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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

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

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

“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

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

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

Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993)

In its 1993 decision Daubert v. Merrell Dow Pharmaceuticals, Inc., the US Supreme Court established the Daubert Standard for evaluating the admissibility of scientific knowledge as evidence in US federal courts. When it began in trial court, the case addressed whether or not Bendectin, an anti-nausea medication taken during pregnancy, caused birth defects. However, after the trial court dismissed the case for lack of admissible evidence, Daubert v. Merrell Dow Pharmaceuticals, Inc.

Format: Articles

Subject: Legal

Sindell v. Abbott Laboratories (1980)

Sindell v. Abbott Laboratories was a 1980 California case that established the doctrine of market share liability for personal injury cases. For such liability, when a drug causes personal injury and the manufacturer of the drug cannot be identified, each producer is responsible for paying the settlement in proportion to the percentage of the market they supplied. Judith Sindell and Maureen Rogers brought the case against the producers of diethylstilbestrol (DES), which their mothers had taken during pregnancy to prevent miscarriage and other complications.

Format: Articles

Subject: Legal

California Proposition 71 (2004)

The California Stem Cell Research and Cures Act, also called Proposition 71, was a ballot
initiative proposed by California voters in 2004 to allocate three billion dollars of state
funds for stem cell research over ten years. Endorsed by California scientists and
patient-advocates, Prop 71 passed on 2 November 2004, amending the state constitution to make
stem cell research a constitutional right. In addition, Prop 71 led to the creation of the
California Institute for Regenerative Medicine (CIRM), in San Francisco, California to allocate

Format: Articles

Subject: Legal

US Endocrine Disruptor Screening Program

In 1996, the US Congress mandated that the US Environmental Protection Agency (EPA) create and regulate the Endocrine Disruptor Screening Program. The program tests industrial and agricultural chemicals for hormonal impacts in humans and in wildlife that may disrupt organisms' endocrine systems. The endocrine system regulates the release of small amounts of chemical substances called hormones to keep the body functioning normally.

Format: Articles

Subject: Disorders, Legal, Ethics

Social Implications of Non-Invasive Blood Tests to Determine the Sex of Fetuses

By 2011, researchers in the US had established that non-invasive blood tests can accurately determine the gender of a human fetus as early as seven weeks after fertilization. Experts predicted that this ability may encourage the use of prenatal sex screening tests by women interested to know the gender of their fetuses. As more people begin to use non-invasive blood tests that accurately determine the sex of the fetus at 7 weeks, many ethical questions pertaining to regulation, the consequences of gender-imbalanced societies, and altered meanings of the parent-child relationship.

Format: Articles

Subject: Reproduction, Ethics, Legal

Title X Family Planning Program (1970–1977)

The Family Planning Services and Public Research Act of 1970, often called Title X Family Planning Program, is a US federal law that provides federal funding for family planning services to low income or uninsured families. The US federal government passed the law, Public Law 91-572, in 1970 as an amendment to the Public Health Services Act of 1944. The Act created the Office of Population Affairs (OPA) under the Secretary of Health, Education, and Welfare (here called the Secretary).

Format: Articles

Subject: Reproduction, Legal

Ferguson v. City of Charleston (2001)

The US Supreme Court case Ferguson v. City of Charleston (2001) established that public hospitals couldn't legally drug test pregnant women without their consent when those women sought prenatal care at those hospitals. The court held that such searches violated the pregnant women's protections under the Fourth Amendment to the US Constitution. The decisions also indicated those circumstances that qualified as special needs exceptions to the Fourth Amendment, and it highlighted the extent to which pregnant women are sovereign individuals in the eyes of the Court. Ferguson v.

Format: Articles

Subject: Legal

"Ethical Issues in Human Stem Cell Research: Executive Summary" (1999), by the US National Bioethics Advisory Commission

Ethical Issues in Human Stem Cell Research: Executive Summary was published in September 1999 by The US National Bioethics Advisory Commission in response to a national debate about whether or not the US federal government should fund embryonic stem cell research. Ethical Issues in Human Stem Cell Research recommended policy to US President William Clinton's administration, which advocated for federal spending on the use of stem research on stem cells that came from embryos left over from in vitro fertilization (IVF) fertility treatments.

Format: Articles

Subject: Legal, Ethics

Bowen v. American Hospital Association (1986)

The 1986 US Supreme Court decision Bowen v. American Hospital Association rejected the federal government's use of Section 504 of the Rehabilitation Act of 1973 to intervene in a hospital's treatment for neonates born with severe congenital defects. This case set a precedent for the role of government involvement in cases where parents refused consent for care of disabled newborns.

Format: Articles

Subject: Legal, Reproduction

Commonwealth v. Luceba Parker [Brief] (1845)

The Court settled the question left open from the case of Commonwealth v. Bangs that it must be proved a woman was "quick with child" in order for abortion prohibitions to have any effect in Massachusetts.

Format: Articles

Subject: Legal, Reproduction

Burwell v. Hobby Lobby (2014)

In the 2014 case Burwell v. Hobby Lobby, the US Supreme Court ruled that the contraceptive mandate promulgated under the Patient Protection and Affordable Care Act violated privately held, for-profit corporations’ right to religious freedom. The contraception mandate, issued in 2012 by the US Department of Health and Human Services, required that employer-provided health insurance plans offer their beneficiaries certain contraceptive methods free of charge.

Format: Articles

Subject: Legal, Reproduction

George W. Bush Executive Order 13455, June 2007

On 20 January 2001, Republican George W. Bush was sworn in as the forty-third president of the United States, replacing Democrat William J. Clinton. During his eight years in office, Bush issued many executive orders, often altering previous policy. By signing Order 13435 on 22 June 2007, he changed how stem cell research would be performed in America.

Format: Articles

Subject: Legal

President George W. Bush's Announcement on Stem Cells, 9 August 2001

On 9 August 2001, US President George W. Bush gave an eleven-minute speech from his ranch in Crawford, Texas, on the ethics and fate of federal funding for stem cell research. Bush also announced the creation of a special council to oversee stem cell research. In the speech President Bush acknowledged the importance of issues surrounding stem cell research to many Americans, presented different arguments in favor of and opposing embryonic stem cell research, and explained his decision to limit but not completely eliminate potential federal funding for embryonic stem cell (ESC) research.

Format: Articles

Subject: Legal

Thomson, et al. v. Thompson, et al. (2001)

Thomson, et al. v. Thompson, et al. was a lawsuit filed in the United States District Court for the District of Columbia on 8 May 2001 as Civil Action Number 01-CV-0973. This lawsuit was filed in hopes of gaining injunctive relief against a moratorium on the federal funding of stem cell research. The plaintiffs in the case were seven prominent scientists who performed embryonic stem cell research and three patients: James Thomson, Roger Pedersen, John Gearhart, Douglas Melton, Dan Kaufman, Alan Trounson, Martin Pera, Christopher Reeve, James Cordy, and James Tyree.

Format: Articles

Subject: Legal

Eugenical Sterilization in the United States (1922), by Harry H. Laughlin

Eugenical Sterilization in the United States is a 1922 book in which author Harry H. Laughlin argues for the necessity of compulsory sterilization in the United States based on the principles of eugenics. The eugenics movement of the early twentieth century in the US focused on altering the genetic makeup of the US population by regulating immigration and sterilization, and by discouraging interracial procreation, then called miscegenation.

Format: Articles

Subject: Outreach, Legal, Ethics, Publications

In re Agent Orange Product Liability Litigation (1979-1984)

In the legal case In re Agent Orange Product Liability Litigation of the early 1980s, US military veterans of the Vietnam War sued the US chemical companies that had produced the herbicide Agent Orange, and those companies settled with US veterans out of court. Agent Orange contains dioxin, a chemical later shown to disrupt the hormone system of the body and to cause cancer. As veterans returned to the US from Vietnam, scientists further confirmed that exposure to Agent Orange caused a variety of cancers in veterans and developmental problems in the veterans' children.

Format: Articles

Subject: Legal, Ethics

The Baby Doe Rules (1984)

The Baby Doe Rules represent the first attempt by the US government to directly intervene in treatment options for neonates born with congenital defects. The name of the rule comes from the controversial 1982 case of a Bloomington, Indiana infant Baby Doe, a name coined by the media. The Baby Doe Rules mandate that, as a requirement for federal funding, hospitals and physicians must provide maximal care to any impaired infant, unless select exceptions are met. If a physician or parent chooses to withhold full treatment when the exceptions are not met, they are liable for medical neglect.

Format: Articles

Subject: Legal, Reproduction

Whitner v. South Carolina (1997)

In the case Whitner v. South Carolina in 1997, the South Carolina State Supreme Court defined the concept of a child to include viable fetuses. This allowed grounds for prosecution of a pregnant womanÕs prenatal activity if those activities endangered or could potentially endanger the fetus within her. The case brought the issue of fetal rights versus pregnant womenÕs rights to light.

Format: Articles

Subject: Legal, Reproduction

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