{"id":229152,"date":"2020-08-22T09:08:30","date_gmt":"2020-08-22T14:08:30","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=229152"},"modified":"2020-08-21T00:58:54","modified_gmt":"2020-08-21T05:58:54","slug":"abortion-pill-manufacturer-training-flouts-fda","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/abortion-pill-manufacturer-training-flouts-fda\/","title":{"rendered":"Abortion pill manufacturer funds abortion training curriculum that flouts FDA safety protocol"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p>The abortion industry does not look favorably upon regulations. Examples of this can be found in its years of litigation against every kind of regulation, including parental notification laws for minors seeking abortions, 24-hour waiting periods, and informed consent measures. Now, the manufacturer of the\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\" target=\"_blank\" rel=\"noopener\">abortion pill<\/a>\u00a0\u2014 which is tasked with upholding Food and Drug Administration&#8217;s (FDA) safety requirements, certifying prescribers, and removing violators \u2014 is inexplicably funding an abortion training curriculum which <em>openly contradicts<\/em> the FDA&#8217;s safety standards for the drug.<\/p>\n<p>Abortion pill manufacturer Danco Laboratories has given an &#8220;unrestricted educational grant&#8221; to the TEACH\u00a0<a href=\"https:\/\/workbook.pressbooks.com\/\">Early Abortion Training Curriculum<\/a>, which openly\u00a0promotes self-managed (DIY) abortion, illegal abortion pill websites, and later gestational limits, in direct vioilation of FDA safety measures called REMS.\u00a0Under <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/rems\/Mifepristone_2019_04_11_REMS_Full.pdf\" target=\"_blank\" rel=\"noopener\">REMS<\/a>, Danco is required to &#8220;ensure that healthcare providers who prescribe their mifepristone [abortion pill] are specially certified in accordance with the requirements.&#8221; The manufacturer must also &#8220;de-certify healthcare providers who do not maintain compliance with certification requirements.&#8221;<\/p>\n<p>The TEACH\u00a0<a href=\"https:\/\/workbook.pressbooks.com\/\">Early Abortion Training Curriculum<\/a>\u00a0was <a href=\"https:\/\/intranet.bixbycenter.ucsf.edu\/training\/training\/teach.html\" target=\"_blank\" rel=\"noopener\">established<\/a>\u00a0in <a href=\"https:\/\/www.teachtraining.org\/about\/\" target=\"_blank\" rel=\"noopener\">2003<\/a>\u00a0with financial help from the Packard Foundation, one of Danco&#8217;s original funders. The curriculum&#8217;s website notes:<\/p>\n<p style=\"padding-left: 30px;\"><em>In 2002, the Bixby Center launched the\u00a0<a href=\"http:\/\/ansirh.org\/\" target=\"_blank\" rel=\"noopener\">Advancing New Standards in Reproductive Health (ANSIRH)<\/a>\u00a0Program&#8230;to enhance access to abortion. With seed funding from the Packard Foundation, ANSIRH established a Planned Parenthood training site for motivated residents and practicing physicians to learn early abortion procedures. In July 2003, support from an anonymous donor allowed the Center to expand its training initiatives by pioneering the TEACH Project&#8230;<\/em><\/p>\n<p>TEACH\u00a0<a href=\"https:\/\/workbook.pressbooks.com\/front-matter\/acknowledgments-2\/\" target=\"_blank\" rel=\"noopener\">acknowledges<\/a>\u00a0receiving\u00a0\u201c[s]upport, sponsorship, staffing and\/or collaboration\u201d from the National Abortion Federation, Gynuity Health Projects, ANSIRH, Planned Parenthood, the Society of Family Planning (SFP), Danco, and others. The curriculum&#8217;s website <a href=\"https:\/\/workbook.pressbooks.com\/front-matter\/advisory-committee-2\/\" target=\"_blank\" rel=\"noopener\">admits<\/a>\u00a0that it &#8220;receives unrestricted educational grant funding from Danco, LLC,\u201d and has for <a href=\"http:\/\/www.teachtraining.org\/trainingworkbook\/Early-Abortion-Training-Workbook-2016-2.pdf\" target=\"_blank\" rel=\"noopener\">years<\/a>.<\/p>\n<p>TEACH flouts multiple FDA requirements, as seen below.<\/p>\n<p><strong>LATER GESTATIONAL LIMITS<\/strong><\/p>\n<p>The abortion pill regimen \u2014 which consists of the drugs mifepristone (also called Mifeprex) and misoprostol \u2014\u00a0has only been <a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifeprex\" target=\"_blank\" rel=\"noopener\">approved<\/a>\u00a0by the FDA for abortion up to 10 weeks of pregnancy (70 days). Yet this <em>Danco-funded<\/em> abortion training curriculum recommends medication abortion through 11 weeks (77 days), beyond the FDA-approved limit.<\/p>\n<p>It is important to note that as pregnancy progresses, the <a href=\"https:\/\/archive.liveaction.org\/news\/planned-parenthood-abortion-pill-fda-limit-failing\/\" target=\"_blank\" rel=\"noopener\">failure<\/a>\u00a0rate of the\u00a0abortion pill increases, as does the risk of complications.<\/p>\n<div id=\"attachment_229169\" style=\"width: 815px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-229169\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-229169 size-full\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-at-11-weeks-evidence-based-regimen.jpg\" alt=\"Image: TEACH abortion training Medication abortion at 11 weeks evidence based regimen\" width=\"805\" height=\"448\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-at-11-weeks-evidence-based-regimen.jpg 805w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-at-11-weeks-evidence-based-regimen-300x167.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-at-11-weeks-evidence-based-regimen-768x427.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-at-11-weeks-evidence-based-regimen-700x390.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-at-11-weeks-evidence-based-regimen-500x278.jpg 500w\" sizes=\"(max-width: 805px) 100vw, 805px\" \/><p id=\"caption-attachment-229169\" class=\"wp-caption-text\">TEACH abortion training Medication abortion at 11 weeks evidence based regimen<\/p><\/div>\n<p>The TEACH curriculum suggests abortion counselors should be selective in how they sell abortion to clients. TEACH recommends against saying, \u201cYour baby is eight weeks old,\u201d and instead refers to the preborn child as &#8220;a pregnancy.&#8221; This recommendation matches the testimonies of many former Planned Parenthood workers.<\/p>\n<p>A medication abortion will most likely result in the child being expelled by the woman at home, possibly alone. TEACH suggests that, \u201cIf the patient is anxious about seeing the pregnancy or fetal tissue, consider showing a drawing&#8230; If they are not comfortable, they may prefer an aspiration abortion.\u201d<\/p>\n<p>A drawing would likely not prepare a woman for the potential trauma of seeing the recognizably human shape of her child as he or she is expelled from the womb.<\/p>\n<p>The TEACH manual admits that an embryo at 6 \u2013 6.5 weeks LMP <strong>has cardiac activity<\/strong> and &#8220;grows 1 mm per day thereafter until 12-14 weeks.\u201d (A preborn child&#8217;s heart begins to beat <a href=\"https:\/\/archive.liveaction.org\/news\/babys-heart-begins-to-beat-as-early-as-16-days-after-conception-study-finds\/\">between 16<\/a> and <a href=\"https:\/\/www.ehd.org\/dev_article_unit4.php#heartbeat\">21 days<\/a> after fertilization.) The abortion curriculum also identifies how an \u201c[a]bsence of embryo with heartbeat,\u201d is potentially a sign of early pregnancy loss.<\/p>\n<div id=\"attachment_229160\" style=\"width: 832px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-229160\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-229160 size-full\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-gestational-landmarks.jpg\" alt=\"Image: TEACH abortion training gestational landmarks\" width=\"822\" height=\"241\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-gestational-landmarks.jpg 822w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-gestational-landmarks-300x88.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-gestational-landmarks-768x225.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-gestational-landmarks-700x205.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-gestational-landmarks-500x147.jpg 500w\" sizes=\"(max-width: 822px) 100vw, 822px\" \/><p id=\"caption-attachment-229160\" class=\"wp-caption-text\">TEACH abortion training gestational landmarks<\/p><\/div>\n<p><strong>SELF-MANAGED ABORTION<\/strong><\/p>\n<p>TEACH describes a <a href=\"https:\/\/archive.liveaction.org\/news\/dangerous-self-abortion-pill-push\/\" target=\"_blank\" rel=\"noopener\">self-managed abortion<\/a>\u00a0(SMA) as \u201cthe use of pills for abortion <em>without<\/em> the oversight by a licensed clinician.\u201d\u00a0But under the FDA&#8217;s <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/rems\/Mifepristone_2019_04_11_REMS_Full.pdf\" target=\"_blank\" rel=\"noopener\">safety protocol<\/a>, &#8220;Mifepristone must be dispensed to patients <em>only<\/em> in certain healthcare settings, specifically clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.&#8221;<\/p>\n<p>TEACH even <em>acknowledged<\/em> the FDA&#8217;s requirement, but stated that &#8220;Mifepristone can safely be taken at home though U.S. regulation still requires it be dispensed in a clinical setting by a clinician.&#8221;<\/p>\n<p><strong>UNAPPROVED ABORTION METHODS<\/strong><\/p>\n<p>The FDA has approved the previously mentioned abortion pill regimen of mifepristone and misoprostol. Yet, according to TEACH, &#8220;self-managed abortion&#8221; can also include methods\u00a0<em>unapproved<\/em>\u00a0by the FDA, such as \u201cmisoprostol alone\u201d as well as \u201cherbs and objects or substances inserted into the vagina or cervix\u201d and \u201cdeep abdomen massage.\u201d<\/p>\n<p>\u201cMisoprostol-only is a reasonable alternative to mifepristone-containing regimens when mifepristone is not available, though it is less effective,\u201d the TEACH curriculum states.<\/p>\n<p><strong>ILLEGAL ABORTION PILL WEBSITES<\/strong><\/p>\n<p>Under self-managed abortion, the manual lists as &#8220;resources&#8221; two websites working overseas to ship abortion pills globally and into the United States illegally: Aid Access and Women on Web. The FDA previously sent <a href=\"https:\/\/archive.liveaction.org\/news\/lawmakers-fda-illegal-abortion-pill-online\/\" target=\"_blank\" rel=\"noopener\">clear warnings<\/a> to websites that ship abortion pills <a href=\"https:\/\/archive.liveaction.org\/news\/promoting-illegal-abortion-pill-roulette-womens-lives\/\" target=\"_blank\" rel=\"noopener\">illegally<\/a> into the U.S.<\/p>\n<p>And yet, this abortion training manual funded by the abortion pill&#8217;s manufacturer offers no such warning.<\/p>\n<div id=\"attachment_229158\" style=\"width: 877px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-229158\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-229158 size-full\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-promotes-Illegal-websites.jpg\" alt=\"Image: TEACH abortion training Medication abortion promotes Illegal websites\" width=\"867\" height=\"407\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-promotes-Illegal-websites.jpg 867w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-promotes-Illegal-websites-300x141.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-promotes-Illegal-websites-768x361.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-promotes-Illegal-websites-700x329.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2020\/08\/TEACH-abortion-training-Medication-abortion-promotes-Illegal-websites-500x235.jpg 500w\" sizes=\"(max-width: 867px) 100vw, 867px\" \/><p id=\"caption-attachment-229158\" class=\"wp-caption-text\">TEACH abortion training Medication abortion promotes websites illegally distributing the abortion pill<\/p><\/div>\n<p><strong>LABS UNNECESSARY<\/strong><\/p>\n<p>Under the FDA&#8217;s REMS safety protocol, prescribers of the abortion pill must be able to &#8220;assess the duration of pregnancy accurately&#8221; and to &#8220;diagnose ectopic pregnancies.&#8221; Yet, TEACH suggests lab work is unnecessary unless the clinician suspects a need for it.<\/p>\n<p>\u201cNo labs are required unless: Rh if pregnancy dating &gt;56 days and unknown Rh,\u201d TEACH writes.<\/p>\n<p>TEACH also appears to have adopted the <a href=\"https:\/\/archive.liveaction.org\/news\/alarming-abortion-pill-ultrasounds-guess\/\" target=\"_blank\" rel=\"noopener\">no-test abortion protocol<\/a>, writing, \u201cIn early first trimester (&lt;70 days) pregnancy, LMP alone has been shown to be an accurate means of estimating gestational age with low rates of under- or overestimation in abortion evaluation to mid first trimester or 63 days.\u201d<\/p>\n<p>\u201cPairing bimanual exam with LMP dating may increase the accuracy of gestational age estimation,&#8221; TEACH writes, but emphasizes that such an exam \u201cis not required to proceed with a medication&#8230;.\u201d The manual notes that &#8220;if there are any signs or symptoms of ectopic pregnancy, an ultrasound may be warranted.\u201d<\/p>\n<p>\u201cAccurate pregnancy dating is a key component of the pre-abortion evaluation\u2026 When pregnancy dating cannot be determined by last menstrual period, ultrasound can be used. Ultrasound aids in pregnancy dating and the detection of abnormal pregnancy including ectopic pregnancy and early pregnancy loss,\u201d TEACH writes. However, the abortion training manual goes on to claim that \u201c[r]emoving unnecessary labs and visits can improve access and patient experience, without jeopardizing safety.\u201d<\/p>\n<p><strong>SURGICAL INTERVENTION SKILLS UNNECESSARY<\/strong><\/p>\n<p>According to the FDA&#8217;s REMS safety protocol, abortion pill prescribers must be able to &#8220;provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.&#8221;<\/p>\n<p>Yet, according to the Danco-funded TEACH curriculum, \u201cMedication abortion [abortion pill] is relatively easy to integrate into clinical practice, expands access to abortion care, and can be provided in settings without ultrasound or ability to provide uterine aspiration with appropriate referral option if needed.\u201d<\/p>\n<p>TEACH is <a href=\"https:\/\/www.teachtraining.org\/wp-content\/uploads\/2020\/07\/TEACH-Early-Abortion-Training-Curriculum-July-2020.pdf\" target=\"_blank\" rel=\"noopener\">published<\/a> by UCSF&#8217;s\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/paying-millions-abortion-training-taxpayers\/\" target=\"_blank\" rel=\"noopener\">Bixby Center for Global Reproductive Health<\/a>\u00a0and boasts <a href=\"https:\/\/workbook.pressbooks.com\/front-matter\/teach-early-abortion-training-curriculum\/\" target=\"_blank\" rel=\"noopener\">contributors and authors<\/a>\u00a0associated with UCSF as well as Planned Parenthood. Advisory committee\u00a0<a href=\"https:\/\/workbook.pressbooks.com\/front-matter\/advisory-committee-2\/\" target=\"_blank\" rel=\"noopener\">members<\/a>\u00a0include Dr. Daniel Grossman and Alice Mark, a medical director for the National Abortion Federation.<\/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>The abortion industry does not look favorably upon regulations. Examples of this can be found in its years of litigation against every kind of regulation, including parental notification laws for minors seeking abortions, 24-hour waiting periods, and informed consent measures. Now, the manufacturer of the\u00a0abortion pill\u00a0\u2014 which is tasked with upholding Food and Drug Administration&#8217;s [&hellip;]<\/p>\n","protected":false},"author":303,"featured_media":223707,"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>Abortion pill manufacturer funds abortion training curriculum that flouts FDA safety protocol<\/title>\n<meta name=\"description\" content=\"The manufacturer of the\u00a0abortion pill\u00a0is funding an abortion training curriculum which openly contradicts the FDA&#039;s standards for the drug.\" \/>\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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Her work has been published by many reputable media outlets. 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