--- title: What Happens Next in the Fight Over Abortion Pills description: Here’s how the supply of abortion pills may change after a Texas judge's ruling on mifepristone. canonical: https://time.com/6270733/abortion-pill-ruling-fda-explained/ author: Alice Park article:opinion: false article:content_tier: free article:published_time: 2023-04-12T17:03:07.000Z article:modified_time: 2026-10-19T07:15:07.105Z article:section: Health og:title: What Happens Next in the Fight Over Abortion Pills og:description: Here’s how the supply of abortion pills may change after a Texas judge's ruling on mifepristone og:url: https://time.com/6270733/abortion-pill-ruling-fda-explained/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt859822cec5dbc37d/698a3bee16d8847642c3bb9d/mifepristone-abortion-pill-supply.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 og:image:width: 2400 og:image:height: 1350 og:image:alt: Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023 og:type: article twitter:card: summary_large_image twitter:title: What Happens Next in the Fight Over Abortion Pills twitter:description: Here’s how the supply of abortion pills may change after a Texas judge's ruling on mifepristone twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt859822cec5dbc37d/698a3bee16d8847642c3bb9d/mifepristone-abortion-pill-supply.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 ---  # What Happens Next in the Fight Over Abortion Pills > Sponsored content. 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Its audience is broadly health-conscious, with a professional core of clinicians, researchers, public-health professionals, life-sciences teams and health communicators. ### Sources * TIME Newsletters: [time.com/newsletters](/c/time-nl-health-2026q3/newsletters?i=b815acb3-95b3-473c-a4b3-6410c3aca10d&cr=time-nl-health-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 [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Apr 12, 2023 5:03 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 [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Apr 12, 2023 5:03 PM UTC Now that a Texas judge has ruled that the U.S. Food and Drug Administration (FDA)’s [approval of the abortion pill, mifepristone, is suspended](https://time.com/6269703/abortion-pill-mifepristone-fda-case/), what happens to the supply of the drug? The judge gave the Department of Justice (DOJ), which represents the FDA, until Apr. 14 to file an appeal before the suspension of the drug takes place. Both the DOJ and the drug’s maker, Danco, have filed appeals asking the Fifth Circuit Court to issue a stay on removing the drug’s approval. Making things more complicated, soon after the Texas judge’s ruling, a district court judge in Washington issued an opposing decision: that the FDA should keep mifepristone on the market and was prohibited from blocking access to the drug. That decision was in response to a lawsuit filed by attorneys general in 17 states and the District of Columbia who questioned the FDA’s requirement that doctors who prescribe mifepristone and pharmacies who dispense it be certified. If the appeals court does not grant a stay on the Texas judge’s decision in time, the drug would technically no longer be approved. But because no judge has called for the suspension of the FDA’s approval before, experts are divided over what that means for mifepristone. ## The FDA’s options Some think the FDA might have what’s called “enforcement discretion,” which legal experts are interpreting in different ways. Some believe this discretion allows the agency to decide not to enforce the judge’s order to suspend approval of the drug. In that case, the FDA would notify the manufacturer that it was providing safe harbor for the company to continue making and distributing the drug, says Sonia Suter, professor of law and director of the health law initiative at George Washington University. A [1985 Supreme Court decision](https://caselaw.findlaw.com/us-supreme-court/470/821.html) supports such an action, stating that the FDA has broad enforcement discretion. Others aren’t confident that the agency’s enforcement discretion applies in this situation, noting that it’s meant more for the FDA to modify its own rules and regulations when circumstances warrant. A recent example of such a situation occurred [in 2021](https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation#TheMifepristoneREMSProgram), when the FDA removed the restriction on mifepristone that required patients to get the medication in person from a certified health care provider. ## What happens to mifepristone that’s already in clinics and doctors’ offices? Doctors and clinics that currently have supplies of the drug will be looking to the FDA to determine what they do with their doses. But there is no precedent for what happens to drugs when it’s not the FDA—but a judge—that decides they are no longer approved. If the agency does follow the judge’s ruling and declares mifepristone no longer an approved drug, then “it is technically unlawful to prescribe or dispense a drug that isn’t authorized or approved by the FDA,” says Lawrence Gostin, director of the World Health Organization Collaborating Center on Public Health Law & Human Rights at Georgetown Law. **Read More**: [_Why Republicans Are Overreaching So Hard in So Many States_](https://time.com/6270498/republicans-red-states-abortion-culture-war/) But Kirsten Moore, director of the EMAA Project, an organization that helps expand access to medication abortion, believes doses already in the hands of health care providers could still be prescribed and dispensed. Because the Texas judge did not specify any action that the FDA had to take, such as removing the drug from the market, she says, those doses could be used. She points to a precedent from a recent FDA decision to [withdraw approval](https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information) of Makena, a drug that prevents premature birth, based on additional evidence that the medication wasn’t effective. In revoking its approval, the agency said “some health care providers might continue to prescribe or administer that limited remaining supply to their patients,” although the FDA urged doctors to consider the agency’s decision that the risks outweighed the benefits of doing so. “The Makena example gives us some information that once a drug is in interstate commerce, it’s considered still there,” says Moore. Removing a drug from the market is a highly regulated process that is laid out in the FDA’s statute. It requires the FDA commissioner and the Secretary of Health and Human Services to issue withdrawal notices, provide the reasons for the withdrawal, and give the manufacturer time to respond to those reasons. Having a judge suspend approval of a drug “is not what the statue requires for withdrawal of a drug,” says Suter. “It’s not the right process.” ## Access to mifepristone may depend on what state you live in Some states are not taking any chances on what might happen to the availability of mifepristone, which is used not just for abortions but also to manage miscarriages. Massachusetts has already [ordered 15,000 doses](https://www.mass.gov/news/governor-healey-announces-immediate-action-to-protect-access-to-medication-abortion-in-massachusetts) of mifepristone, enough to treat a typical number of patients in the state for a year. California has [purchased 2 million pills](https://www.gov.ca.gov/2023/04/10/california-announces-emergency-stockpile-of-abortion-medication-defending-against-extreme-texas-court-ruling/) of misoprostol, an FDA-approved drug for treating ulcers that is used off-label to induce abortions early in pregnancy in combination with mifepristone. Used alone, it can also induce an abortion, although it causes more side effects and the two medications together are more effective. Misoprostol [is poised to become the backup plan for medication abortions](https://time.com/6270258/texas-abortion-pill-ruling-mifepristone/) as the courts continue to debate the status of mifepristone. In the 18 jurisdictions affected by the Washington ruling, says Suter, doctors may have more confidence in continuing to prescribe mifepristone even if the appeals court does not issue a stay on the Texas judge’s decision. “Doctors could be bold and think, ‘I have one authority supporting me to continue prescribing the drug, so I will risk it,’” says Suter. “Or they could be conservative and decide it’s too confusing and switch to the alternative of misoprostol.” Given the uncertainty, many providers may err on the side of caution and be more reluctant to prescribe mifepristone for fear of being sued or losing their license if their state licensing boards view the abortion pills as an unapproved drug. ## Can you order mifepristone online? Online access to abortion pills may also be narrowing. In his ruling, the Texas judge invoked the [Comstock Act](https://www.justice.gov/olc/opinion/file/1560596/download), an 1873 law that prohibits sending any “instrument, substance, drug, medicine or thing” that could be used for abortion. In a 2022 opinion, however, the DOJ [clarified](https://www.justice.gov/olc/opinion/file/1560596/download) that it was not illegal to send abortion medications by mail as long as the sender “lacks the intent that the recipient of the drugs will use them unlawfully.” Still, in his ruling, the Texas judge cited Comstock with a strict reading of “intent,” opening up the possibility that sending mifepristone by mail to any state, regardless of whether the state bans or allows abortion, would be illegal. **Read More**: [_What Nine Months Means to a Pregnant Person_](https://time.com/6265098/abortion-alabama-clinic-nine-months-after-dobbs/) That could make medication abortion less convenient for everyone, even for those in states where abortion is legal. People in those states can currently have a telehealth visit and get a prescription sent to a mail-order pharmacy and then delivered to their home, but soon they may now have to go in person to obtain the pills, since mailing them could be illegal. U.S. residents could still order mifepristone from overseas, since the Comstock Act does not apply to non-U.S. providers. [Aid Access](https://aidaccess.org/en/), a Europe-based provider of abortion pills, [ships medications from abroad](https://time.com/collection/100-most-influential-people-2020/5888177/rebecca-gomperts/) for those who live in states where abortion is banned, and from U.S. sites for those who live in states where abortion is allowed. While current abortion laws in states only criminalize providers of abortion in the U.S., if current anti-abortion political and judicial pressures continue, Suter says “the next move would be to criminalize the behavior of the patient.” Already, she says, prosecutors in some states have gotten creative with their tactics, including by using child abuse and neglect laws, to hold women who use self-induced abortions accountable. For now, health providers and legal scholars are waiting for the decision of the appeals court to determine how the right to medication abortions will change. Many states and health providers were [turning to abortion pills as a solution](https://time.com/6181162/abortion-pill-access-roe-v-wade/) to the narrowing availability of abortion procedures in U.S. states; for women who don’t have easy access to surgical abortions, the combination of mifepristone and misoprostol provided a safe and reliable alternative. “Mifepristone was something that was going to help relieve some pressure on clinics in states where abortion is still legal, because those clinics were seeing a big influx of patients from states where abortion is banned,” says Liz Borkowski, managing director of the Jacobs Institute of Women’s Health at the Milken Institute School of Public Health of George Washington University. “We were hoping access was about to improve in states where abortion is legal. But this could actually reverse that.” ## 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/6270733/abortion-pill-ruling-fda-explained/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6270733/abortion-pill-ruling-fda-explained/"},"headline":"What Happens Next in the Fight Over Abortion Pills","datePublished":"2023-04-12T17:03:07.000Z","dateModified":"2026-10-19T07:15:07.105Z","description":"Here’s how the supply of abortion pills may change after a Texas judge's ruling on mifepristone.","url":"https://time.com/6270733/abortion-pill-ruling-fda-explained/","keywords":["abortion","healthscienceclimate"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blt859822cec5dbc37d/698a3bee16d8847642c3bb9d/mifepristone-abortion-pill-supply.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Alice Park","jobTitle":"Senior Correspondent","url":"https://time.com/author/alice-park/"}],"articleSection":"Health","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/blt859822cec5dbc37d/698a3bee16d8847642c3bb9d/mifepristone-abortion-pill-supply.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023","caption":"Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023","creditText":"Evelyn Hockstein—Reuters","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":"/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"/tag/abortion/","name":"abortion"}},{"@type":"ListItem","position":3,"item":{"@id":"https://time.com/6270733/abortion-pill-ruling-fda-explained/","name":"What Happens Next in the Fight Over Abortion Pills"}}]},{"@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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