{"id":223651,"date":"2020-05-18T19:35:16","date_gmt":"2020-05-19T00:35:16","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=223651"},"modified":"2020-05-18T17:37:53","modified_gmt":"2020-05-18T22:37:53","slug":"new-york-times-abortion-pill-mail-fda","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/new-york-times-abortion-pill-mail-fda\/","title":{"rendered":"New York Times writer advocates for abortion pill by mail, flouting FDA safety regulations"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p>A recent New York Times <a href=\"https:\/\/www.nytimes.com\/2020\/05\/12\/opinion\/covid-abortion-pill.html\" target=\"_blank\" rel=\"noopener\">opinion piece<\/a> suggests abortionists should dispense the abortion pill through the mail, in violation of the Food and Drug Administration\u2019s Risk Evaluation Mitigation Strategy (REMS).<\/p>\n<p>The Times piece quotes extensively from the co-founders of abortion advocacy group Plan C, which publishes a &#8220;<a href=\"https:\/\/plancpills.org\/reportcard\">report card<\/a>&#8221; encouraging women to get abortion pills from foreign websites like Aid Access, which sell them illegally. Several of these websites\u00a0have <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/aidaccessorg-575658-03082019\">received<\/a>\u00a0FDA <a href=\"https:\/\/archive.liveaction.org\/news\/fda-vaping-products-illegal-abortion-pill\/\" target=\"_blank\" rel=\"noopener\">warning letters<\/a>\u00a0or <a href=\"https:\/\/www.fda.gov\/consumers\/rebel-ltd-abortion-onlinecom-abortionrxcom-and-more\" target=\"_blank\" rel=\"noopener\">abuse complaints<\/a>.\u00a0The FDA specifically warns women against purchasing abortion pills online for safety reasons.<\/p>\n<p>Plan C\u00a0encourages doctors to &#8220;take the first step for mailing mifepristone: registering with\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/secrecy-abortion-pill-maker-investors\/\" target=\"_blank\" rel=\"noopener\">Danco Laboratories<\/a>\u00a0or\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/women-die-abortion-pill-fda-generic\/\" target=\"_blank\" rel=\"noopener\">GenBioPro<\/a>, the only F.D.A.-approved manufacturers.&#8221;<\/p>\n<div id=\"attachment_190302\" style=\"width: 720px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-190302\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-190302 size-full\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2018\/10\/FDA-warns-onsumers-to-not-buy-abortion-pills-over-the-internet.jpg\" alt=\"Image: FDA warns consumers to not buy abortion pills over the internet (Image: FDA)\" width=\"710\" height=\"239\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2018\/10\/FDA-warns-onsumers-to-not-buy-abortion-pills-over-the-internet.jpg 710w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2018\/10\/FDA-warns-onsumers-to-not-buy-abortion-pills-over-the-internet-300x101.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2018\/10\/FDA-warns-onsumers-to-not-buy-abortion-pills-over-the-internet-700x236.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2018\/10\/FDA-warns-onsumers-to-not-buy-abortion-pills-over-the-internet-500x168.jpg 500w\" sizes=\"(max-width: 710px) 100vw, 710px\" \/><p id=\"caption-attachment-190302\" class=\"wp-caption-text\">FDA warns consumers to not buy the abortion pill over the internet (Image: FDA)<\/p><\/div>\n<p>Also quoted in the piece is <a href=\"https:\/\/archive.liveaction.org\/news\/media-abortion-pill-reversal-questionable-study\/\">Dr. Mitchell Creinin<\/a>, who is\u00a0simply described as a &#8220;veteran medical researcher&#8221; from the University of California, Davis. \u201cI strongly believe that the R.E.M.S. does not limit the ability to send mifepristone by mail. It says you have to dispense the drug to the patient in the clinic. But the act of distribution \u2014 by mail, by overnight delivery, whatever \u2014 is different than dispensing,\u201d Creinin states.<\/p>\n<div id=\"attachment_223682\" style=\"width: 561px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-223682\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-223682 \" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/Patrick-Adams-cites-Mitchell-Creinin-who-is-funded-by-abortion-pill-mfg-in-NYTs-article-Image-Twitter.jpg\" alt=\"Image: Patrick Adams cites Mitchell Creinin who is funded by abortion pill mfg in NYTs article (Image: Twitter)\" width=\"551\" height=\"526\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/Patrick-Adams-cites-Mitchell-Creinin-who-is-funded-by-abortion-pill-mfg-in-NYTs-article-Image-Twitter.jpg 660w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/Patrick-Adams-cites-Mitchell-Creinin-who-is-funded-by-abortion-pill-mfg-in-NYTs-article-Image-Twitter-300x287.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/Patrick-Adams-cites-Mitchell-Creinin-who-is-funded-by-abortion-pill-mfg-in-NYTs-article-Image-Twitter-500x478.jpg 500w\" sizes=\"(max-width: 551px) 100vw, 551px\" \/><p id=\"caption-attachment-223682\" class=\"wp-caption-text\">Patrick Adams cites Mitchell Creinin who is funded by abortion pill mfg Danco in NYTs article (Image: Twitter)<\/p><\/div>\n<p>Though the New York Times states that Creinin is unaffiliated with Plan C, the outlet neglects to mention that he is affiliated with Danco Laboratories, the manufacturer of the abortion pill. Live Action News previously\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/media-abortion-pill-reversal-questionable-study\/\" target=\"_blank\" rel=\"noopener\">reported<\/a>\u00a0Creinin\u2019s <a href=\"https:\/\/archive.liveaction.org\/news\/media-ignores-profit-abortion-pill-reversal-researcher\/\">multiple<\/a> conflicts of interest where abortion pill expansions are concerned:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3711556\/pdf\/nihms436531.pdf\">Creinin<\/a> is a Danco\u00a0<a href=\"https:\/\/cloudfront.escholarship.org\/dist\/prd\/content\/qt0v4749ss\/qt0v4749ss.pdf\" target=\"_blank\" rel=\"noopener\">consultant<\/a>.<\/li>\n<li>Creinin\u00a0<a href=\"https:\/\/escholarship.org\/content\/qt0fg6r1bp\/qt0fg6r1bp.pdf\" target=\"_blank\" rel=\"noopener\">receives<\/a>\u00a0<a href=\"https:\/\/web.archive.org\/web\/20110103193458\/https:\/\/www.arhp.org\/uploadDocs\/ARHP_RH10_Program_FINAL.pdf\" target=\"_blank\" rel=\"noopener\">consulting fees<\/a>\u00a0from Danco.<\/li>\n<li>Creinin receives an\u00a0<a href=\"http:\/\/www.ajog.org\/article\/S0002-9378(10)02472-5\/abstract\">honorarium<\/a>\u00a0from\u00a0Danco.<\/li>\n<li>Creinin provides\u00a0\u201cthird-party telephone consults\u201d for Danco.<\/li>\n<\/ul>\n<p>See screenshots below:<\/p>\n<div id=\"attachment_215194\" style=\"width: 491px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-215194\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-215194 size-full\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/12\/Mitchell-D-Creinin-financial-conflicts-from-Danco-abortion-pill-MFG.jpg\" alt=\"Image: Mitchell D Creinin financial conflicts from Danco abortion pill MFG APR Study\" width=\"481\" height=\"543\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/12\/Mitchell-D-Creinin-financial-conflicts-from-Danco-abortion-pill-MFG.jpg 481w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/12\/Mitchell-D-Creinin-financial-conflicts-from-Danco-abortion-pill-MFG-266x300.jpg 266w\" sizes=\"(max-width: 481px) 100vw, 481px\" \/><p id=\"caption-attachment-215194\" class=\"wp-caption-text\">Mitchell D Creinin financial conflicts from Danco abortion pill MFG APR Study<\/p><\/div>\n<div id=\"attachment_200651\" style=\"width: 708px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-200651\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-200651 size-full\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/04\/Mitchell-Creinin-consultant-for-Danco-abortion-pil-MFG.jpg\" alt=\"Image: Mitchell Creinin consultant for Danco abortion pill MFG\" width=\"698\" height=\"297\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/04\/Mitchell-Creinin-consultant-for-Danco-abortion-pil-MFG.jpg 698w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/04\/Mitchell-Creinin-consultant-for-Danco-abortion-pil-MFG-300x128.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/04\/Mitchell-Creinin-consultant-for-Danco-abortion-pil-MFG-500x213.jpg 500w\" sizes=\"(max-width: 698px) 100vw, 698px\" \/><p id=\"caption-attachment-200651\" class=\"wp-caption-text\">Mitchell Creinin consultant for Danco abortion pill MFG<\/p><\/div>\n<div id=\"attachment_200650\" style=\"width: 705px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-200650\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-200650 size-full\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/04\/Mitchell-Creinin-third-party-consults-for-Danco-abortion-pil-MFG.jpg\" alt=\"Image: Mitchell Creinin third party consults for Danco abortion pill MFG\" width=\"695\" height=\"529\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/04\/Mitchell-Creinin-third-party-consults-for-Danco-abortion-pil-MFG.jpg 695w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/04\/Mitchell-Creinin-third-party-consults-for-Danco-abortion-pil-MFG-300x228.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2019\/04\/Mitchell-Creinin-third-party-consults-for-Danco-abortion-pil-MFG-500x381.jpg 500w\" sizes=\"(max-width: 695px) 100vw, 695px\" \/><p id=\"caption-attachment-200650\" class=\"wp-caption-text\">Mitchell Creinin third party consults for Danco abortion pill MFG<\/p><\/div>\n<p>The <a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifeprex\" target=\"_blank\" rel=\"noopener\">FDA<\/a>\u00a0notes (emphasis added):<\/p>\n<p style=\"padding-left: 30px;\"><em>When the [FDA] reviewed and approved the original new drug application for Mifeprex in 2000, it concluded that certain distribution restrictions were necessary to ensure the safe use of that drug. These restrictions were converted to a risk evaluation and mitigation strategy (REMS) in 2011. <\/em><\/p>\n<p style=\"padding-left: 30px;\"><em>In 2016, after reviewing the additional data and information submitted by the sponsor of Mifeprex, and after taking into consideration the safety data that had become available since the initial approval of Mifeprex, the FDA concluded that <strong>certain restrictions continue to be necessary<\/strong> to ensure the safe use of Mifeprex.<\/em><\/p>\n<p>The <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/rems\/index.cfm?event=RemsDetails.page&amp;REMS=390\" target=\"_blank\" rel=\"noopener\">full REMS document<\/a>, updated in April of 2019, <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/rems\/Mifepristone_2019_04_11_REMS_Full.pdf\" target=\"_blank\" rel=\"noopener\">states<\/a>\u00a0clearly that mifepristone must \u201c&#8230; only [be] dispensed <em><strong>in certain healthcare settings<\/strong><\/em> by or under the supervision of a certified prescriber,\u201d and adds that the sponsor (Danco) must \u201cde-certify healthcare providers who do not maintain compliance with certification requirements.\u201d (emphasis added)<\/p>\n<div id=\"attachment_223666\" style=\"width: 713px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-223666\" decoding=\"async\" loading=\"lazy\" class=\" wp-image-223666\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-REMS-for-abortion-pill-Mifepristone-excerpt.jpg\" alt=\"Image: FDA REMS for abortion pill Mifepristone excerpt\" width=\"703\" height=\"615\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-REMS-for-abortion-pill-Mifepristone-excerpt.jpg 843w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-REMS-for-abortion-pill-Mifepristone-excerpt-300x263.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-REMS-for-abortion-pill-Mifepristone-excerpt-768x672.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-REMS-for-abortion-pill-Mifepristone-excerpt-700x613.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-REMS-for-abortion-pill-Mifepristone-excerpt-500x438.jpg 500w\" sizes=\"(max-width: 703px) 100vw, 703px\" \/><p id=\"caption-attachment-223666\" class=\"wp-caption-text\">FDA REMS for abortion pill Mifepristone excerpt<\/p><\/div>\n<p>Plan C\u00a0<a href=\"https:\/\/plancpills.org\/about\">was founded<\/a> in 2015 by Elisa Wells and Francine Coeytaux, and is a fiscal sponsor of the <a href=\"http:\/\/nwhn.org\/\" target=\"_blank\" rel=\"noopener\">National Women\u2019s Health Network<\/a>, which is heavily <a href=\"https:\/\/www.grantmakers.io\/profiles\/v0\/131684331-ford-foundation\/?query=National%20Women%E2%80%99s%20Health%20Network\" target=\"_blank\" rel=\"noopener\">funded<\/a> by the pro-abortion Ford Foundation.<\/p>\n<p>Like Creinin, Wells and Coeytaux suggest that the FDA regulations do not actually prohibit doctors from mailing the abortion pill. \u201cMost U.S. providers have taken the R.E.M.S. to mean that mifepristone cannot be mailed. We disagree. We think providers have clear latitude to \u2018dispense\u2019 the drug from their offices and then ship it to patients.&#8221;<\/p>\n<p>Yet the FDA <a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifeprex\">rules<\/a> specify that the abortion pill must \u201cbe dispensed <em><strong>in<\/strong> <\/em>certain healthcare settings, specifically, clinics, medical offices, and hospitals,\u201d not\u00a0\u201cin retail pharmacies\u201d and \u201cover the Internet.\u201d And the current FDA label (<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020687s022lbl.pdf\" target=\"_blank\" rel=\"noopener\">2019<\/a>) reads, \u201cMifeprex must be dispensed to patients <em><strong>only in<\/strong><\/em> certain healthcare settings.\u201d (emphases added)<\/p>\n<div id=\"attachment_223661\" style=\"width: 885px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-223661\" decoding=\"async\" loading=\"lazy\" class=\" wp-image-223661\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-website-shows-abortion-pills-can-only-be-dispensed-in-a-clinic-or-hc-facility.jpg\" alt=\"Image: FDA website shows abortion pills can only be dispensed in a clinic or HC facility\" width=\"875\" height=\"407\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-website-shows-abortion-pills-can-only-be-dispensed-in-a-clinic-or-hc-facility.jpg 1769w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-website-shows-abortion-pills-can-only-be-dispensed-in-a-clinic-or-hc-facility-300x140.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-website-shows-abortion-pills-can-only-be-dispensed-in-a-clinic-or-hc-facility-768x357.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-website-shows-abortion-pills-can-only-be-dispensed-in-a-clinic-or-hc-facility-700x326.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-website-shows-abortion-pills-can-only-be-dispensed-in-a-clinic-or-hc-facility-500x233.jpg 500w\" sizes=\"(max-width: 875px) 100vw, 875px\" \/><p id=\"caption-attachment-223661\" class=\"wp-caption-text\">FDA website shows abortion pills can only be dispensed in a clinic or HC facility<\/p><\/div>\n<p>As shown below, the FDA&#8217;s policy regarding REMS requirements during\u00a0<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-provides-update-patient-access-certain-rems-drugs-during-covid-19\" target=\"_blank\" rel=\"noopener\">COVID-19<\/a>\u00a0does not change the requirement for in-person visits.<\/p>\n<div id=\"attachment_223674\" style=\"width: 748px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-223674\" decoding=\"async\" loading=\"lazy\" class=\" wp-image-223674\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-Guidance-for-REMS-under-COVID19.jpg\" alt=\"Image: FDA Guidance for REMS under COVID19\" width=\"738\" height=\"745\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-Guidance-for-REMS-under-COVID19.jpg 835w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-Guidance-for-REMS-under-COVID19-150x150.jpg 150w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-Guidance-for-REMS-under-COVID19-297x300.jpg 297w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-Guidance-for-REMS-under-COVID19-768x775.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-Guidance-for-REMS-under-COVID19-693x700.jpg 693w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-Guidance-for-REMS-under-COVID19-80x80.jpg 80w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/05\/FDA-Guidance-for-REMS-under-COVID19-500x505.jpg 500w\" sizes=\"(max-width: 738px) 100vw, 738px\" \/><p id=\"caption-attachment-223674\" class=\"wp-caption-text\">FDA Guidance for REMS under COVID19<\/p><\/div>\n<p>Despite this, Wells claims several abortion doctors \u201chave started shipping the pills or are planning to soon,\u201d in direct violation of FDA regulations. Should the FDA fail to put a stop to these violations and allow the abortion pill by mail, they could open the floodgates to what may become the largest expansion of abortion in decades.<\/p>\n<p style=\"text-align: center;\"><em><strong><a href=\"https:\/\/www.facebook.com\/liveactionnewsonline\/\">\u201cLike\u201d Live Action News on Facebook<\/a> for more pro-life news and commentary!<\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A recent New York Times opinion piece suggests abortionists should dispense the abortion pill through the mail, in violation of the Food and Drug Administration\u2019s Risk Evaluation Mitigation Strategy (REMS). The Times piece quotes extensively from the co-founders of abortion advocacy group Plan C, which publishes a &#8220;report card&#8221; encouraging women to get abortion pills [&hellip;]<\/p>\n","protected":false},"author":303,"featured_media":186652,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[9953],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>New York Times writer advocates for abortion pill by mail, flouting FDA safety regulations<\/title>\n<meta name=\"description\" content=\"A recent NYT opinion piece suggests abortionists should dispense the abortion pill through the mail, in violation of the FDA\u2019s safety regulations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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