{"id":30457,"date":"2024-02-29T16:34:35","date_gmt":"2024-02-29T16:34:35","guid":{"rendered":"https:\/\/cincinnatirighttolife.org\/?p=30457"},"modified":"2024-03-01T18:21:51","modified_gmt":"2024-03-01T18:21:51","slug":"plaintiffs-in-supreme-court-abortion-pill-case-say-fda-is-jeopardizing-womens-health","status":"publish","type":"post","link":"https:\/\/cincinnatirighttolife.org\/plaintiffs-in-supreme-court-abortion-pill-case-say-fda-is-jeopardizing-womens-health\/","title":{"rendered":"Plaintiffs in Supreme Court abortion pill case say FDA is ‘jeopardizing women’s health’"},"content":{"rendered":"\n

By Carole Novielli, originally published in LiveAction on February 26, 2024<\/a><\/em><\/strong><\/p>\n\n\n\n

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 \u201cunfettered power.\u201d 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\n\n\n

The brief<\/a>, filed in Alliance for Hippocratic Medicine (AHM) v. Food and Drug Administration (FDA)<\/em> claimed that the \u201cFDA\u2019s removal of safeguards for abortion drugs was arbitrary, capricious, an abuse of discretion, and otherwise unlawful,\u201d the pro-life doctors and medical organizations claimed in their brief.<\/p>\n\n\n\n

\u201cFDA\u2019s precipitous decision to remove its \u2018longstanding, minimally burdensome\u2019 in-office visit\u2026was a textbook violation of the APA [Administrative Procedure Act],\u201d AHM wrote.<\/p>\n\n\n\n

History of Abortion Pill Approval and Conflicts<\/strong><\/h2>\n\n\n\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\u2019s REMS safety requirements in 2016 and 2021.<\/p>\n\n\n\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\n\n\n

In 2021, the Biden FDA eliminated the in-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 allow retail pharmacies to dispense the drug<\/a>.<\/p>\n\n\n\n

Live Action News previously<\/a> documented potential conflicts of interest<\/a> and an incestuous funding trail<\/a> from the investors in U.S. abortion pill manufacturers Danco Laboratories and GenBioPro<\/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\n\n\n

In some instances, these studies have problematically been\u00a0authored<\/a>\u00a0by\u00a0people on the\u00a0payroll<\/a>\u00a0of the abortion pill\u2019s manufacturers<\/em>.<\/p>\n\n\n\n

2016 and 2021 FDA changes<\/strong><\/h2>\n\n\n\n

In 2016, the FDA chose to \u201celiminate the requirement that prescribers report all serious adverse events,\u201d AHM claimed, adding that \u201cfor 2016, FDA failed to consider a major aspect of the problem: \u2018the cumulative effect\u2019 of the interrelated changes.\u201d<\/p>\n\n\n\n

AHM added, \u201cThe agency, instead, noted that abortion-drug manufacturers \u2018report adverse events, including serious adverse events, to FDA\u2019\u2026 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,.\u201d<\/p>\n\n\n\n

The FDA\u2019s 2016 changes, according to AHM, \u201cincreased the risk that more women taking abortion drugs will need emergency care\u201d in three ways:<\/p>\n\n\n\n