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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. [2]
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.
Mifepristone was developed in 1980 and came into use in France in 1987. [16] It became available in the United States in 2000, for medication abortion, and in 2010, for Cushing's syndrome. [17] [10] [12] It is on the World Health Organization's List of Essential Medicines. [18] Mifepristone was approved in Canada in January 2017. [19] [20]
Hoeschst AG transferred all rights for medical uses of mifepristone (outside of the United States) to Exelgyn. [2] In 1999, Exelgyn won approval of Mifegyne in 11 additional countries. [3] As of 2024, Exelgyn distributes mifepristone to 40 countries, [4] but within the United States it is distributed by Danco Laboratories and GenBioPro.
[159] [160] [161] Even so, several states in the US require providers of non-surgical abortion who use mifepristone to tell patients that reversal is an option. [162] In 2019, researchers initiated a small trial of the so-called "reversal" regimen using mifepristone followed by progesterone or placebo.
In 2000, GenBioPro's generic version of mifepristone was approved for medication abortion, as part of a two-drug regimen in combination with misoprostol. In 2023, GenBioPro sued the FDA to obtain a legal judgement confirming that mifepristone could continue to be sold, in spite of anti-abortion laws passed in some states.
Misoprostol is used for the prevention of NSAID-induced gastric ulcers.It acts upon gastric parietal cells, inhibiting the secretion of gastric acid by G-protein coupled receptor-mediated inhibition of adenylate cyclase, which leads to decreased intracellular cyclic AMP levels and decreased proton pump activity at the apical surface of the parietal cell.
Mifepristone was approved by the Food and Drug Administration (FDA) in September 2000. [2] Medication abortion accounts for over half of all abortions in the United States. [3] Under the 2000 approval, mifepristone was approved by the FDA under Congressional regulations granted to them by Subpart H of the FDA's mandate.