---
title: "FDA to Continue Safety Review of Mifepristone Into 2027, Report Expected by March"
id: "stat-news-0-fda-says-its-safety-review-of-abortion-pill-will-continue-into-next-year"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-0-fda-says-its-safety-review-of-abortion-pill-will-continue-into-next-year"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "STAT News"
source_url: "https://www.statnews.com/2026/10/08/fda-mifepristone-abortion-pill-safety-review-continue-into-2027/?utm_campaign=rss"
published_at: "2026-10-08T15:02:53.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA to Continue Safety Review of Mifepristone Into 2027, Report Expected by March
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-0-fda-says-its-safety-review-of-abortion-pill-will-continue-into-next-year
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/2026/10/08/fda-mifepristone-abortion-pill-safety-review-continue-into-2027/?utm_campaign=rss)
- **Published At:** 2026-10-08T15:02:53.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- The FDA has told a court that its ongoing safety review of **mifepristone** will extend into next year, with a safety study expected to finish by mid-December and a report due no later than March 2027. - The agency provided the update in a court-ordered filing tied to litigation over mail delivery of the drug; the review was ordered by Health Secretary Robert F. Kennedy Jr. - The FDA is using a **statistical data mining method** applied to an electronic database of medical injury and adverse event reports from major health networks and insurers to search for unknown safety concerns. - The agency is also evaluating multiple petitions that request changes to how **mifepristone** is prescribed and distributed. - **Mifepristone** was first approved in 2000; the FDA has repeatedly affirmed its safety and has eased restrictions over time, including removing an in-person dispensing requirement. - The two-drug regimen of **mifepristone** followed by **misoprostol** is the most common form of abortion in the U.S. - Anti-abortion groups and some lawmakers have pushed the current administration to reexamine the pill, seeking restrictions; abortion opponents criticized the extended timeline as insufficiently decisive. - The update was provided in litigation brought by Louisiana challenging mail delivery of mifepristone as undermining the state’s abortion ban; the 5th U.S. Circuit Court of Appeals recently questioned aspects of that case. - The Supreme Court has temporarily blocked changes to the drug until it reviews the matter again, so any appellate rulings would not immediately alter access. - All details and quotes are reported by the Associated Press and summarized in STAT News' coverage; specific findings from the FDA’s safety study were not reported in the source.
## Clinical Analysis & Structured Key Points
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) [Health](https://www.statnews.com/category/health/) # FDA says its safety review of abortion pill will continue into next year ## Abortion opponents, hoping to see mifepristone’s use curtailed, condemned the timeline * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * [Save this story for later](https://www.statnews.com/my-account/saved/) * [Share this article](https://www.statnews.com/2026/10/08/fda-mifepristone-abortion-pill-safety-review-continue-into-2027/?utm_campaign=rss) ![Mifepristone orange box](https://www.statnews.com/wp-content/uploads/2023/02/GettyImages-1241524355-645x645.jpg) A box of the abortion pill mifepristone.ROBYN BECK/AFP via Getty Images By Associated Press Oct. 8, 2026 WASHINGTON — The [Food and Drug Administration](https://apnews.com/hub/us-food-and-drug-administration) says its ongoing safety review of the [nation’s main abortion pill](https://apnews.com/article/abortion-pills-mifepristone-louisiana-fda-trump-f7572a03f26e02fc0ac1e60b10f93925) will continue into next year, a timeline that was quickly condemned by abortion opponents hoping to see the drug’s use curtailed. The FDA gave a court-ordered update on its progress in a legal filing late Wednesday, providing the first substantive information about the controversial reevaluation ordered by [Health Secretary Robert F. Kennedy Jr.](https://apnews.com/hub/robert-f-kennedy-jr) Advertisement [Mifepristone](https://apnews.com/article/mifepristone-abortion-pill-supreme-court-1d2221251197a391c9bca833918e4554) was first approved by the FDA in 2000. The agency has repeatedly reaffirmed the pill’s safety and effectiveness over the years, in addition to easing a number of restrictions on the drug, including dropping a requirement that it be dispensed in person. But since President Donald Trump returned to the White House, anti-abortion groups and their allies in Congress have pushed the administration to revisit the pill, in the hopes of restricting its use. The FDA said in its filing that it expects to complete a safety study of the pill by mid-December this year. A report on the findings is expected “no later than March 2027,” after which the agency will decide whether to impose new restrictions or other changes on the drug’s use. Advertisement Related Story ![](https://www.statnews.com/wp-content/uploads/2026/09/GettyImages-2296937316-768x432.jpg) ### [FDA commissioner nominee Heidi Overton is ignoring the science on abortion drug](https://www.statnews.com/2026/09/25/heidi-overton-confirmation-hearing-mifepristone-abortion-evasive/) Gavin Oxley of Americans United for Life, an anti-abortion group, criticized the move as a lack of “true leadership” by Trump administration officials. “The administration continues to find itself on the wrong side of women’s health, clearly uninterested in mitigating the ongoing harms caused by the abortion pill,” Oxley said. The two-drug regimen of mifepristone, combined with a second drug misoprostol, is the most common form of abortion in the U.S. The FDA was directed to provide the latest update by a federal judge in a case brought by the state of Louisiana alleging that mail-delivery of mifepristone undermines the state’s abortion ban. It’s one of several state lawsuits related to mifepristone winding their way through the courts. Last month a [three-judge panel for the 5th U.S. Circuit Court of Appeals](https://apnews.com/article/abortion-pills-telehealth-ac00f11d879eb890b572d0a5eb79dae4) questioned the merits of Louisiana’s case, including whether the state had the legal standing to challenge FDA’s oversight of mifepristone. Any ruling from the 5th Circuit on the Louisiana case would not immediately change the landscape because the [Supreme Court has blocked changes](https://apnews.com/article/supreme-court-mifepristone-abortion-louisiana-637acaa2f233de067e3756bea50bd723) to the drug until it sees the case again. Related Story ![](https://www.statnews.com/wp-content/uploads/2022/06/AP22168429788721-768x432.jpg) ### [Supreme Court temporarily extends women’s access to a widely used abortion pill](https://www.statnews.com/2026/05/11/supreme-court-temporarily-extends-mifepristone-abortion-pill-access/) The FDA said Wednesday it is using a “statistical data mining method” to discover “unknown safety concerns,” that may exist with the drug. The data comes from an electronic database that collects reports of medical injuries and drug side effects from major health networks and insurers. In addition to the safety study, the agency said it is considering a number of petitions proposing changes to how mifepristone is prescribed and distributed. Abortion opponents have focused most of their efforts on a 2021 decision allowing doctors to prescribe the drug online and send it through the mail during COVID-19. That decision, made permanent under President Joe Biden in 2023, had the effect of undermining a number of state abortion bans, since women can receive the drug through the mail. — Matthew Perrone _The Associated Press’ health and science coverage receives financial support from the[AP Fund for Journalism](https://www.apfj.org/) and private foundations. AP is solely responsible for all content. Find AP’s [standards](https://www.ap.org/about/standards-for-working-with-outside-groups/) for working with philanthropies, a list of supporters and funded coverage areas at [AP.org](https://www.ap.org/about/supporting-ap/)._ Advertisement [abortion](https://www.statnews.com/topic/abortion/), [FDA](https://www.statnews.com/topic/fda/), [Pharmaceuticals](https://www.statnews.com/topic/pharmaceuticals/) [Submit a correction request](https://www.statnews.com/contact/?how_can_we_help_=Editorial%20Correction%20Request)[Reprints](https://www.parsintl.com/publications/stat/) 1. Associated Press ![](https://www.statnews.com/wp-content/themes/stat/images/article-new/envelope-open.svg) ![](https://www.statnews.com/wp-content/uploads/2023/06/Morning-Rounds-Logo-Black-640x295.png) ### Newsletter Understand how science, health policy, and medicine shape the world every day Please enter a valid email address. 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