{"id":296656,"date":"2023-08-16T17:15:43","date_gmt":"2023-08-16T22:15:43","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=296656"},"modified":"2023-08-20T20:50:52","modified_gmt":"2023-08-21T01:50:52","slug":"court-fda-abortion-pill-safety-supreme","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/court-fda-abortion-pill-safety-supreme\/","title":{"rendered":"Court says FDA must restore abortion pill safety measures, pending Supreme Court review"},"content":{"rendered":"
<\/div>

The U.S. Court of Appeals for the Fifth Circuit ruled on Wednesday to allow the abortion pill mifepristone to remain “available to the public under the conditions for use that existed<\/a> in 2016″ while it vacates more recent expansions of the drug’s approved use under the Food and Drug Administration’s (FDA) safety requirements (REMS). Those expansions removed the in-person dispensing of the abortion pill and enabled<\/a> the drug to be shipped by mail \u2014 and also expanded the use of the pill from seven (7) weeks to 10 weeks.<\/p>\n

In addition, the Court’s abortion pill ruling will allow the “generic version of mifepristone,” which was approved in 2019, to “be available under the same conditions as Mifeprex.”<\/p>\n

However, as Bloomberg<\/a> states, “The decision… won\u2019t have an immediate impact on access to the medication, mifepristone. The pill remains available under an April order<\/a>\u00a0from the US Supreme Court that will stay in effect until the high court rules again on the matter or refuses to hear the case on appeal.”<\/p>\n

Calling the decision a “victory for women\u2019s health,” Alliance Defending Freedom (ADF), which represents the plaintiffs in the case, claimed<\/a> in a press release that the Fifth Circuit\u2019s decision<\/a>\u00a0in\u00a0Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration<\/em><\/a> found that the FDA must restore critical safeguards for chemical abortion drugs.<\/p>\n

\u201cThe 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” ADF\u00a0 Senior Counsel Erin Hawley, vice president of the ADF Center for Life and Regulatory Practice, wrote<\/a> of the Court’s ruling.<\/p>\n

The decision<\/a>, rendered by Judges Jennifer Walker Elrod, James Ho, and Cory Wilson, looked at four actions: the 2000 Approval, the 2016 Amendments, the 2019 Generic Approval, and the 2021 Non-Enforcement Decision. Those actions were “challenged by the Alliance for Hippocratic Medicine<\/a>\u2014an association of doctors who research, teach, and advocate for ethical medical practices\u2014several similar organizations, and several individual doctors,” the document in the Court’s ruling stated.<\/p>\n

“At bottom, the Medical Organizations and Doctors contend that FDA overlooked important safety risks in approving mifepristone and amending its restrictions. They assert that FDA\u2019s actions were unlawful under the Administrative Procedure Act,” the decision<\/a> read in part. “According to the Doctors, when they treat women who are experiencing complications after taking mifepristone, they are required to perform or complete an abortion, or otherwise required to participate in a process that facilitates abortion. They maintain that personally conducting those procedures violates their sincerely held moral beliefs. The Doctors also contend that treatment of mifepristone patients diverts time and resources away from their ordinary patients, causes substantial mental and emotional distress, and exposes them to heightened malpractice risk and increased insurance costs.”<\/p>\n

\u00a0