{"id":277292,"date":"2022-10-07T06:44:51","date_gmt":"2022-10-07T11:44:51","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=277292"},"modified":"2022-10-05T23:00:37","modified_gmt":"2022-10-06T04:00:37","slug":"abortion-industry-schemes-expand-fda-pill","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/abortion-industry-schemes-expand-fda-pill\/","title":{"rendered":"Abortion industry’s latest scheme: Get the FDA to approve the abortion pill for ‘miscarriage management’"},"content":{"rendered":"
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A petition<\/a>\u00a0from 48 pro-abortion groups is asking the U.S. Food and Drug Administration (FDA) to approve the abortion pill (mifepristone) for miscarriage care \u2014 a move that is essentially a\u00a0scheme to get the drug approved under “other indications” and circumvent laws that restrict abortion. In addition, the petition is using the ruse to\u00a0convince the FDA to remove mifepristone from an important safety system known as the\u00a0Risk Evaluation and Mitigation System<\/a>\u00a0(REMS).<\/p>\n

The\u00a0letter<\/a>\u00a0was\u00a0signed by the pro-abortion American College of Obstetricians and Gynecologists\u00a0(ACOG)<\/a>, the American Humanist Association, American Medical Association (AMA), Expanding Medication Abortion Access (EMAA) Project, NARAL Pro-Choice America, the National Abortion Federation (NAF), Physicians for Reproductive Health (PRH), Planned Parenthood Federation of America (PPFA), and UCSF Bixby Center for Global Reproductive Health, among others who\u00a0could likely benefit financially from the move.\u00a0It read in part:<\/p>\n

The American College of Obstetricians and Gynecologists submits this petition on behalf of itself and 48 other organizations listed…request that the Food & Drug Administration (FDA) ask Danco Laboratories, LLC… the holder of the approved new drug application for Mifeprex (mifepristone)\u2014to submit a Supplemental New Drug Application (sNDA) that seeks to add miscarriage management as an indication to the drug\u2019s label and to eliminate or modify mifepristone\u2019s Risk Evaluation and Mitigation Strategy (REMS) so that it is not unduly burdensome for that use. <\/em><\/p>\n

In the meantime, Petitioners also request that FDA immediately exercise enforcement discretion with respect to the use and distribution of mifepristone for miscarriage management without complying with the REMS.<\/em><\/p>\n

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The letter also claims that “clinicians who treat miscarriage and their patients have an urgent need to address increasing barriers to accessing mifepristone.”<\/p>\n

Since when? Doctors have been treating miscarriage since well before mifepristone was introduced.<\/p>\n

The REMS<\/strong><\/p>\n

The abortion advocates then “urge both FDA and Danco to act expeditiously” and “request that FDA immediately announce that it will exercise enforcement discretion to permit the use and distribution of mifepristone consistent with the requested miscarriage indication and changes in the REMS for this indication.”<\/p>\n

The REMS limits prescribers to only those approved by Danco or the generic manufacturer GenBioPro<\/a> \u2014 but\u00a0removing the REMS for miscarriage care would open access to the abortion pill to anyone and expand abortion in the process.<\/p>\n

The FDA approved<\/a> the drug mifepristone (which starves the preborn child of nutrients) as the abortion pill in 2000, in a regimen along with a second drug, misoprostol (which causes contractions to expel the baby). It was later placed<\/a> under\u00a0an FDA safety system known as REMS, after multiple deaths prompted a closer watch of the drug.<\/p>\n