Danco Laboratories, a manufacturer of the abortion pill mifepristone, told the Supreme Court on Tuesday that restricting use of the medication would cause “tremendous harm” to women.
The legal kerfuffle over the FDA’s 2000 approval of Danco Laboratories’ abortion pill mifepristone, also known as Mifeprex, is heading to the Supreme Court.
NEW YORK, March 17, 2023 /PRNewswire/ -- Danco Laboratories forcefully defended the approval of Mifeprex® in a four-hour hearing held in federal court in Amarillo, Texas in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The plaintiffs in this case raise a series of meritless challenges to FDA's approval of Mifeprex®, including the agency's analysis of the drug's safety profile, which dates back to 2000, and to the REMS that has governed the distribution and use of Mifeprex since 2008. The hearing laid bare both the unprecedented nature of the plaintiffs' legal theory and the speculative nature of their factual allegations.
NEW YORK, Jan. 13, 2023 /PRNewswire/ -- Today, Danco Laboratories (Danco) filed a motion to intervene in Alliance for Hippocratic Medicine v. FDA, a lawsuit in which several anti-abortion organizations and four individual physicians asked a federal court to immediately suspend FDA's approval of Mifeprex®. If the judge grants the plaintiffs' request, it may block the availability of Mifeprex® for medication abortion nationwide as early as mid-February. Prescribers across the United States may not be able to prescribe Mifeprex® to their patients, because the drug could not be sold or shipped to certified healthcare providers. The plaintiffs filed this suit in the U.S. District Court for the Northern District of Texas, Amarillo Division, on November 18, 2022.
American women will have cheaper and easier access to abortion by medication after a decision by the Food and Drug Administration on Wednesday to relax restrictions on the use of abortion pill Mifeprex that were in place for over a decade.