{"id":190240,"date":"2018-10-29T04:49:20","date_gmt":"2018-10-29T09:49:20","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=190240"},"modified":"2022-04-21T07:23:23","modified_gmt":"2022-04-21T12:23:23","slug":"fda-abortion-pill-medical-supervision","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/fda-abortion-pill-medical-supervision\/","title":{"rendered":"Abortion groups want FDA to allow abortion pill use without medical supervision"},"content":{"rendered":"
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The abortion lobby is planning to expand abortion access by seeking to change the FDA’s safety strategy for dispensing the abortion pill regimen known as RU486.\u00a0<\/span>Planned Parenthood and the abortion industry\u00a0present<\/a>\u00a0abortion as \u201csafe and simple,\u201d but one look at\u00a0forms<\/a>\u00a0they require women to sign reveals the real truth. Missed abortion, blood clots, infection and even death are among the risks associated with medication abortion.\u00a0Despite these risks, the abortion lobby is pushing for\u00a0“<\/b>home use,<\/b><\/a>” “<\/b>mail order,<\/b><\/a>” OTC, and “telabortion<\/u><\/span><\/span>.”<\/a><\/p>\n

The abortion pill regimen is made up of two drugs: Misoprostol and Mifeprex, which is currently regulated by the FDA<\/a> under a system<\/a> known as REMS,<\/a>\u00a0an acronym that stands for Risk Evaluation and Mitigation Strategies<\/em>. According to the FDA<\/a>, “REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”<\/p>\n

The\u00a0REMS<\/a>\u00a0document states that, “Mifeprex must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.” The pill’s manufacturer,\u00a0Danco Laboratories, must “[e]nsure that Mifeprex is not distributed to or dispensed through retail pharmacies or other settings….”<\/p>\n

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RU486 abortion pill Mifeprex (Image credit: Danco)<\/p><\/div>\n

Prescribers of Mifeprex must<\/a> be able to “assess the duration of pregnancy accurately,” “diagnose ectopic pregnancies,” and “provide surgical intervention in cases of incomplete abortion or severe bleeding.”<\/p>\n

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Prescriber agreement of abortion pill under REMS, (Image credit FDA)<\/p><\/div>\n

There have been 22 reported\u00a0deaths<\/a> associated with the abortion pill, and thousands of hospitalizations.\u00a0If REMS is lifted, additional women may face serious complications due to a failure to properly detect gestational age or an ectopic pregnancy.<\/p>\n

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RU486 abortion pill serious adverse effects, updated 2017<\/p><\/div>\n

Under the current\u00a0REMS agreement<\/a>, prescribers must report deaths to Danco, which must then report<\/a> to the FDA.\u00a0But, if REMS is eliminated, those reports may also disappear.<\/p>\n

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REMS requires DANCO to report abortion pill deaths (Image credit: Prescriber Agreement, DANCO)<\/p><\/div>\n

Despite the risks, abortion promoters are currently recruiting for a study<\/a>\u00a0in which women will obtain the abortion pill regimen from a pharmacy instead of in an abortion facility. Gynuity<\/a> is conducting<\/a>\u00a0these clinical trials for the \u201cFeasibility of Medical Abortion by Direct-to-Consumer Telemedicine<\/a>,\u201d or \u201cmail order<\/a>\u201d abortion pills at select locations, including Planned Parenthood. The website<\/a>, TelAbortion<\/i>, has even been created to recruit for this experiment.<\/p>\n

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Telabortion website<\/p><\/div>\n

While pro-life groups are investigating ways to stop home use<\/a> abortion, the abortion industry’s call to lift REMS is growing louder.<\/p>\n

Tara Health Foundation<\/a>, an organization<\/a> which recently\u00a0pledged <\/a>to fund the failed push for the abortion pill on college campuses in California, published\u00a0a 92-page\u00a0strategy<\/a>\u00a0on its website which includes the push for\u00a0\u201chome use<\/a>\u201d abortions along with the elimination of REMS.<\/p>\n

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TARA Health Foundation seeks to eliminate REMS for abortion pills (Image credit: Reproductive Health Investors Alliance report)<\/p><\/div>\n

Live Action News has previously<\/a> reported that Planned Parenthood’s\u00a02019 plan<\/a>\u00a0<\/b>states, “Planned Parenthood will also be expanding its telemedicine services to increase access to medication abortion for patients living in remote communities.”<\/p>\n

A consortium of abortion organizations — Advancing New Standards in Reproductive Health (ANSIRH), Gynuity Health Projects, and Ibis Reproductive Health — published a report<\/a>\u00a0entitled, “A roadmap for research on self-managed abortion in the United States.” The report suggested,\u00a0“<\/b>[M]edication abortion could be even further demedicalized through pharmacy dispensing and expansion of telemedicine models\u2014or even making it available over the counter (OTC)\u2014which have the potential to expand access greatly.”<\/p>\n

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Report: Roadmap for research on self managed abortion<\/p><\/div>\n

They add, “A number of critical research projects to advance this effort are underway, and include studies of: inperson pharmacy dispensing of mifepristone, clinician-to-clinic telemedicine, direct-to-patient telemedicine, an assessment of demand for and interest in advance provision of medication abortion pills, and the pilot of a label comprehension study for an OTC mifepristone-misoprostol product. Additional research is needed to document the safety, acceptability, and feasibility of a range of direct-to-patient telemedicine innovations<\/b>.”<\/p>\n

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Roadmap for self managed abortion<\/p><\/div>\n

A report<\/a> which seems to soft-pedal these “self-managed abortions<\/a>,” published\u00a0by Guttmacher, reads in part:<\/p>\n