{"id":272748,"date":"2022-07-21T12:39:46","date_gmt":"2022-07-21T17:39:46","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=272748"},"modified":"2022-07-21T12:53:49","modified_gmt":"2022-07-21T17:53:49","slug":"biden-administration-forcing-pharmacies-dispense-abortion-pill-fda-rules","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/biden-administration-forcing-pharmacies-dispense-abortion-pill-fda-rules\/","title":{"rendered":"Is the Biden administration forcing pharmacies to dispense the abortion pill against FDA rules?"},"content":{"rendered":"
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The Biden Administration recently sent out a letter<\/a> essentially\u00a0threatening<\/a> pharmacies who “refuse” to fill prescriptions for mifepristone, the currently approved abortion pill. The Administration claims that if pharmacies do not fill these prescriptions, the “pharmacy may be discriminating on the basis of sex.” However, the problem is that under the Food and Drug Administration (FDA) safety system called REMS,\u00a0only approved prescribers<\/em> can dispense the drug.<\/p>\n

The abortion pill (Mifeprex or mifepristone) was approved<\/a> in 2000 in a regimen with the drug misoprostol (which was not initially\u00a0approved<\/a> for use in pregnancy). Shortly after its approval, mifepristone was placed under a safety system called REMS, which has strict rules for who and how the drug can be dispensed.<\/p>\n

Mifepristone was approved for abortion, not miscarriage care<\/strong><\/p>\n

The Office for Civil Rights letter to pharmacists lays out a scenario in which “[a]n individual experiences an early pregnancy loss (first-trimester miscarriage) and their health care provider prescribes pretreatment with mifepristone followed by treatment with misoprostol to assist with the passing of the miscarriage.”\u00a0While doctors can use drugs off-label, the abortion drug mifepristone has never been approved by the FDA for miscarriage care<\/strong><\/em>.<\/p>\n

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Biden’s Office of Civil Rights threatens Pharmacists over Mifepristone dispensing<\/p><\/div>\n

Live Action News has previously\u00a0explained<\/a>\u00a0how a\u00a0natural miscarriage<\/a>\u00a0is\u00a0not<\/em>\u00a0the same as an induced abortion, yet the abortion industry has been seeking<\/a> to blur the line between the two, conflating natural \u201cpregnancy loss\u201d with the intentional ending of a preborn child\u2019s life via the abortion pill and \u201cself-managed\u201d abortion.\u00a0In fact, abortion insiders have admitted<\/a> that sneaking in abortion drugs under “other indications” was a strategic method of guaranteeing the drugs remain on the shelves and are never pulled.<\/p>\n

According to the FDA’s most current label<\/a>, mifepristone or Mifeprex is “a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.” In addition, the FDA website<\/a> is clear that “Mifeprex (mifepristone) is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifeprex or its approved generic<\/a> Mifepristone Tablets, 200 mg, when used together with another medicine called misoprostol, is used to end an early pregnancy (70 days or less since the first day of the last menstrual period).”<\/p>\n

Mifepristone is monitored under REMS safety requirements<\/strong><\/p>\n

REMS is an acronym which stands for\u00a0Risk Evaluation and Mitigation Strategy. Live Action News has\u00a0previously<\/a>\u00a0detailed the FDA’s concern over the safety of the abortion pill in past years. This is why in\u00a0April 2011, the FDA\u00a0determined<\/a>\u00a0that the\u00a0REMS<\/a>\u00a0safety requirement was\u00a0necessary<\/em>\u00a0for mifepristone.\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

You must be approved to dispense mifepristone<\/strong><\/p>\n

Under REMS<\/a>, mifepristone can only be distributed by an approved clinic, health care provider, or hospital \u2014 and to be approved you must submit<\/a> a prescriber agreement to the drug’s manufacturer, Danco Laboratories. In December of 2021, the FDA weakened<\/a>\u00a0these REMS and allowed pharmacies to ship<\/em> the abortion pill via mail. Prior to that decision, the FDA\u2019s REMS prohibited the abortion pill from being dispensed online or in pharmacies and required the pill to be dispensed\u00a0in person<\/em>\u00a0in approved clinics or hospitals that could properly date a woman\u2019s pregnancy, rule out deadly ectopic pregnancies, and offer or refer for emergency care in cases of complications or when\u00a0abortion pill failures<\/a>\u00a0result in incomplete abortions.<\/p>\n

According to the FDA<\/a>, \u201cIn 2021, FDA undertook a full review of the Mifepristone REMS Program. Based on that review, FDA has determined that the REMS will include the following elements:<\/p>\n