{"id":259084,"date":"2021-12-16T17:04:27","date_gmt":"2021-12-16T23:04:27","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=259084"},"modified":"2021-12-17T15:09:27","modified_gmt":"2021-12-17T21:09:27","slug":"fda-permanently-loosens-abortion-pill-safety-measure","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/fda-permanently-loosens-abortion-pill-safety-measure\/","title":{"rendered":"BREAKING: FDA permanently loosens abortion pill safety measures to allow pills by mail"},"content":{"rendered":"
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The abortion pill can now be sold online and through the mail following a December 2021 modification of the Food and Drug Administration (FDA)’s safety requirements under the\u00a0Risk Evaluation and Mitigation System<\/a>\u00a0(REMS).\u00a0A limited number of drugs on the market have been placed under these safety requirements, which the\u00a0FDA<\/a>\u00a0can put in place \u201cfor certain medications with\u00a0serious safety concerns<\/a>.\u201d<\/p>\n

The abortion pill known as mifepristone (brand name Mifeprex) was originally<\/a> placed under the REMS<\/a>\u00a0in\u00a0April 2011<\/a>, due to several adverse events reports, including deaths.<\/p>\n

Prior to today, the FDA’s REMS prohibited the abortion pill from being dispensed online or in pharmacies and required the pill to be dispensed in person<\/em> in approved clinics or hospitals that could properly date a woman’s pregnancy, rule out deadly ectopic pregnancies, and offer or refer for emergency care in cases of complications or when abortion pill failures<\/a> result in incomplete abortions.<\/p>\n

This in-person requirement, however, had been placed under a preliminary injunction in\u00a0July 2020<\/a>\u00a0by U.S. District Judge\u00a0Theodore D. Chuang, for the duration of the COVID-19 pandemic. Then in\u00a0April of 2021<\/a>, the Biden Administration\u2019s FDA temporarily enabled abortion pill distribution by mail during the\u00a0COVID-19 pandemic<\/a>.<\/p>\n

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FDA REMS allows abortion pill by mail as of December 16 2021<\/p><\/div>\n

The modification was posted on\u00a0December 16, 2021<\/a>\u00a0to the FDA’s website:<\/p>\n

After conducting a review of the single, shared system Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, known as the Mifepristone REMS Program, FDA determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.<\/em><\/p>\n

According to the FDA, the modifications to the Mifepristone REMS Program will consist of:<\/em><\/p><\/blockquote>\n

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  • \n

    Removing the requirement that mifepristone be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals (referred to as the \u201cin-person dispensing requirement\u201d)<\/em><\/p><\/blockquote>\n<\/li>\n

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    Adding a requirement that pharmacies that dispense the drug be certified<\/em><\/p><\/blockquote>\n<\/li>\n<\/ul>\n

    FDA also wrote, “…[r]emoving the in-person dispensing requirement will allow, for example, dispensing of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals as currently outlined in the Mifepristone REMS Program. Applicants began using a mail order distribution model when the in-person dispensing requirement was not being enforced during the COVID-19 public health emergency (PHE); this distribution model remains in use today.”<\/p>\n

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    BREAKING<\/p>\n

    Despite the abortion pill killing 24 mothers and 3,700,000 children,<\/p>\n

    The Biden FDA just permanently removed in-clinic dispensing requirements for abortion pills, allowing the deadly drugs to be sent by mail, prescribed by "doctors," & fulfilled by pharmacies<\/p>\n

    Horrific<\/p>\n

    — Lila Rose (@LilaGraceRose) December 16, 2021<\/a><\/p><\/blockquote>\n