{"id":200513,"date":"2019-04-17T15:13:41","date_gmt":"2019-04-17T20:13:41","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=200513"},"modified":"2021-04-16T19:50:48","modified_gmt":"2021-04-17T00:50:48","slug":"women-die-abortion-pill-fda-generic","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/women-die-abortion-pill-fda-generic\/","title":{"rendered":"As more women die from abortion pill, the FDA approves a generic version"},"content":{"rendered":"
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The FDA has approved a generic version of the abortion pill Mifeprex, at a time when more deaths are being reported and the abortion industry is pushing<\/a>\u00a0for the dangerous abortion inducing chemicals to be dispensed<\/a> online or by mail. According to a notice from the FDA, the generic version is approved for use as an abortifacient. This news comes just a day before the FDA updated<\/a> its adverse effects reports through\u00a02018<\/a>, stating, “As of December 31, 2018, there were reports of 24 deaths<\/strong> of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal…” The FDA’s 2017 report<\/a> put the number of deaths at 22<\/strong>.<\/p>\n

This means that in 2018 alone, two more women died from taking the abortion pill. <\/strong>And yet, now a generic version is going to be made available.<\/p>\n

To date, the report documents nearly\u00a04,200 reported adverse effects, including hospitalization and other serious complications.<\/p>\n

On April 11, 2019, the FDA\u00a0approved GenBioPro, Inc.\u2019s abbreviated new drug application for a generic Mifeprex, which, when used with Misoprostol is approved as an abortion pill regimen. The FDA states<\/a>\u00a0(emphasis added),\u00a0“This approval reflects FDA\u2019s determination that GenBioPro\u2019s product, Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation<\/strong>….”<\/p>\n

READ:\u00a0The secrecy surrounding the abortion pill\u2019s maker and influential financial investors must end<\/a><\/em><\/strong><\/p>\n

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Generic abortion pill by GenBioPro approved by FDA<\/p><\/div>\n

The FDA also states clearly that although they modified the\u00a0Mifeprex application<\/a> to include “mifepristone products,” this change in no way removes the FDA\u2019s REMS<\/em> (Risk Evaluation and Mitigation Strategy<\/a>), \u201ca 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

Of note, on April 11, 2019, FDA approved a supplemental application for Mifeprex, approving modifications to the existing approved REMS for Mifeprex to establish a single, shared system REMS for mifepristone products (including Mifeprex as well as the approved generic version of Mifeprex) for the medical termination of intrauterine pregnancy through 70 days gestation. In establishing the single, shared system REMS, no changes were made to the substantive elements of the REMS<\/strong>. This single, shared system REMS is known as the Mifepristone REMS Program.<\/em><\/p>\n

Find approval information for this 2019 supplement\u00a0here<\/a>.<\/em><\/p>\n

The approved generic version of Mifeprex generally has the same labeling as Mifeprex…Under the law, the approved generic version of Mifeprex is required to use a single, shared system REMS with the brand product, Mifeprex. This single, shared system REMS, known as the Mifepristone REMS Program, sets forth the distribution requirements that must be followed for both Mifeprex and the approved generic version of Mifeprex.<\/em><\/p>\n

Requiring that the generic be subject to FDA’s REMS is good news for now, because, as Live Action News has previously reported<\/a>, the abortion lobby is attempting to expand access to the abortion pills via mail order or pharmacy by pushing \u201cself-managed abortion,\u201d described by\u00a0Guttmacher<\/a><\/u>\u00a0as ending a pregnancy \u201cwithout<\/strong><\/em>\u00a0direct supervision by a health care provider<\/i><\/b>.\u201d To accomplish this, REMS, must be eliminated.<\/p>\n

READ:\u00a0What you should know about the dangerous \u2018self-managed\u2019 abortion pill push<\/a><\/em><\/strong><\/p>\n

Dr. Donna Harrison,\u00a0Executive Director American Association of Pro-Life Obstetricians and Gynecologists(AAPLOG), agreed, telling\u00a0Live Action News (emphasis added):<\/p>\n

Allowing a generic equivalent of Mifeprex basically means that the patent restrictions have run out. So, new drugs have a patent which is time limited… and in the case of Mifeprex, the patent was held by the Population Council<\/strong>. So, now that the patent has run out, generics are allowed. But this does not change the restrictions. REMS are still in place until FDA changes the restrictions. So, just to clarify, this does not mean that Mifeprex is OTC [over-the-counter]. It just changes how much quality control goes in to the pill manufacturing process and how much Danco can charge for the drug.<\/em><\/p>\n

The move towards a generic drug is being hailed a victory by abortion advocates, specifically Dr. Daniel Grossman<\/a>, who has deep ties<\/a> to the “self-managed<\/a>” abortion pill push.<\/p>\n

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FDA Approves generic abortion drug (Image Twitter Dr. Daniel Grossman)<\/p><\/div>\n

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FDA Approves generic abortion drug NWHC (Image: Twitter)<\/p><\/div>\n

Under the Mifepristone REMS Program, the FDA states, “Mifeprex and the approved generic version of Mifeprex” may:<\/p>\n