{"id":307575,"date":"2024-02-26T11:32:25","date_gmt":"2024-02-26T17:32:25","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=307575"},"modified":"2024-02-25T18:53:02","modified_gmt":"2024-02-26T00:53:02","slug":"plaintiffs-supreme-court-abortion-pill-fda-jeopardizing","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/plaintiffs-supreme-court-abortion-pill-fda-jeopardizing\/","title":{"rendered":"Plaintiffs in Supreme Court abortion pill case say FDA is ‘jeopardizing women’s health’"},"content":{"rendered":"
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A group of pro-life doctors who are plaintiffs in an upcoming U.S. Supreme Court abortion pill case have filed their brief seeking to hold the Food and Drug Administration (FDA) accountable against an alleged “unfettered power.” The plaintiffs believe the FDA failed to protect women when they moved to expand use of the approved abortion drug, mifepristone. The case is set to be heard on March 26, 2024.<\/p>\n

The brief<\/a>, filed in Alliance for Hippocratic Medicine (AHM) v. Food and Drug Administration (FDA)<\/em> claimed that the “FDA\u2019s removal of safeguards for abortion drugs was arbitrary, capricious, an abuse of discretion, and otherwise unlawful,” the pro-life doctors and medical organizations claimed in their brief.<\/p>\n

“FDA\u2019s precipitous decision to remove its ‘longstanding, minimally burdensome’ in-office visit…was a textbook violation of the APA [Administrative Procedure Act],” AHM wrote.<\/p>\n

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Pro-life doctors in the AHM v FDA abortion pill case speak to ADF attorneys (Image via ADF)<\/p><\/div>\n

History of Abortion Pill Approval and Conflicts<\/strong><\/p>\n

AHM originally sought to question the legitimacy of the 2000 approval of the abortion pill by the FDA. However, due to previous decisions<\/a> in the case, arguments before the High Court will center around changes made by the FDA to the drug’s REMS safety requirements in 2016 and 2021.<\/p>\n

Mifepristone was approved<\/a> by the FDA in 2000 to be prescribed in-person through the 7th week of pregnancy. In 2016<\/a>, the FDA removed requirements<\/a> that all non-fatal adverse events be reported. It also allowed the pill to be prescribed through the 10th week of pregnancy, removed the requirement that only physicians prescribe the drug, and no longer required women to take the first pill at the abortion facility.<\/p>\n

In 2021, the Biden FDA eliminated the\u00a0in-person dispensing requirement<\/a> and allowed for the abortion pill to be permanently shipped by mail<\/a>. Then in 2023, the FDA further expanded access to\u00a0allow retail pharmacies to dispense the drug<\/a>.<\/p>\n

Live Action News previously<\/a>\u00a0documented potential\u00a0conflicts of interest<\/a>\u00a0and an\u00a0incestuous funding trail<\/a>\u00a0from the investors in U.S. abortion pill manufacturers Danco Laboratories and\u00a0GenBioPro<\/a>, whose own dollars have been funneled to various groups behind clinical trials and studies of the abortion pill, which claim it is both safe and effective.<\/p>\n

In some instances, these studies have problematically been authored<\/a>\u00a0by\u00a0people on the\u00a0payroll<\/a>\u00a0of the abortion pill\u2019s manufacturers<\/em>.<\/p>\n

2016 and 2021 FDA changes<\/strong><\/p>\n

In 2016, the FDA chose to “eliminate the requirement that prescribers report all serious adverse events,” AHM claimed, adding that “for 2016, FDA failed to consider a major aspect of the problem: ‘the cumulative effect’ of the interrelated changes.”<\/p>\n

AHM added, “The agency, instead, noted that abortion-drug manufacturers ‘report adverse events, including serious adverse events, to FDA’… But FDA did not explain how these far-removed manufacturers would learn about adverse events from OB\/GYNs, hospitalists, and emergency-room doctors who are under no obligation to report,.”<\/p>\n

The FDA’s 2016 changes, according to AHM, “increased the risk that more women taking abortion drugs will need emergency care” in three ways:<\/p>\n