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Displaying 26 - 38 of 38 items.

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

Sheppard-Towner Maternity and Infancy Protection Act (1921)

In November 1921, US Congress passed the National Maternity and Infancy Protection Act, also called the Sheppard-Towner Act. The Act provided federal funds to states to establish programs to educate people about prenatal health and infant welfare. Advocates argued that it would curb the high infant mortality rate in the US.

Format: Articles

Subject: Legal, Outreach

Dickey-Wicker Amendment, 1996

The Dickey-Wicker Amendment is an amendment attached to the appropriations bills for the Departments of Health and Human Services, Labor, and Education each year since 1996 restricting the use of federal funds for creating, destroying, or knowingly injuring human embryos. The Dickey-Wicker Amendment began as a rider (another name for an amendment) attached to House Resolution (H.R.) 2880. H.R.

Format: Articles

Subject: Legal

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

Freedom of Access to Clinic Entrances Act (1994)

On 26 May 1994, US President Bill Clinton signed the Freedom of Access to Clinic Entrances Act in to law, which federally criminalized acts of obstruction and violence towards reproductive health clinics. The law was a reaction to the increasing violence toward abortion clinics, providers, and patients during the 1990s. That violence included clinic blockades and protests, assaults on physicians and patients, and murders. The Freedom of Access to Clinic Entrances Act established

Format: Articles

Subject: 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

China's One-Child Policy

In September 1979, China's Fifth National People's Congress passed a policy that encouraged one-child families. Following this decision from the Chinese Communist Party (CCP), campaigns were initiated to implement the One-Child Policy nationwide. This initiative constituted the most massive governmental attempt to control human fertility and reproduction in human history. These campaigns prioritized reproductive technologies for contraception, abortion, and sterilization in gynecological and obstetric medicine, while downplaying technologies related to fertility treatment.

Format: Articles

Subject: Ethics, Legal, Reproduction

Golden Rice

Golden Rice was engineered from normal rice by Ingo Potrykus and Peter Beyer in the 1990s to help improve human health. Golden Rice has an engineered multi-gene biochemical pathway in its genome. This pathway produces beta-carotene, a molecule that becomes vitamin A when metabolized by humans. Ingo Potrykus worked at the Swiss Federal Institute of Technology in Zurich, Switzerland, and Peter Beyer worked at University of Freiburg, in Freiburg, Germany. The US Rockefeller Foundation supported their collaboration.

Format: Articles

Subject: Organisms, Legal

Litowitz v. Litowitz [Brief] (2002)

Pursuant to an express provision of the embryo disposition contract they both signed, a husband and wife had to petition the court for instructions because they could not reach an agreement about what to do with frozen embryos when they divorced. The trial court awarded the pre-embryos to the husband and the Court of Appeals affirmed this decision. However, the Washington Supreme Court ruled that the pre-embryos should be thawed out and allowed to expire because the dispute had not been resolved within a five year time frame prescribed by the Cryopreservation Agreement.

Format: Articles

Subject: Legal, Reproduction

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

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

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

City of Akron v. Akron Center for Reproductive Health (1983)

In the 1983 case City of Akron v. Akron Center for Reproductive Health the US Supreme Court ruled that certain requirements of the city of Akron’s “Regulation on Abortion” ordinance violated women’s rights to abortions. Despite the legalization of abortion in the 1973, with the US Supreme Court case Roe v. Wade, individual states passed legislation regulating certain aspects of abortion.

Format: Articles

Subject: Legal