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U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine is a pending 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), argue 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 ask 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 to conservative states and groups to further restrict abortion access. District Judge Matthew J. Kacsmaryk issued a preliminary injunction suspending the approval of mifepristone on April 7, 2023; on appeal by the government to the Fifth Circuit, the Fifth Circuit partially reverted Kacsmaryk's injunction, allowing the drug's 2000 approval to stand, but putting on hold changes to the FDA's distribution rules on the drug that were put in place in 2016, including distribution by mail. A separate Washington federal district judge also issued on April 7, 2023, a separate injunction forcing the FDA to maintain the distribution of mifepristone in 16 states and the District of Columbia. On April 13, that judge issued another order, purporting to force FDA to maintain approval regardless of the Texas or Fifth Circuit ruling. The Supreme Court of the United States heard the case in March 2024, with the Fifth's modified order stayed until the Supreme Court issues its decision. Background Medication abortion, in which prescription medications are used to induce abortion of the embryo, typically occurs with a mixture of two different drugs—mifepristone and misoprostol. Mifepristone was approved by the Food and Drug Administration (FDA) in September 2000. Medication abortion accounts for over half of all abortions in the United States. Under the 2000 approval, mifepristone was approved by the FDA under Congressional regulations granted to them by Subpart H of the FDA's mandate. This included restricted distribution of mifepristone through hospitals and other medical facilities. With passage of the Food and Drug Administration Amendments Act of 2007, the Federal Food, Drug, and Cosmetic Act was amended to require the use of Risk Evaluation and Mitigation Strategies (REMS) to identify the benefits and risks of any approved drug and give the FDA more control over adjusting their approvals of drugs. By the time the FDA completed the REMS for mifepristone in 2011, it kept the same limits on access at hospitals and other medical facilities. In March 2016, the FDA loosened safety precautions present in the original approval, allowing medical practitioners to also prescribe the drug, and increased the time into the pregnancy term when the drug could be used. In April 2021, in response to the lack of access to medical care caused by the COVID-19 pandemic, the FDA allowed mifepristone to be obtained by mail from certified medical businesses and practitioners, which greatly increased access to the drug. Another REMS change was made in January 2023, allowing pharmacies approved by mifepristone manufacturers to also distribute the drug. In June 2022, the United States Supreme Court decided Dobbs v. Jackson Women's Health Organization, which overruled Roe v. Wade and held that there was no constitutional right to abortion, which enabled states to ban abortion. In order to restrict abortions, several states also passed laws to prevent the sale of mifepristone. Lawsuit Plaintiffs The lead plaintiff, the Alliance for Hippocratic Medicine (AHM), describes itself as "uphold[ing] and promot[ing] the fundamental principles of Hippocratic medicine", which "include protecting the vulnerable at the beginning and end of life." AHM was incorporated in August 2022 and is headquartered in Amarillo, Texas. Other plaintiffs include three out-of-state anti-abortion groups—the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), the American College of Pediatricians, and Christian Medical and Dental Associations—in addition to four doctors. The plaintiffs argued that the FDA did not properly consider all evidence at the time of the 2000 approval of mifepristone, and sought relief by having the court revoke the FDA's approval. The plaintiffs are represented by the Christian legal advocacy group Alliance Defending Freedom (ADF). The ADF drafted the law at issue in Dobbs, Mississippi's Gestational Age Act. Defendants The original defendants are the FDA, Commissioner of Food and Drugs Dr. Robert Califf, Principal Deputy Commissioner Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research Dr. Patrizia Cavazzoni, the Department of Health and Human Services, and HHS Secretary Xavier Becerra. Later on in the lawsuit, Danco Laboratories, the manufacturer of brand-name mifepristone (Mifeprex), intervened in the case. Rulings Texas District Court opinion and order The case was filed in the United States District Court for the Northern District of Texas and heard by Judge Matthew J. Kacsmaryk. Ahead of an in-person hearing on the case, Kacsmaryk delayed entering the hearing on the court docket, citing concerns about potential protests over the hearing. After this information was leaked, the date was posted and the hearing took place as scheduled, on March 15, 2023. On April 7, 2023, Kacsmaryk issued his opinion finding primarily in favor of the plaintiffs, and issued an order granting AHM's preliminary injunction, suspending the FDA's approval of the drug. He first concluded that the plaintiffs have standing to sue—the legal right to bring a case before a judge. He held that because mifepristone can cause serious complications to pregnant women and girls, they might need to go to a doctor for treatment; that abortionists generally do not treat such cases; that the associations bringing the case represented some doctors to whom the injured women and girls might turn; that this would harm the doctors who had to care for those patients; and that that harm to the doctors was "sufficiently imminent" and there was a "'substantial risk' that the harm will occur". As the organizations were doctors' groups, he also ruled that they had organizational standing. Kacsmaryk then ruled that the Administrative Procedure Act's six-year statute of limitations—which would normally have started in 2016, when one of the plaintiff's review petitions was rejected—was "reopened" in 2016 and again in 2021, when the FDA increased access to the drug. He finally ruled that the approval of mifepristone was "otherwise not in accordance with law"—citing the Comstock Act's prohibition on interstate shipment of abortifac.... Discover the Cindy Mallin popular books. Find the top 100 most popular Cindy Mallin books.