{"id":256403,"date":"2021-11-09T08:50:31","date_gmt":"2021-11-09T14:50:31","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=256403"},"modified":"2021-12-16T15:28:07","modified_gmt":"2021-12-16T21:28:07","slug":"fda-removes-abortion-pill-safety-protocols-drug","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/fda-removes-abortion-pill-safety-protocols-drug\/","title":{"rendered":"If the FDA removes abortion pill safety protocols, it won’t be because the drug is safe"},"content":{"rendered":"
<\/div>

The original approval process for the abortion pill in the United States two decades ago was highly\u00a0politicized<\/a>, with the Food and Drug Administration (FDA) refusing to even\u00a0publish<\/a>\u00a0the names of the \u201cexperts\u201d who initially reviewed the drug. Today,\u00a0as abortion advocates fear Roe v. Wade<\/em> is in peril, that politicization continues in the form of lawsuits and regulatory decisions to expand the abortion pill.<\/p>\n

Lifting\u00a0FDA’s REMS safety program<\/strong><\/p>\n

The abortion pill is currently under an FDA safety program called the\u00a0Risk Evaluation and Mitigation System<\/a> (REMS), which the\u00a0\u00a0FDA<\/a>\u00a0can require “for certain medications with serious safety concerns<\/a>.\u201d<\/p>\n

Under REMS, mifepristone (brand name Mifeprex) \u2014 one of the two drugs in the abortion pill protocol \u2014 \u201cmust be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.\u201d Teen girls and women may only obtain the abortion pill with\u00a0an in-person visit to a\u00a0certified prescriber<\/em>\u00a0of the drug, who for safety purposes must be capable of properly assessing gestational age and deadly ectopic pregnancies. In addition, the REMS safety regulations\u00a0require<\/a>\u00a0providers to sign the manufacturer\u2019s\u00a0prescriber agreement<\/a>\u00a0and they must stock the drug, since it currently cannot be dispensed in a pharmacy.<\/p>\n

However,\u00a0using the ruse of the COVID-19 pandemic, the Biden-Harris administration\u2019s FDA has\u00a0allowed<\/a>\u00a0the pills to be dispensed online, by approved prescribers, for the duration of the pandemic.<\/p>\n

Chelius v. Becerra\u00a0<\/strong>(originally\u00a0Chelius v Wright<\/a>)<\/p>\n

At the time the abortion pill was first approved<\/a> (2000), the industry believed<\/a> that doctors would be willing to prescribe the regimen \u2014 but they were wrong. In 2001, The\u00a0Washington Post\u00a0wrote<\/a>:<\/p>\n

At one time, the most ambitious argument for RU-486 was that it would move abortion away from clinics (and clinic protesters) and into the offices of more private OB-GYNs and family practitioners. But there have been signs all along that this is not likely: In a survey conducted by the Kaiser Family Foundation, doctors tended to be less willing to administer RU-486 the more they knew about it.<\/em><\/p>\n

Even as late as 2016, abortion pill manufacturer Danco’s director of marketing and public affairs,\u00a0Abigail Long<\/a>, told Forbes that Danco\u2019s representatives regularly encounter physicians who say they simply send their patients to Planned Parenthood.<\/p>\n

Fast forward to 2019, and little had changed when abortionist Daniel Grossman\u00a0told<\/a>\u00a0Ms. Magazine that one reason OB-GYNs did not offer the abortion pill is because they do not want to stock it in their facilities.<\/p>\n

So, in\u00a02017<\/a>, the American Civil Liberties Union (ACLU) filed the Chelius<\/em> case to challenge the REMS on behalf of Hawaiian doctor\u00a0Graham T. Chelius<\/a>, who\u00a0argues<\/a>\u00a0that complying with the REMS requirements to \u201cprocure, stock, and dispense Mifeprex\u201d at his medical facility \u201crather than issuing a prescription, from the privacy of my office\u201d would, in his words, \u201cdisrupt\u201d and \u201cinterfere\u201d with his ability to \u201cserve\u201d his patients.<\/p>\n

“For many health care providers across the country, registering with the drug manufacturer and stocking Mifeprex at their office is difficult or impossible,” the lawsuit<\/a> alleges.\u00a0“Some are deterred by the logistics of being ‘certified’ by a drug manufacturer, entering into a contract with the drug distribution company, and ordering the medication\u2014a process unfamiliar to many clinicians because it is required for such a small number of drugs, and which can be particularly complicated and time-consuming for clinicians at large health care institutions.”<\/p>\n

American College of Obstetricians and Gynecologists (ACOG) v. FDA<\/strong><\/p>\n

As\u00a0previously<\/a>\u00a0mentioned, the abortion industry used the COVID-19 pandemic to lift the REMS and expand access to the abortion pill. Yet,\u00a0well before<\/a>\u00a0the pandemic, the industry had\u00a0expanded<\/a>\u00a0its abortion pill clinical trials and then\u00a0rolled out<\/a>\u00a0a \u201cno test<\/a>\u201d abortion pill protocol, which\u00a0some medical professionals have said<\/a>\u00a0endangers women. Around the same time frame, the ACOG also\u00a0changed<\/a>\u00a0its recommendations to line up exactly with the abortion industry\u2019s attempts to expand access to the abortion pill.<\/p>\n

The ACOG is not an impartial medical organization; it\u00a0is radically\u00a0pro-abortion<\/a>.<\/p>\n

ACOG\u2019s move towards abortion was\u00a0influenced<\/a>\u00a0by population control enthusiasts who eventually\u00a0redefined<\/a>\u00a0the beginning of life. The organization has been\u00a0funded<\/a>\u00a0by\u00a0groups<\/a>\u00a0that directly received\u00a0funds<\/a>\u00a0from U.S. abortion pill manufacturer Danco Laboratories.<\/p>\n

In May 2020, the ACLU\u00a0filed<\/a>\u00a0a lawsuit on behalf of the ACOG to suspend the FDA’s REMS during the COVID-19 pandemic.\u00a0The\u00a0lawsuit<\/a>\u00a0asserted<\/a>\u00a0that allowing the drug to be sold only in an approved clinic or hospital put abortion seekers at risk for the coronavirus. At the time, the FDA under the Trump administration chose to\u00a0stand by<\/a>\u00a0its safety requirements,\u00a0calling<\/a>\u00a0the lawsuit\u2019s assertions about risking patients\u2019 lives \u201cspeculative\u201d at best.<\/p>\n

But in\u00a0July 2020<\/a>, U.S. District Judge\u00a0Theodore D. Chuang placed the in-person safety requirement under a preliminary injunction during the COVID-19 pandemic.\u00a0By\u00a0October that same year<\/a>, based on the order enabling\u00a0pharmacies to stock and subsequently mail abortion pills\u00a0for<\/em>\u00a0a certified prescriber,\u00a0U.S. based online pharmacy\u00a0Honeybee Health<\/a>\u00a0agreed to distribute the drug directly to women by mail for abortion providers who prescribe it.<\/p>\n

A few months later (December 2020),\u00a0Judge Chuang denied<\/a>\u00a0the Trump administration\u2019s\u00a0request<\/a>\u00a0to reinstate the REMS requirements.<\/p>\n

Enter the Biden Administration…<\/p>\n

FDA to review REMS<\/strong><\/p>\n

President Joe Biden promised to promulgate the extreme expansion of abortion under the Biden-Harris Administration. He took office in January of 2021 and placed the FDA under the direction of newly-appointed, radically pro-abortion\u00a0HHS Secretary<\/a>\u00a0Xavier Becerra.<\/p>\n

By February of 2021, Planned Parenthood and its Congressional allies\u00a0sent a letter<\/a>\u00a0to acting commissioner Dr. Janet Woodcock pressuring the FDA to lift the REMS. And the FDA swiftly complied, at least temporarily.\u00a0On April 13, 2021, Woodcock\u00a0issued a letter<\/a>\u00a0to ACOG telling them the agency would continue to\u00a0allow<\/a>\u00a0the distribution of dangerous abortion drugs by mail for the duration of the pandemic.<\/p>\n

Woodcock\u00a0previously<\/a>\u00a0served as Director of the FDA\u2019s Center for Drug Evaluation and Research when the Agency approved the abortion pill.<\/p>\n

In\u00a0May of 2021<\/a>, a motion to stay the Chelius<\/em> case was enacted until December of 2021 when the FDA review of the REMS was expected to be final. Then on November 3, 2021, a status update<\/a>\u00a0was filed, which indicated that the “FDA… anticipates completing its review by December 16, 2021” and the stay on the lawsuit was extended until January 14, 2022 to “give the Parties time to determine appropriate next steps in this litigation.”<\/p>\n

“If FDA\u2019s review of the REMS, and implementation of any changes to the REMS that result from such review, are not completed before the expiration of the\u00a0COVID-19 Public Health Emergency (\u201cPHE\u201d), FDA agrees that it intends to exercise its enforcement discretion with respect to the in-person dispensing requirement of the mifepristone REMS… for a further 30 days following the end of the PHE,” the court document also states.<\/p>\n

The FDA has not indicated exactly who will review the REMS or whether it will rely on studies authored by so-called ‘experts<\/a>‘ often in the pocket of the pill’s manufacturer Danco Laboratories or its generic GenBioPro. And, while we await their review, abortion proponents continue to actively flout the REMS and flood abortion pills into every sector of society \u2014 no matter the safety cost<\/a>.<\/p>\n

\u201cLike\u201d Live Action News on Facebook<\/a>\u00a0for more pro-life news and commentary!<\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

The original approval process for the abortion pill in the United States two decades ago was highly\u00a0politicized, with the Food and Drug Administration (FDA) refusing to even\u00a0publish\u00a0the names of the \u201cexperts\u201d who initially reviewed the drug. Today,\u00a0as abortion advocates fear Roe v. Wade is in peril, that politicization continues in the form of lawsuits and […]<\/p>\n","protected":false},"author":303,"featured_media":186657,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[9953,15],"tags":[575,14009,14010,10195,617,1792,913,10194,14011,14012,5864],"yoast_head":"\nIf the FDA removes abortion pill safety protocols, it won't be because the drug is safe<\/title>\n<meta name=\"description\" content=\"The FDA has not indicated who will review the REMS or whether it will rely on studies authored by 'experts' paid by the pill's manufacturers.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/archive.liveaction.org\/news\/fda-removes-abortion-pill-safety-protocols-drug\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"If the FDA removes abortion pill safety protocols, it won't be because the drug is safe\" \/>\n<meta property=\"og:description\" content=\"The FDA has not indicated who will review the REMS or whether it will rely on studies authored by 'experts' paid by the pill's manufacturers.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/archive.liveaction.org\/news\/fda-removes-abortion-pill-safety-protocols-drug\/\" \/>\n<meta property=\"og:site_name\" content=\"Live Action News\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/liveaction\" \/>\n<meta property=\"article:published_time\" content=\"2021-11-09T14:50:31+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-12-16T21:28:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2018\/08\/abortion-pill-woman-bed.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"650\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Carole Novielli\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@https:\/\/twitter.com\/CaroleNovielli\" \/>\n<meta name=\"twitter:site\" content=\"@liveaction\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Carole Novielli\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/archive.liveaction.org\/news\/fda-removes-abortion-pill-safety-protocols-drug\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/fda-removes-abortion-pill-safety-protocols-drug\/\"},\"author\":{\"name\":\"Carole Novielli\",\"@id\":\"https:\/\/archive.liveaction.org\/news\/#\/schema\/person\/81ff4ca810d98b0b5b376a640452d9e6\"},\"headline\":\"If the FDA removes abortion pill safety protocols, it won’t be because the drug is safe\",\"datePublished\":\"2021-11-09T14:50:31+00:00\",\"dateModified\":\"2021-12-16T21:28:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/fda-removes-abortion-pill-safety-protocols-drug\/\"},\"wordCount\":1224,\"publisher\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/#organization\"},\"keywords\":[\"ACLU\",\"Chelius v. 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