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Mifepristone, also known by its developmental code name RU-486, is a medication typically used in combination with misoprostol to bring about a medical abortion during pregnancy and manage early miscarriage. This combination is 97% effective during the first 63 days of pregnancy. It is also effective in the second trimester of pregnancy. It is taken by mouth.
The Comstock Act of 1873 is a series of current provisions in Federal law that generally criminalize the involvement of the United States Postal Service, its officers, or a common carrier in conveying obscene matter, crime-inciting matter, or certain abortion-related matter. The Comstock Act is largely codified across title 18 of the United States Code and was enacted beginning in 1872 with the attachment of an extraneous rider to a postal service reconsolidation bill. Amended multiple times since initial enactment, most recently in 1996, the Act is nonetheless often associated with U.S. Postal Inspector and anti-vice activist Anthony Comstock.
In the United States, abortion is a divisive issue in politics and culture wars, though a majority of Americans support access to abortion. Abortion laws vary widely from state to state.
A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
Walgreen Company is an American company that operates the second-largest pharmacy store chain in the United States, behind CVS Health. It specializes in filling prescriptions, health and wellness products, health information, and photo services. It was founded in Chicago in 1901, and is headquartered in the Chicago suburb of Deerfield, Illinois. On December 31, 2014, Walgreens and Switzerland-based Alliance Boots merged to form a new holding company, Walgreens Boots Alliance. Walgreens became a subsidiary of the new company, which retained its Deerfield headquarters and trades on the Nasdaq under the symbol WBA.
Gedeon Richter Plc. is a European multinational pharmaceutical and biotechnology company headquartered in Budapest. It is the largest pharmaceutical company in Central and Eastern Europe, with an expanding direct presence in Western Europe, China, Northern America and Latin America. Richter has the largest R&D unit in Central and Eastern Europe and operations in over 100 countries.
Roussel Uclaf S.A. was a French pharmaceutical company and one of several predecessor companies of today's Sanofi.
Apotex Inc. is a Canadian pharmaceutical corporation. Founded in 1974 by Barry Sherman, the company is the largest producer of generic drugs in Canada, with annual sales exceeding CA$2.5 billion. By 2023, Apotex employed close to 8,000 people as Canada's largest drug manufacturer, with over 300 products selling in over 115 countries. Apotex manufactures and distributes generic medications for a range of diseases and health conditions that include cancer, diabetes, high cholesterol, glaucoma, infections and blood pressure.
Danco Laboratories is a pharmaceutical distributor located in midtown Manhattan which distributes the abortifacient drug mifepristone under the brand name Mifeprex. Mifeprex is the only drug distributed by Danco, although the company plans to expand to other drugs in the future.
Purdue Pharma L.P., formerly the Purdue Frederick Company (1892–2019), was an American privately held pharmaceutical company founded by John Purdue Gray. It was sold to Arthur, Mortimer, and Raymond Sackler in 1952, and then owned principally by the Sackler family and their descendants.
FDA preemption is the legal theory in the United States that products licensed or otherwise approved for use by the Food and Drug Administration (FDA) are exempt from various state efforts to preclude their use. It has been raised as a counter to both direct efforts to ban such products, and as a defense against tort claims regarding such products. The doctrine hinges on the assertion of Congressional intent to designate FDA as the national clearinghouse for determinations of the safety of pharmaceutical products, and the Supremacy Clause of the Constitution of the United States placing federal law over state law.
Corcept Therapeutics Inc. is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, psychiatric and oncologic disorders. Corcept has focused on the adverse effects of excess cortisol, studying new compounds that may mitigate those effects. Its executive team is headed by CEO, president and director Joseph K. Belanoff, MD.
A medical abortion, also known as medication abortion or non-surgical abortion, occurs when drugs (medication) are used to bring about an abortion. Medical abortions are an alternative to surgical abortions such as vacuum aspiration or dilation and curettage. Medical abortions are more common than surgical abortions in most places around the world.
Matthew Joseph Kacsmaryk is an American lawyer who serves as a United States district judge in the United States District Court for the Northern District of Texas. He was nominated to the position by President Donald Trump in 2017 and sworn in for the position in 2019.
Aid Access is a nonprofit organization that provides access to medication abortion by mail to the United States and worldwide. It describes its work as a harm reduction strategy designed to provide safe access to mifepristone and misoprostol for those able to become pregnant in the United States who may not otherwise have access to abortion or miscarriage management services. People are able to manage their own abortion with remote access to a physician and a help-desk for any questions. The website is available in English, Spanish, and Dutch.
As of 2024, abortion is illegal in Indiana. It is only legal in cases involving fatal fetal abnormalities, to preserve the life and physical health of the mother, and in cases of rape or incest up to 10 weeks of pregnancy. Previously abortion in Indiana was legal up to 20 weeks; a near-total ban that was scheduled to take effect on August 1, 2023, was placed on hold due to further legal challenges, but is set to take place, after the Indiana Supreme Court denied an appeal by the ACLU, and once it certifies a previous ruling that an abortion ban doesn't violate the state constitution. In the wake of the 2022 Dobbs Supreme Court ruling, abortion in Indiana remained legal despite Indiana lawmakers voting in favor of a near-total abortion ban on August 5, 2022. Governor Eric Holcomb signed this bill into law the same day. The new law became effective on September 15, 2022. However, on September 22, 2022, Special Judge Kelsey B. Hanlon of the Monroe County Circuit Court granted a preliminary injunction against the enforcement of the ban. Her ruling allows the state's previous abortion law, which allows abortions up to 20 weeks after fertilization with exceptions for rape and incest, to remain in effect.
Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024), was a United States Supreme Court case to challenge the U.S. Food and Drug Administration (FDA)'s approval of mifepristone, a drug frequently used in medical abortion procedures. The plaintiffs, led by the Alliance for Hippocratic Medicine (AHM), argued that the FDA did not properly approve the use of the drug mifepristone for pregnancy termination under Federal Food, Drug, and Cosmetic Act regulations and asked for an injunction to withdraw the drug's approval, thus removing it from the market. AHM's suit followed the Supreme Court's ruling in Dobbs v. Jackson Women's Health Organization in 2022, which reversed Roe v. Wade and asserted there was no constitutional right to abortion at the federal level, leading conservative states and groups to further restrict abortion access.
Mayday Health is a 501(c)(3) non-profit organization that educates on medication abortion and how to access it in the United States. It was founded in 2022 in response to the Dobbs v. Jackson (2022) court decision that limited access to abortion in many U.S. states. Mayday educates on self-managed abortion and does not sell or distribute the abortion pill. Mayday was founded after the leak of the Dobbs v. Jackson decision that overturned Roe v. Wade (1973) and Planned Parenthood v. Casey (1992). The organization launched on the day of the Dobbs decision.
Exelgyn is a French pharmaceutical company which makes and distributes the medical abortion drugs mifepristone and misoprostol.
References
- ↑ "Generic abortion pill manufacturer sues FDA in effort to preserve access" Sarah McCammon April 19, 2023 NPR https://www.npr.org/2023/04/19/1170806176/abortion-pill-mifepristone-supreme-court-fda-generic-genbiopro
- "Abortion Pill Maker Sues F.D.A. to Protect Drug if a Court Orders It Off the Market" By Pam Belluck April 19, 2023 New York Times, https://www.nytimes.com/2023/04/19/health/abortion-pill-genbiopro-mifepristone.html