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The Food and Drug Administration’s Pregnancy and Lactation Labeling Rule (2014)

In 2014, the United States Food and Drug Administration published the Pregnancy and Lactation Labeling Rule to amend previous guidelines for the prescription of drugs for pregnant and lactating women. The 2014 Pregnancy and Lactation Labeling Rule was intended to increase the safety and efficacy of prescription drugs by making drug labels easier for physicians to understand and utilize.

Format: Articles

Subject: Legal

“General Considerations for the Clinical Evaluation of Drugs” (1977), by the United States Food and Drug Administration

The United States Food and Drug Administration, or FDA, published 'General Considerations for the Clinical Evaluation of Drugs,' in September 1977. The document defined acceptable practices for investigators who studied new drugs. Specifically, the document outlined the common clinical trial methods. Clinical trials are studies to test whether a new drug is safe before doctors can prescribe it to patients. Prior to 1977, the Protection of Human Subjects Rule primarily regulated clinical drug trials, but it did not specify who could and could not be included in clinical trials.

Format: Articles

Subject: Publications

Thesis: A History and Analysis of Drug Labeling Policy for Pregnant and Lactating Women and Women's Involvement in Clinical Drug Research from 1970 to 2014

The problem of whether women should be involved in drug research is a question of who can assume risk and who is responsible for disseminating what specific kinds of information. The problem tends to be framed as one that juxtaposes the health of women and fetuses and sets their health as in opposition. That opposition, coupled with the inherent uncertainty in testing drugs, provides for a complex set of issues surrounding consent and access to information.

Format: Essays and Theses

Subject: Ethics

“Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs” (July 1993), by the United States Food and Drug Administration

The US Food and Drug Administration, or FDA, published the “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” henceforth “Study of Gender Differences,” in July 1993. The document defined acceptable practices for investigators studying new drugs. Prior to 1993, investigators excluded most women from clinical trials because in 1977, the FDA recommended that anyone who could possibly become pregnant be excluded from early phase drug research to minimize risk to a potential fetus.

Format: Articles

Subject: Publications

Physician Labeling Rule (2006)

In 2006, the United States Food and Drug Administration, or FDA, published the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” also called the Physician Labeling Rule, to improve the safety and efficacy of prescription drugs and drug products. Within the Physician Labeling Rule, the FDA includes a section titled “Use in Specific Populations” or Section 8, which refers to drugs used by pregnant women, lactating women, and people of reproductive capacity.

Format: Articles

Subject: Legal

Retinoids As Teratogens

Vitamin A (retinol) is an essential vitamin in the daily functioning of human beings that helps regulate cellular differentiation of epithelial tissue. Studies have shown that an excess of vitamin A can affect embryonic development and result in teratogenesis, or the production of birth defects in a developing embryo. Excess intake of vitamin A and retinoids by pregnant women often results malformations to fetuses' skulls, faces, limbs, eyes, central nervous system.

Format: Articles

Subject: Disorders, Reproduction

US Regulatory Response to Thalidomide (1950-2000)

Thalidomide, a drug capable of causing fetal abnormalities (teratogen), has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did. By 1962, approximately 20,000 patients in the US had taken thalidomide as part of an unregulated clinical trial before any actions were taken to stop thalidomide's distribution.

Format: Articles

Subject: Legal, Reproduction

World Health Organization Guidelines (Option A, B, and B+) for Antiretroviral Drugs to Treat Pregnant Women and Prevent HIV Infection in Infants

To address the international Human Immunodeficiency Virus epidemic, the World Health Organization, or WHO, developed three drug treatment regimens between 2010 and 2012 specifically for HIV-positive pregnant women and their infants. WHO developed the regimens, calling them Option A, Option B, and Option B+, to reduce or prevent mother-to-child, abbreviated MTC, transmission of HIV. Each option comprises of different types and schedules of antiretroviral medications. As of 2018, WHO reported that in Africa alone about 1,200,000 pregnant women were living with untreated HIV.

Format: Articles

Subject: Reproduction, Processes, Disorders

The Development of Mifepristone for Use in Medication Abortions

In the 1980s, researchers at the pharmaceutical company Roussel-Uclaf in Paris, France, helped develop a biological compound called mifepristone. When a woman takes it, mifepristone interferes with the function of hormones involved in pregnancy and it can therefore be used to terminate pregnancies. In 2000, the US Food and Drug Administration approved mifepristone, also called RU 486, as part of a treatment to induce abortions using drugs instead of surgery, a method called medication abortion.

Format: Articles

Subject: Reproduction

“Improving Women’s Health”: Section 3509 of the Affordable Care Act of 2010

In 2010, US Congress enacted section 3509 of the Patient Protection and Affordable Care Act or ACA, to target issues relating to women’s health. The ACA, signed into law by US President Barack Obama, aimed to increase people’s access to high-quality healthcare in the United States.

Format: Articles

Subject: Legal

Plan B: Emergency Contraceptive Pill

Plan B is a progestin-only emergency contraceptive pill (ECP) that can be taken within seventy-two hours of unprotected sex in order to prevent an unwanted pregnancy. Plan B was created in response to the United States Food and Drug Administration's (US FDA) 1997 request for new drug applications (NDAs) for a dedicated ECP product, and was approved for sales in the US in 1999. Duramed, a subsidiary of Barr Pharmaceuticals, manufactures Plan B for The Women's Capital Corporation (WCC), which owns the patent for Plan B.

Format: Articles

Subject: Technologies, Reproduction

International Treaty on Plant Genetic Resources for Food and Agriculture (2001)

The International Treaty on Plant Genetic Resources for Food and Agriculture, referred to as the Plant Treaty, was approved on 3 November 2001 by Members of the Food and Agriculture Organization (FAO), headquartered in Rome, Italy. The FAO is an agency of the United Nations, headquartered in New York City, New York. The Plant Treaty established international standards for the conservation and exchange of plant genetic material between participating countries.

Subject: Legal

The Dalkon Shield

The Dalkon Shield was an intrauterine contraceptive device (IUD) that women used in the early 1970s and 1980s. Produced by the A.H. Robins Company in the US, the Dalkon Shield was a contraceptive device placed directly into a woman’s uterus that was supposed to prevent the development of a fetus in the uterus. In the 1980s, researchers uncovered an array of severe birth defects and injuries caused by the Dalkon shield, including pelvic infection, infertility, and death of the user. Eventually the A.H.

Format: Articles

Subject: Technologies

Diethylstilbestrol (DES) in the US

Diethylstilbestrol (DES) is an artificially created hormone first synthesized in the late 1930s. Doctors widely prescribed DES first to pregnant women to prevent miscarriages, and later as an emergency contraceptive pill and to treat breast cancer. However, in 1971, physicians showed a link between DES and vaginal cancer during puberty in the children of women who had taken DES while pregnant. Consequently, the US Food and Drug Administration (FDA) banned its use during pregnancy.

Format: Articles

Subject: Reproduction, Technologies

Leuprorelin as a Treatment for Endometriosis

Leuprolide acetate, or leuprorelin, is a manufactured drug that has been prescribed as a treatment for endometriosis, a medical condition in which body tissue that typically lines the uterus grows outside of the uterus, since 1989. Leuprorelin is a modified version of a gonadotropin-releasing hormone, a type of hormone that helps regulate the female menstrual cycle. The drug inhibits the production of estrogen, a female sex hormone that enables endometrial gland growth.

Format: Articles

Subject: Processes

Gardasil HPV Vaccination Series

In 2006, United States pharmaceutical company Merck released the Gardasil vaccination series, which protected recipients against four strains of Human Papillomaviruses, or HPV. HPV is a sexually transmitted infection which may be asymptomatic or cause symptoms such as genital warts, and is linked to cervical, vaginal, vulvar, anal, penile, head, neck, and face cancers.

Format: Articles

Subject: Technologies

NovaSure Endometrial Ablation

NovaSure is a device for endometrial ablation, which is a procedure that removes the endometrium, that the US Food and Drug Administration, or FDA, approved for use on 28 September 2001. Endometrium is the tissue that lines the uterus. NovaSure destroys the endometrium by sending electric beams at the endometrium. Hologic, a medical technology company concerned with women’s health, developed NovaSure to treat menorrhagia, or heavy bleeding during menstruation. Menorrhagia is a common symptom of endometriosis. Endometriosis is the growth of the endometrium outside of the uterus.

Format: Articles

Subject: Technologies

The Birth Control Pill

The birth control pill, more commonly known as "the pill" is a form of contraception taken daily in pill form and consisting of synthetic hormones formulated to prevent ovulation, fertilization, and implantation of a fertilized egg. The US Food and Drug Administration (FDA) approved the first birth control pill, Enovid, in June 1960. It was the first contraceptive pill marketed worldwide. Since then a number of different pills have been developed, which differ in hormone type and dosage, and whether they contain one hormone (the minipill) or two (the combination pill).

Format: Articles

Subject: Technologies, Reproduction

Cervarix HPV Vaccination Series

In 2011, United Kingdom pharmaceutical company GlaxoSmithKline released Cervarix, a vaccination series protecting girls and women from two strains of Human Papillomavirus, or HPV. HPV, a sexually transmitted infection, can present in men and women without symptoms, or may cause symptoms such as genital warts. There is a link between HPV and cervical, vaginal, anal, head, neck, and face cancers, and Cervarix can reduce genital cancers in girls and women, particularly cervical cancer.

Format: Articles

Subject: Technologies

Zidovudine or Azidothymidine (AZT)

In 1964, Jerome Horwitz synthesized the drug zidovudine, commonly abbreviated ZDV, otherwise known as azidothymidine, or AZT, at Wayne State University School of Medicine in Detroit, Michigan. Horwitz and his colleagues originally developed zidovudine to treat cancers caused by retroviruses. In 1983, Nobel Prize in Physiology or Medicine recipients Françoise Barré-Sinoussi and Luc Montagnier discovered a new retrovirus, the human immunodeficiency virus, or HIV, at the Pasteur Institute in Paris, France.

Format: Articles

Subject: Processes

Title 1, Subtitle B, Parts I, II, and III of the “National Institutes of Health Revitalization Act of 1993” (1993)

In 1993, the NIH published the Revitalization Act that established guidelines for minorities’ and women’s participation in clinical research. Before the 1990s, investigators largely excluded women from their research based on the 1979 guidance from the US Food and Drug Administration, or FDA. The FDA urged investigators to exclude any woman who was or could become, pregnant to protect the woman and any developing fetuses from harm.

Format: Articles

Subject: Legal

Clomiphene Citrate

Clomiphene citrate, more commonly known by its brand names Clomid and Serophene, is a medication prescribed to women to stimulate ovulation in order to treat infertility. It stimulates ovulation in women who do not ovulate or ovulate irregularly. This drug was created by Dr. Frank Palopoli in 1956 while he worked for Merrell Company. It first successfully induced ovulation in women in 1961 and was approved by the Federal and Drug Administration (FDA) in 1967.

Format: Articles

Subject: Technologies

Frazer v. Schlegel (2007)

On 20 August 2007, in Frazer v. Schlegel, the United States Court of Appeals for the Federal Circuit decided that researchers Ian Frazer and Jian Zhou owned the rights to the vaccine patent for Human Papillomavirus, or HPV, instead of a research team led by Richard Schlegel. Frazer v. Schlegel reversed the decision that the Board of Patent Appeals and Interferences had previously made, awarding the patent to Schlegel on the basis that Frazer’s patent application contained inaccurate science.

Format: Articles

Subject: Legal, Technologies

Stem Cell Tourism

When James Thomson of the University of Wisconsin announced in 1998 that he had derived and cultured human embryonic stem cells(hESCs), Americans widely believed-and accepted-that stem cells would one day be the basis of a multitude of regenerative medical techniques. Researchers promised that they would soon be able to cure a variety of diseases and injuries such as cancer, diabetes, Parkinson's, spinal cord injuries, severe burns, and many others. But it wasn't until January 2009 that the Food and Drug Administration approved the first human clinical trials using hESCs.

Format: Articles

Subject: Theories, Ethics

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