions. However, only the first of a kind is listed. Please note that mention of a product does not constitute an endorsement.
**Key FDA Vaccine Approvals**
**1945:***Influenza (flu) vaccine***1949-63:***Diphtheria, Tetanus, Pertussis (DTP); mumps and measles vaccines***1955-63:***Polio vaccines***1971:***German measles (rubella) vaccine***1977:***Pneumonia vaccine***1981:***Hepatitis B vaccine***1985:***Hemophilus vaccine***1996:***Varicella (chicken pox) vaccine					          Pertussis vaccine --New and improved with fewer side effects***1998:***Lyme disease vaccine*1902: Assuring Early Biological Products Safety
Problem: 13 children died from a product (an anti-toxin against Diphtheria) contaminated by tetanus microbes.

Response: Congress passed a law that required:
- inspections of the manufacturers and sellers of biological products, and			 testing of these products for purity and strength.		
Although not in existence at this time, FDA currently has these responsibilities.
**1906: Fighting Addictive "Medicines"**
Problem: Some syrups to calm colicky babies and "tonics" for women contained alcohol, opium, or morphine, addicting many who used them. Worthless, impure and dangerous patent medicines, and foods that were misrepresented or impure were on the market.

Response: Because of these problems, women organized to support the Food and Drugs Act of 1906. To protect the public's health, the law:
- created the first government regulatory agency--known today as the Food and Drug Administration (FDA),			 required dangerous ingredients to be labeled on all drugs, and			allowed for seizure of illegal foods and drugs.		
1933: Targeting More Dangers
An exhibit of dangerous food, medicines, medical devices and cosmetics was prepared to illustrate the shortcomings of the 1906 law. First Lady Eleanor Roosevelt took this exhibit to the White House and appealed to America's women to campaign for stronger protections for consumers.
**"America's Chamber of Horrors" Exhibit**
The famous exhibit included the following harmful products:
- A "womb supporter" (also used as a contraceptive) that could puncture the uterus if inserted the wrong way.						 A weight-loss drug that caused death.						A hair remover that caused baldness, even if not used on the head.						
- Lotions and creams that could cause mercury poisoning, and hair dyes that could cause lead poisoning.						 An eyelash dye that blinded women.					1937: Responding to Another Tragedy 
Problem: A company manufacturing one of the first wonder drugs against infection (sulfanilamide) dissolved it in a poisonous liquid. Before the problem was discovered, 107 people, mostly children, died. Until this time, there were no government regulations requiring that drugs be tested and found safe before going on the market.

Response: As a result, Congress passed the federal Food, Drug, and Cosmetic Act of 1938. The new law:
- required manufacturers to prove that a new drug was safe for its intended use when used under the conditions of the label, to include a full list of ingredients for a drug, and to show manufacturing was satisfactory.			 allowed regulation for the first time of cosmetics and medical devices, in addition to foods, drugs, and biological products; and			provided for food standards and detailed package labeling.		
****Key FDA Food Milestones******1940s**: *Iron added to breads, cereals and flour to prevent iron-deficiency anemia.***1980:***Congress passed the Infant Formula Act after low-chloride formula caused harm in infants.***1994:***New food labels required to provide clearly readable information on fat, cholesterol, dietary fiber and other key nutrients.***1997:***Food Safety Initiative took measures to reduce food contamination, such as with E. coli.***1998:***Folic acid required to be added to grain products to prevent neural tube defects in infants.*1960: Beginning a New Era in Women's Health
FDA approved the first oral contraceptive.
1961: Spurring Drug Reforms to Prevent Birth Defects
Problem: In Europe, approximately 10,000 infants born with deformed arms and legs were linked to thalidomide, a drug their mothers had taken during pregnancy

Response: Due to the efforts of a woman scientist, and drug reviewer Frances Kelsey, (M.D./ Ph.D.), FDA did not approve the drug for use in America. Worldwide alarm led to stronger drug laws here and in many other countries. In the U.S., the 1962 Kefauver-Harris Amendments to the federal Food, Drug, and Cosmetic Act of 1938:
- Required a drug to be tested in animals before being tested on people;			 Made investigators responsible for supervising drugs under study;			Required manufacturers to inform participants if a drug was being used for investigational purposes and obtain their consent;			
- Required that drugs be shown to work (be effective) before marketing;			 Required manufacturers to report unexpected harm (adverse events); and			Gave FDA authority to regulate advertising of prescription drugs.		
1968: Protecting Babies
To prevent complications in Rh negative mothers, FDA licensed Rh immunoglobulins.
1970: Providing Information for Women
FDA initiated the first package insert written for consumers to explain to women the benefits and potential risks of oral contraceptives.
1971: Issuing Warnings that Products are Unsafe for Pregnant Women
Problem: Since 1948, diethylstilbestrol (DES) had been prescribed (without the supporting scientific data) to thousands of pregnant women believed to need more estrogen to maintain their pregnancies. Exposed in the womb to DES, the daughters developed a rare form of vaginal cancer.
Response: FDA changed the labeling on this hormone to warn women against taking this drug during pregnancy.

**Women in Clinical Trials****1977:***After the tragedies caused by the use of thalidomide and DES in pregnant women, FDA guidance recommended against including women of child bearing potential in the early phases of drug testing except for life-threatening illnesses.***1993:***FDA issued a guideline calling for the study of drugs in both women and men in the evaluation of medicines. This guideline allowed the restriction on women of child bearing potential to be lifted and allowed them in early phase clinical trials. The 1993 guideline emphasized the need for representation of both women and men in clinical trials to allow detection of clinically significant gender/sex differences.***1998:***FDA published its final rule requiring New Drug Applications to examine and include data on safety and effectiveness by gender/sex, age and race.*
It is important to include women in clinical trials to determine how women and men respond to medicines. To be sure that medical products are safe and effective for all those who use them, these products should be tested in both women and men, and the data examined for differences in both favorable and unfavorable responses.1976: Strengthening Authority over Medical Devices
Problem: Approximately 2 million women had a contraceptive device, the Dalkon Shield IUD, inserted in their uteruses. Due to problems with this device, many women were seriously injured.

Response: In reacting to this tragedy, Congress passed the 1976 Medical Devices Amendments, which strengthened FDA's authority to oversee medical devices.

**Key FDA Device Actions****1978:***Approved first over-the-counter pregnancy test kit***1979:***Approved x-ray machine to measure bone mineral density***1985:***Permitted makers of latex condoms to add information to their labeling that their products protect against sexually transmitted diseases, including AIDS***1991-2:***Required manufacturers of silicone breast implants to submit data showing safety and effectiveness or have their product taken off the market. When adequate data was not demonstrated, FDA restricted the use of silicone gel-filled breast implants to those women with a medical need.***1994:***Approved first blood test to measure a tumor marker that can help determine if breast cancer has recurred.***1998:***Approved computerized devices to help analyze mammograms and pap smears.*1980: Making Tampon Use Safer
Problem: In 1980, there were 814 confirmed cases of menstrual related Toxic Shock Syndrome (TSS) and 38 deaths from the disease.

Response: FDA began requiring all tampon packages to include package inserts educating women about the risk of TSS and how to prevent it. In 1997, there were only five confirmed menstrually-related TSS cases and no deaths. The tampon package inserts with TSS information continue to be used today.
1982: Eliminating Lethal Tampering
Problem: Seven people died from Tylenol capsules intentionally contaminated with cyanide.

Response: FDA issued regulations requiring tamper-resistant packaging for over-the-counter drugs.
1992: Improving Mammograms
Problem: Women and their doctors testified before Congress about problems with mammography, including untrained personnel, old machines, and failure to communicate test results.

Response: Congress passed the Mammography Quality Standards Act (MQSA), which imposed standards for mammography personnel, equipment, record keeping, and regular FDA inspections of mammography facilities. FDA also started an information service to help women find a quality mammography facility through the National Cancer Institute toll-free phone number (1-800-4-CANCER).

**Key FDA Drug Actions****1942:***First product (conjugated estrogens) marketed for treatment of menopausal symptoms.***1967:***First drug approved for induction of ovulation to promote fertility.***1974:***Sequential oral contraceptives that increased the risk of endometrial cancer were withdrawn.***1977:***New types of drug that block estrogen receptor approved for treatment of patients with advanced breast cancer.***1987:***First of a new class of drugs (selective serotonin reuptake inhibitors [SSRIs]) approved for depression.***1988:***Birth control pills containing more than 50 micrograms of estrogen withdrawn from the market because of association with higher risk for rare, but fatal thromboembolisms.***1994:***Information on the prevention of transmission of the HIV virus from HIV+ pregnant women to their fetuses between 14 and 34 weeks included in the label of an antiretroviral drug.***1996:***President Clinton announced a new initiative to accelerate approval of cancer drugs by recognizing that tumor shrinkage is often an early indicator of effectiveness.***1997:***Additional drugs approved for prevention and treatment of osteoporosis.***1998:***FDA issued warnings about the dangers of mixing alcohol with pain relievers.*1994: Advocating for Women: Office of Women's Health
FDA created the Office of Women's Health (OWH), beginning a new chapter in this agency's commitment to women's health. Serving as a champion for women's health both inside and outside the agency, OWH safeguards the health and well being of American women in a variety of ways by:
- Providing scientific and policy input on many of today's leading women's health issues;			 Funding research and education/outreach programs on pressing women's conditions and diseases;			Encouraging industry to include women in their clinical trials; and			
- Communicating important public health messages to and from the public.		  OWH also provides information on women's health issues to Congress, the press, health professionals, women's health advocates, and the public, which can be found at their web site at http://www.fda.gov/womens.  1997: Launching a major program for women about medications: Take Time to Care  Problem: Studies indicated that 30 to 50 percent of Americans did not use their medicines correctly.  Response: The FDA Office of Women's Health developed Women's Health: Take Time To Care (TTTC), a public awareness campaign about safe use of medicines. By partnering with grassroots organizations, other federal agencies, state and local governments, and private industry, TTTC reached millions of women and their families with simple safety tips to help women become informed and active participants in making decisions for themselves and their whole families.  1998: Speeding up the approval process  Congress amended the Federal Food, Drug and Cosmetic Act by passing the Food and Drug Administration Modernization Act (FDAMA). With the passage of FDAMA, Congress enhanced the FDA's mission to meet the challenges of the 21st century, such as establishing mechanisms to decrease the time FDA takes to review and approve applications. This Act also called for FDA to receive input from its stakeholders.  1998-1999: Conferring with stakeholders  FDA held meetings across the country to exchange information with stakeholders on issues related to it's regulation drugs, biologics, medical devices, veterinary medicines, foods, inspections of manufacturers, and FDAMA.  Challenges at the FDA  FDA must make many difficult decisions in safeguarding the public's health. FDA works to maintain a strong scientific base to make these decisions and to balance benefits to the consumer against possible risks. FDA works with industry to get new products to market but with the goal of assuring the product is safe and works for you, the consumer.  More Progress to Come  FDA, as a scientific regulatory agency, is preparing to review new products and technologies that can dramatically improve health in the years ahead. These advances include genetic testing, miniaturization of devices for minimally intrusive surgery, vaccines that can be eaten, cloning, computers to assist in medical diagnoses, and different ways to take medicines.  Thanks to the American people and Congress, FDA has helped strengthen public health enormously during this century. In preparing for future progress, we will strive to make the 21st century even healthier for women and all Americans.  
**U.S. Women****1900's****1990's**Age at death48.3 years79 yearsPrimary causes of deathTB and child birthHeart diseaseAverage #children82 Infant mortality rates124-158 per 1,0007-14 per 1,000Number in workforceNot counted43%Eligible Voters0%52% of US Pop.ACKNOWLEDGEMENTS:
The Office of Women's Health would like to acknowledge the hard work of many people in creating this brochure during this millennium year. Marsha Henderson and Marietta Anthony in the Office of Women's Health, in particular, had the vision, inspiration, and tenacity to see the project through to completion, Suzanne Junod and the FDA History Office provided research and many of the photographs documenting FDA's work on behalf of women's health over its nearly one hundred year history. Other FDA colleagues reviewed the document carefully, offering ideas and document at various stages in the work: Wallace Adams, Julie Beitz, Ridgely Bennett, Shirley Blakely, Kathryn Carbone, Carolyn Deal, Patricia Delany, Elaine Esber, Jean Fourcroy, Elisa Harvey, Elizabeth McCarthy, Colin Pollard, William Rados, Deborah Ralston, Lisa Rarick, Peter Rheinstein, Kimber Richter, Linda Sherman, Robert Temple, Theresa Toigo, Judith Willis, and Elizabeth Yetley. Special thanks to Ellen Friebert, our program consultant and Carolyn Spencer, our graphic designer.

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FDA/Website Management StaffHypertext created by tg and clb 2000-FEB-22. Updated by zwr 18-JAN-2001