{"id":2678968,"date":"2026-10-08T14:19:00","date_gmt":"2026-10-08T18:19:00","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/utm_sourcerssutm_mediumrssutm_campaignfda-says-it-wont-act-on-abortion-drugs-till-march-2-years-after-pledging-to-review-safety-concerns-2\/"},"modified":"2026-10-08T14:20:13","modified_gmt":"2026-10-08T18:20:13","slug":"utm_sourcerssutm_mediumrssutm_campaignfda-says-it-wont-act-on-abortion-drugs-till-march-2-years-after-pledging-to-review-safety-concerns-2","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/utm_sourcerssutm_mediumrssutm_campaignfda-says-it-wont-act-on-abortion-drugs-till-march-2-years-after-pledging-to-review-safety-concerns-2\/","title":{"rendered":"FDA Says It Won&#8217;t Act On Abortion Drugs Till March, 2 Years After Pledging To Review Safety Concerns"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">36<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Futm_sourcerssutm_mediumrssutm_campaignfda-says-it-wont-act-on-abortion-drugs-till-march-2-years-after-pledging-to-review-safety-concerns-2%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=2678968&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><p>The FDA is planning to finalize its safety review of the most widely used abortion pills, specifically mifepristone, by March 2027, according to a court document. this delay comes over two years after officials like Robert F. Kennedy Jr. and Marty Makary announced plans to study the drug&#8217;s safety.The FDA is using data from Sentinel to conduct its study and has stated that no review is required to reinstate certain safeguards, such as in-person doctor visits, which were previously removed under President Biden\u2019s governance. However,the agency will not amend existing safety protocols until after completing its review,which is now projected to extend into 2027.<\/p>\n<p>Critics, including pro-life groups, suspect the delay may be politically motivated, especially as the court-ordered deadline and upcoming elections approach. There are concerns that many women could face serious adverse events during the review period, with estimates suggesting over 18,000 women might experience complications. The FDA&#8217;s review process has faced criticism for being insufficient and biased, with recent analyses questioning the safety standards and the removal of in-person dispensing requirements, which some studies indicate increased risks.<\/p>\n<p>Legal and political pressure continues, with court cases and legislative efforts urging the FDA to restore safeguards and respond promptly. Despite the prolonged review process, the FDA\u2019s actions remain a point of contention, with many advocating for immediate safety measures and transparency.  <\/p>\n<p class=\"readmore\">\n    <button onclick=\"showReadMore()\" id=\"readmorebtn\">Read more&#8230;<\/button>\n<\/p>\n<hr id=\"line\">\n<span id=\"more\"><\/p>\n<div>\n<p>The U.S. Food and Drug Administration plans to finalize its long-awaited safety review of the most prolific abortion pills on the market, but it won\u2019t do so until March 2027, according to a court document filed on Wednesday.<\/p>\n<p>The expected completion date comes more than two years after U.S. Health and Human Services Secretary <a href=\"https:\/\/www.finance.senate.gov\/hearings\/hearingto-consider-the-nomination-of-robert-f-kennedy-jr-of-california-to-be-secretary-of-health-and-human-services\" target=\"_blank\" rel=\"noreferrer noopener\">Robert F. Kennedy Jr.<\/a> and former FDA Commissioner <a href=\"https:\/\/www.npr.org\/sections\/shots-health-news\/2025\/03\/06\/nx-s1-5319894\/fda-commissioner-makary\" target=\"_blank\" rel=\"noreferrer noopener\">Marty Makary<\/a> pledged to \u201cstudy the safety\u201d of abortion pills and approximately three months after the FDA anticipates a wrap on its mifepristone study. According to the five-page filing, the FDA is \u201cusing a variety of data sources contained within Sentinel, a distributed database, to conduct the study.\u201d<\/p>\n<figure><\/figure>\n<p>No <a href=\"https:\/\/www.fda.gov\/media\/128651\/download\" target=\"_blank\" rel=\"noreferrer noopener\">review is required<\/a> for the regulatory agency to reinstate some of the abortion pill safeguards, including an in-person doctor visit, that were stripped at <a href=\"https:\/\/www.barrons.com\/articles\/us-makes-abortion-pills-by-mail-permanent-not-just-for-pandemic-01639698006\" target=\"_blank\" rel=\"noreferrer noopener\">President Joe Biden\u2019s behest<\/a>. The FDA <a href=\"https:\/\/thefederalist.com\/2026\/01\/29\/fda-wants-pause-on-landmark-abortion-pill-suit-pro-lifers-say-it-will-cost-lives\/\" target=\"_blank\" rel=\"noreferrer noopener\">confirmed<\/a>, however, that it will not consider amending the Risk Evaluation and Mitigation Strategy that currently allows anyone to order mifepristone to any state regardless of its abortion laws until after the \u201ccompletion of its study and review.\u201d <\/p>\n<figure>\n<p><span><\/p>\n<blockquote data-width=\"500\" data-dnt=\"true\">\n<p lang=\"en\" dir=\"ltr\">By my estimation, 18,000+ women will face serious adverse events related to mifepristone abortions during the 3+ months between when <a href=\"https:\/\/x.com\/FDA?ref_src=twsrc%5Etfw\">@FDA<\/a> has its mifepristone safety study results in mid-December and when it publishes its final report in March. <a href=\"https:\/\/t.co\/vY8NxehwoI\">https:\/\/t.co\/vY8NxehwoI<\/a><\/p>\n<p>\u2014 Jamie Bryan Hall (@Mr_Jamie_B_Hall) <a href=\"https:\/\/x.com\/Mr_Jamie_B_Hall\/status\/2108026373860167716?ref_src=twsrc%5Etfw\">October 8, 2026<\/a><\/p><\/blockquote>\n<p><\/span> <\/p>\n<\/figure>\n<p>This REMS evaluation, the agency claimed, will <a href=\"https:\/\/x.com\/CaroleNovielli\/status\/2108026790564491770?s=20\" target=\"_blank\" rel=\"noreferrer noopener\">consider<\/a> \u201carguments and information submitted to the Agency in multiple pending Citizen Petitions\u201d and could affect the projected March 2027 \u201cestimated date of completion.\u201d <\/p>\n<figure><\/figure>\n<p>The long-awaited mifepristone status update was announced the same day a court-ordered deadline for the FDA to share its review plans was set to expire.<\/p>\n<p>In his <a href=\"https:\/\/litigationtracker.law.georgetown.edu\/wp-content\/uploads\/2025\/10\/Louisiana_2026.04.07_OPINION.pdf\">Apr. 7 opinion<\/a> in the landmark abortion pill lawsuit <em>Louisiana v. FDA<\/em>, U.S. District Judge David Joseph of the Western District of Louisiana granted the FDA a stay that would allow its current mail-order abortion scheme to continue as long as the agency agreed to provide the court with a review status update \u201con or before six months from the date of this order.\u201d <\/p>\n<p>Joseph warned that \u201cshould the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court\u2019s analysis \u2013 and the weight accorded to these factors \u2013 will inevitably change.\u201d<\/p>\n<p>\u201cFDA has an obligation to act with all deliberate speed to review its past actions and complete a thorough analysis that addresses the deficiencies it has acknowledged,\u201d Joseph wrote. \u201cThe parties and the American public deserve nothing less.\u201d<\/p>\n<p>Until Wednesday, the FDA\u2019s website claimed that \u201cThe next steps of the mifepristone safety study will be data exploration, evaluation of data integrity, and implementation of the analyses, validation, and peer-review.\u201d <\/p>\n<p>\u201cIn academia, studies like these, including the appropriate steps described above, often take approximately a year or more to conduct. The current agency plan is to have this study done sooner than that timeframe. Drug safety is a paramount issue with all drugs that the agency approves. We will continue to keep you posted on this project,\u201d the <a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation\" target=\"_blank\" rel=\"noreferrer noopener\">FAQ entry states<\/a>.<\/p>\n<p>The FDA did not answer The Federalist\u2019s questions about whether it made any measurable review progress over the last year. Nor did the agency answer who is leading the mifepristone review after Makary\u2019s exit. <\/p>\n<p>Ever since the FDA promised a review in 2025, pro-life leaders have <a href=\"https:\/\/www.dailysignal.com\/2026\/10\/06\/fda-update-court-deadly-drug\/\" target=\"_blank\" rel=\"noreferrer noopener\">expressed suspicion<\/a> that the FDA is slow-walking its evaluation of abortion pills until after the 2026 midterm elections. Those fears amplified as the court-ordered deadline for the regulatory agency\u2019s safety evaluation of the most popular abortion drug on the market neared.<\/p>\n<p>\u201cMore than one year ago, HHS Secretary Kennedy and former FDA Commissioner Makary announced the safety review of the abortion pill, mifepristone, had officially started. Since then, we have seen no public evidence this review has actually begun, much less any substantial progress made,\u201d CEO of Americans United for Life John Mize <a href=\"https:\/\/aul.org\/2026\/10\/06\/ceo-statement-fda-to-provide-court-ordered-oct-7-update\/\" target=\"_blank\" rel=\"noreferrer noopener\">said<\/a> in a statement on Oct. 7.<\/p>\n<p>  Sen. Josh Hawley told The Federalist in February that, <a href=\"https:\/\/www.dailysignal.com\/2025\/12\/09\/exclusive-makary-responds-report-saying-he-slow-walked-abortion-pill-safety-review\/\" target=\"_blank\" rel=\"noreferrer noopener\">despite previously confirming<\/a> that the mifepristone review is in \u201cdata acquisition phase,\u201d the FDA is \u201cnot even reviewing any data yet.\u201d<\/p>\n<p>\u201cWe can\u2019t wait forever for them to do it,\u201d Louisiana Attorney General Liz Murrill also told The Federalist in February. \u201cPeople are suffering severe consequences from this. The system is suffering too.\u201d<\/p>\n<p>Polling suggests a <a href=\"https:\/\/thefederalist.com\/2025\/10\/28\/trumps-trusted-pollster-even-pro-aborts-say-mifepristone-is-dangerous-and-needs-fda-regulation\/\" target=\"_blank\" rel=\"noreferrer noopener\">majority of likely voters<\/a> want the FDA to protect women from the dangers of abortion pills. <a href=\"https:\/\/thefederalist.com\/2026\/02\/24\/despite-promise-to-be-pro-life-ally-trump-admin-wont-regulate-abortion-drug-endangering-women\/\" target=\"_blank\" rel=\"noreferrer noopener\">Pro-life leaders<\/a>, <a href=\"https:\/\/thefederalist.com\/2025\/10\/10\/51-gop-senators-urge-hhs-fda-to-end-distribution-of-dangerous-abortion-drug\/\" target=\"_blank\" rel=\"noreferrer noopener\">Congress<\/a>, plaintiffs in the <em>Louisiana v. FDA<\/em> case, and <a href=\"https:\/\/thefederalist.com\/2026\/10\/01\/scotus-asked-to-stop-blue-states-from-shielding-abortion-drug-dealers\/\" target=\"_blank\" rel=\"noreferrer noopener\">Republican attorneys general<\/a> alike have also urged the administration to at least reinstate the mifepristone safeguards stripped by President Joe Biden\u2019s FDA. The only official mifepristone movement from the FDA, however, occurred in Oct. 2026 when the agency <a href=\"https:\/\/thefederalist.com\/2025\/10\/02\/after-promising-review-of-deadly-abortion-pill-fda-greenlights-a-copycat-version\/\" target=\"_blank\" rel=\"noreferrer noopener\">approved<\/a> a generic version of the abortion pill for sale and distribution. <\/p>\n<p>The push for action intensified this week when a new <a href=\"https:\/\/issuesinlawandmedicine.com\/articles\/a-critical-analysis-of-the-fdas-2021-mifepristone-rems-modification-rationale-review\/#elementor-toc__heading-anchor-7\" target=\"_blank\" rel=\"noreferrer noopener\">critical analysis<\/a> from the Charlotte Lozier Institute found that the FDA\u2019s 2021 review of the mifepristone REMS program was \u201cinsufficient\u201d and \u201cmay have even been biased towards pro-abortion groups.\u201d<\/p>\n<figure>\n<p><span><\/p>\n<blockquote data-width=\"500\" data-dnt=\"true\">\n<div lang=\"en\" dir=\"ltr\">\n<p>Abortion activists claim mifepristone is \u201csafer than Tylenol,\u201d and that the FDA\u2019s approval and relaxed oversight of mifepristone are \u201cgrounded in science.\u201d <\/p>\n<p>But our new peer-reviewed paper exposes that <a href=\"https:\/\/x.com\/FDA?ref_src=twsrc%5Etfw\">@FDA<\/a>&#8216;s review of mifepristone safeguards did not sufficiently show that\u2026<\/p>\n<\/div>\n<p>\u2014 Charlotte Lozier Institute (@LozierInstitute) <a href=\"https:\/\/x.com\/LozierInstitute\/status\/2107806908430123308?ref_src=twsrc%5Etfw\">October 7, 2026<\/a><\/p><\/blockquote>\n<p><\/span> <\/p>\n<\/figure>\n<p><a href=\"https:\/\/eppc.org\/publication\/fact-sheet-data-reveals-the-fdas-removal-of-in-person-dispensing-requirement-increased-the-dangers-of-the-abortion-pill\/\" target=\"_blank\" rel=\"noreferrer noopener\">Data<\/a> suggests the subsequent removal of the in-person dispensing requirement increased the dangers of the abortion pill. More than <a href=\"https:\/\/thefederalist.com\/2025\/04\/28\/study-rate-of-serious-or-life-threatening-complications-after-abortion-pill-is-22-times-higher-than-fda-claims\/\" target=\"_blank\" rel=\"noreferrer noopener\">one in 10 women<\/a> who take the prolific abortion pill suffer serious additional complications such as hemorrhage or infection. That same \u201clargest known study of the abortion pill\u201d determined the risk of experiencing a life-threatening event linked to mifepristone is at least 22 times higher than what the FDA and mifepristone manufacturer Danco claim.<\/p>\n<p>\u201cGiven that the Biden administration relied on insufficient evidence and flawed assumptions in removing the in-person dispensing requirement, the FDA should restore that safeguard immediately. And it can do so by settling its litigation against Louisiana,\u201d SBA Pro-Life America President Marjorie Dannenfelser said in her <a href=\"https:\/\/sbaprolife.org\/newsroom\/press-releases\/statement-ahead-fdas-oct-7-deadline-mifepristone-study-update\" target=\"_blank\" rel=\"noreferrer noopener\">statement<\/a> commenting on the Oct. 7 deadline.<\/p>\n<p>The Alliance Defending Freedom legal counsel representing Louisiana and abortion pill poisoning survivor Rosalie Markezich in their case against the FDA told the <a href=\"https:\/\/www.dailysignal.com\/2026\/10\/06\/fda-update-court-deadly-drug\/\" target=\"_blank\" rel=\"noreferrer noopener\">Daily Signal<\/a> prior to the FDA\u2019s filing that a vague update could mean plaintiffs \u201ccould go back down at the district court while the 5th Circuit is pending and continue litigating there.\u201d <\/p>\n<p>\u201cEven if the agency were to find that mifepristone safety review concludes that they needed to return safeguards, they still would have to go through an administrative process, and the earliest that we would see relief would be the end of 2027-2028 at this point, and that does nothing to alleviate or fix or cure the lawfulness of the 2023 REMS decision \u2014 that\u2019s the thing that we\u2019re actually litigating in court \u2014 no matter what they find in this study, that decision in 2023 by the FDA was still unlawful,\u201d the counsel added.<\/p>\n<hr>\n<p>      Jordan Boyd is an award-winning staff writer at The Federalist and producer of \u201cThe Federalist Radio Hour.\u201d Her work has also been featured in The Daily Wire, Fox News, and RealClearPolitics. Jordan graduated from Baylor University where she majored in political science and minored in journalism. Follow her on X @jordanboydtx.<\/p>\n<\/p><\/div>\n<p><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA delays abortion pill safety review until March 2027<\/p>\n","protected":false},"author":490,"featured_media":2678969,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/thefederalist.com\/wp-content\/uploads\/2026\/10\/FDA-e1791379278775.jpg","fifu_image_alt":"","footnotes":""},"categories":[33651],"tags":[62653,8468,37167,86917],"class_list":["post-2678968","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-western-journal","tag-abortion-drugs","tag-fda","tag-healthcare-policy","tag-regulatory-delay"],"fifu_image_url":"https:\/\/thefederalist.com\/wp-content\/uploads\/2026\/10\/FDA-e1791379278775.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2678968","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/490"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2678968"}],"version-history":[{"count":3,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2678968\/revisions"}],"predecessor-version":[{"id":2678972,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2678968\/revisions\/2678972"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2678969"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2678968"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2678968"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2678968"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}