--- title: Generic Abortion Pill Maker Sues FDA to Protect Access description: A generic-mifepristone maker sued the FDA to protect access to the medical abortion pill amid a welter of litigation. canonical: https://time.com/6273244/generic-abortion-pill-maker-sues-fda/ author: TIME article:opinion: false article:content_tier: free article:published_time: 2023-04-19T21:50:35.000Z article:modified_time: 2026-10-19T07:15:18.309Z article:section: Health og:title: Generic Abortion Pill Maker Sues FDA to Protect Access og:description: The lawsuit was filed by a small biotech firm following the Supreme Court's delay of a final decision on mifepristone until Friday og:url: https://time.com/6273244/generic-abortion-pill-maker-sues-fda/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt78f00a952b493326/698a3c200116822afc982f19/mifepristone-supreme-court.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 og:image:width: 5659 og:image:height: 3183 og:image:alt: mifepristone-supreme-court og:type: article twitter:card: summary_large_image twitter:title: Generic Abortion Pill Maker Sues FDA to Protect Access twitter:description: The lawsuit was filed by a small biotech firm following the Supreme Court's delay of a final decision on mifepristone until Friday twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt78f00a952b493326/698a3c200116822afc982f19/mifepristone-supreme-court.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 ---  # Generic Abortion Pill Maker Sues FDA to Protect Access > Sponsored content. 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Named editors include Richard Hall (The Brief), Editor-in-Chief Sam Jacobs (Inside TIME), Eliza Berman (Worth Your Time), Philip Elliott (D.C. Brief), Justin Worland (Future Proof) and Harry Booth (In the Loop). Health Matters is written by TIME's health desk. #### How do I sign up for a TIME newsletter? Go to time.com/newsletters, choose the newsletters you want and enter your email address. There is no cost and no subscription requirement. ### Sources * TIME Newsletters: [time.com/newsletters](/c/time-nl-network-2026q3/newsletters?i=72dcbd2c-3378-4eaf-8753-571a680768cc&cr=time-nl-network-2026q3-v1) ## Video: What Happens Next in the Fight Over Abortion Pills [Watch (HLS stream): What Happens Next in the Fight Over Abortion Pills](https://cdn.jwplayer.com/manifests/YWU1AZq9.m3u8) (3:17)  _Published 2023-04-14. On April 7, 2023, Texas Judge Matthew J. Kacsmaryk ordered the Food and Drug Administration to invalidate its 23-year-old approval of mifepristone, one of the components of a medication abortion, a ruling that would effectively remove the drug from the market. Hours later, a Federal Judge in Washington state ordered the FDA to not make any changes to mifepristone’s current availability. Since then, a Federal Appeals Court has ruled that it can stay on the market, but imposed sharp restrictions for accessing it._ by [Madlin Mekelburg, Fiona Rutherford, and Mary Anne Pazanowski/Bloomberg](https://time.com/author/bloomberg/) ## Madlin Mekelburg, Fiona Rutherford, and Mary Anne Pazanowski/Bloomberg Contributor Apr 19, 2023 9:50 PM UTC On April 7, 2023, Texas Judge Matthew J. Kacsmaryk ordered the Food and Drug Administration to invalidate its 23-year-old approval of mifepristone, one of the components of a medication abortion, a ruling that would effectively remove the drug from the market. Hours later, a Federal Judge in Washington state ordered the FDA to not make any changes to mifepristone’s current availability. Since then, a Federal Appeals Court has ruled that it can stay on the market, but imposed sharp restrictions for accessing it. by [Madlin Mekelburg, Fiona Rutherford, and Mary Anne Pazanowski/Bloomberg](https://time.com/author/bloomberg/) ## Madlin Mekelburg, Fiona Rutherford, and Mary Anne Pazanowski/Bloomberg Contributor Apr 19, 2023 9:50 PM UTC A generic-mifepristone maker sued the U.S. Food and Drug Administration to protect access to the medical abortion pill amid a [welter of litigation](https://time.com/6271557/new-abortion-pill-restrictions/) stretching from Texas to Washington. The lawsuit by GenBioPro Inc., filed Wednesday in federal court in Maryland, comes as the U.S. Supreme Court delayed until Friday a decision on which restrictions on the pill will remain in place after a federal judge in Texas [blocked the FDA’s approval of mifepristone](https://time.com/6270258/texas-abortion-pill-ruling-mifepristone/) in a separate lawsuit. GenBioPro makes most of the mifepristone sold in the U.S. It says in its [suit](https://assets.bwbx.io/documents/users/iqjWHBFdfxIU/rf4FK9K3HQm0/v0) that if the FDA is forced to comply with the Texas court order, the drug maker would face “imminent, catastrophic, and irreparable harm.” The FDA said it doesn’t comment on possible, pending or ongoing litigation. The Texas-based case was brought by a group of Christian doctors who contended that mifepristone is unsafe and never should have been granted approval. After U.S. District Judge Matthew Kacsmaryk in Amarillo issued an order this month temporarily blocking FDA approval of mifepristone, a federal appeals court said the [drug could remain available](https://time.com/6270733/abortion-pill-ruling-fda-explained/), with restrictions, while the lawsuit proceeds. **Read More**: [_Democratic States Are Stockpiling Abortion Pills to Preserve Access_](https://time.com/6272692/abortion-pill-stockpiling-democratic-states/) The appellate court reversed several regulatory changes approved by the FDA since 2016, including a decision to permit the drug to be distributed through the mail and prescribed via telehealth. Its ruling also appears to block the 2019 approval of GenBioPro’s generic version of mifepristone. The Supreme Court has paused implementation of the appeals court’s order and is set to decide by the end of the day on Friday whether the order will stay in place while the full case is litigated. The drug maker warned in its lawsuit that, should the order from the appeals court go into effect, “the result will be chaos.” “These circumstances are unprecedented,” according to the complaint. “No court in history has ever ‘stayed’ or ‘suspended’ a longstanding FDA approval, and FDA has no template for responding to—or implementing—those decisions.” **Read More**: [_How the Abortion Pill Ruling Could Limit the FDA’s Authority_](https://time.com/6270389/abortion-pill-ruling-fda-authority/) The FDA [first approved mifepristone for use in 2000](https://time.com/6271082/jane-henney-interview/), with strict safety regulations. Only certain doctors could prescribe the pill, and it had to be administered at the provider’s office. But the agency faced pressure for years from medical bodies and advocacy groups to loosen restrictions on the abortion pill, given the wealth of data supporting the drug’s safety and efficacy. After a law was passed in 2007 that expanded the FDA’s risk management authority, the agency created a program known as Risk Evaluation and Mitigation Strategy, or REMS. This was designed to ensure certain drugs—like antipsychotics and opioids—that carried greater risks were dispensed under stricter conditions. A few years later, the agency imposed a REMS on mifepristone, codifying the restrictions on the drug. After reviewing around 15 years of safety data and doing its own four-year assessment of the restrictions on the abortion pill, the FDA revised its rules in 2016 to allow the drug to be used through 10 weeks of pregnancy instead of seven. Such changes would be blocked under the order from the federal appeals court. The case is GenBioPro Inc. v. US Food and Drug Administration, 23-cv-01057, US District Court, District of Maryland. ## Transcript [00:00] A ruling by a Texas judge has left the legal experts and medical [00:04] professionals alike. Scrambling to understand what it means [00:08] when the FDA approves a drug. [00:10] And who, if anyone can question that decision, [00:14] I just can't believe that the there is a person in Texas who [00:20] thinks that they know more than the FDA in terms of what is a [00:25] safe medication and to try and remove a medication that we've [00:30] been using for abortions, miscarriage management and other [00:33] things In Obstetrics and gynaecology for more than 20 years [00:37] is [00:39] Completely absurd much like the daps decision last summer. [00:42] This news will and has already overwhelmed, [00:45] confused and height and fear. [00:46] Within the communities, we serve the judge ruled. [00:50] That me. Also known as the abortion pill which was approved [00:54] more than 20 years ago to induce abortion. [00:57] In the first trimester should no longer be approved. [01:01] The Department of Justice and the drugs maker have appealed [01:05] the decision and an appeals court. [01:06] Granted the appeal that means that for now, [01:10] the drug remains on the market and doctors can prescribe [01:13] it and patients can use it, but the legal status of the drug [01:18] remains uncertain, [01:20] The judge's ruling is the first time that the powers of the FDA [01:25] to approve. Drugs has been questioned by the courts and that's [01:29] a big deal. [01:29] Congress. Gave the FDA powers to review Drug Assessment [01:34] for safety and Effectiveness and make decisions about that based on [01:39] scientific evidence and to have a judge questioned [01:43] that decision and not process, could seriously undermine [01:47] the fda's authority. [01:48] And that's what health officials are most concerned about. [01:51] I spoke to the commissioner of the FDA who approved me for Christmas. [01:56] And that's what she's most worried about. [01:58] Is the precedent that this could set for questioning [02:01] the fda's decision or not. [02:03] Just me for christone, but other drugs as well. [02:06] And she said, she knew that. [02:09] When this drug came up for approval, [02:10] that it was very important for women's reproductive [02:13] Health, she instructed her staff to give the drug the same rigorous [02:17] scientific review process that [02:20] Used for every other drug that it approved and that's despite [02:24] the fact that as an abortion pill. [02:26] And at the time, the very first abortion pill, [02:29] there were political pressures. [02:31] However she said even then Roe v Wade, [02:35] had already been declared law and therefore it was lawful [02:39] to have an abortion and the climate was not as contentious [02:43] as it was today. [02:44] We're Roe. V Wade has been overturned by the Supreme Court [02:48] and some states ban abortion while other states continue [02:52] to allow it. [02:53] The situation means that even experts don't know what happens [02:57] next and everyone's looking to this case, [03:00] to better, understand how much it will undermine the fda's [03:04] authority and how much the FDA can rely on the powers that Congress [03:09] gave it to maintain that when it makes decisions about drugs, [03:14] like the abortion pill, that those decisions should stand. ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/6273244/generic-abortion-pill-maker-sues-fda/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6273244/generic-abortion-pill-maker-sues-fda/"},"headline":"Generic Abortion Pill Maker Sues FDA to Protect Access","datePublished":"2023-04-19T21:50:35.000Z","dateModified":"2026-10-19T07:15:18.309Z","description":"The lawsuit was filed by a small biotech firm following the Supreme Court's delay of a final decision on mifepristone until Friday.","url":"https://time.com/6273244/generic-abortion-pill-maker-sues-fda/","keywords":["abortion","wire","healthscienceclimate","bloomberg wire"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blt78f00a952b493326/698a3c200116822afc982f19/mifepristone-supreme-court.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Madlin Mekelburg, Fiona Rutherford, and Mary Anne Pazanowski/Bloomberg"}],"articleSection":"Health","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/blt78f00a952b493326/698a3c200116822afc982f19/mifepristone-supreme-court.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"mifepristone-supreme-court","caption":"mifepristone-supreme-court","creditText":"Anna Moneymaker—Getty Images","representativeOfPage":true}],"publisher":{"@type":"Organization","name":"Time","url":"https://time.com/","logo":{"@type":"ImageObject","url":"https://time.com/images/logo.png","width":528,"height":156},"foundingDate":"March 3, 1923","sameAs":["https://www.facebook.com/time","https://www.instagram.com/time/?hl=en","https://twitter.com/time","https://www.pinterest.com/timemagazine"]}},{"@context":"https://schema.org","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"item":{"@id":"https://time.com/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"https://time.com/tag/abortion/","name":"abortion"}},{"@type":"ListItem","position":3,"item":{"@id":"https://time.com/6273244/generic-abortion-pill-maker-sues-fda/","name":"Generic Abortion Pill Maker Sues FDA to Protect Access"}}]},{"@context":"https://schema.org","@type":"VideoObject","name":"What Happens Next in the Fight Over Abortion Pills","description":"On April 7, 2023, Texas Judge Matthew J. 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