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FDA v. Alliance for Hippocratic Medicine

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571:—issued an order regarding the stay motion. In a 2–1 decision, it partially stayed Judge Kacsmaryk's order by allowing the FDA's original 2000 approval of mifepristone to stand, ruling that too much time had passed to challenge the ruling. However, the order did not stay Kacsmaryk's order insofar as it struck down hold changes to the REMS for mifepristone issued by the FDA in 2016 that had made the drug easier to obtain, including through the mail, and extended the allowed use of the drug from seven to ten weeks of pregnancy. The opinion stated that "it would be difficult for to argue that" the 2016 changes to the REMS "were so critical to the public given that the Nation operated—and mifepristone was administered to millions of women—without them for sixteen years following the" original approval, and thus that that was no reason to put them on hold. Judge Haynes noted that she would grant an administrative stay of Kacsmaryk's order in full. 36: 788:
who suffered complications from using mifepristone were also rejected, as Kavanaugh wrote "Federal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences — and therefore breaks any chain of causation between FDA’s relaxed regulation of mifepristone and any asserted conscience injuries to the doctors." He also stated that doctors "have never had standing to challenge FDA drug approvals simply on the theory that use of the drug by
300:, the Fifth Circuit partially reverted Kacsmaryk's injunction, allowing the drug's 2000 approval to stand, but putting on hold changes to the FDA's distribution rules on the drug that were put in place in 2016, including distribution by mail. A separate Washington federal district judge also issued on April 7, 2023, a separate injunction forcing the FDA to maintain the distribution of mifepristone in 16 states and the District of Columbia. On April 13, that judge issued 801:. Association standing allows for an association representing members of a class with standing to bring the case to court. Thomas stated that this concept may be unconstitutional that should be reviewed in a more appropriate case. He wrote, "If a single member of an association has suffered an injury, our doctrine permits that association to seek relief for its entire membership - even if the association has tens of millions of other, non-injured members." 772:
Oral arguments were held on March 26, 2024. Court observers found the a majority of the justices appeared to support the FDA's assertion that the Alliance lacked standing to challenge the law, a view taken by the three more-liberal justices Kagan, Sotomayor, and Jackson, joined by Gorsuch, Kavanaugh, and Barrett. Justices Alito and Thomas were seen to support that there was standing and asked questions related to the rationale for overriding the FDA.
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represented some doctors to whom the injured women and girls might turn; that this would harm the doctors who had to care for those patients; and that that harm to the doctors was "sufficiently imminent" and there was a "'substantial risk' that the harm will occur". As the organizations were doctors' groups, he also ruled that they had
680:. Kacsmaryk is a "devout Christian" and reliably conservative judge, who has struck down several Biden administration policies on issues of immigration, LGBT rights, and abortion. AHM filed the case in Amarillo, Texas, which belongs to the Amarillo Division, where Kacsmaryk is the only judge, leading to accusations of " 787:
Justice Brett Kavanaugh wrote the opinion, stating that while the Alliance may have moral and policy concerns on mifepristone, because they did not prescribe mifepristone, they failed to demonstrate a legally cognizable injury to challenge its use. The Alliance's claims that it might treat patients
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Both the FDA and Danco petitioned to the Supreme Court to challenge the Fifth Circuit's ruling. The court certified both petitions, consolidated under the FDA's challenge, and limited the case to the question of standing, and of the appropriateness of the FDA rule changes in 2016, 2021, and, 2023.
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of mifepristone, stated that, should the FDA be forced to remove mifepristone from the market, it would need to go through certain procedural requirements to reverse their prior approval of the drug, or otherwise GenBioPro's product would be mislabeled on the market. Legal experts were unclear how
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Kacsmaryk had written that women who went through abortions "often experience shame, regret, anxiety, depression, drug abuse, and suicidal thoughts because of the abortion", but did not cite any studies reporting the opposite. One study highlighting mental issues stemming from abortion, as well as
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In March 2016, the FDA loosened safety precautions present in the original approval, allowing medical practitioners to also prescribe the drug, and increased the time into the pregnancy term when the drug could be used. In April 2021, in response to the lack of access to medical care caused by the
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to sue—the legal right to bring a case before a judge. He held that because mifepristone can cause serious complications to pregnant women and girls, they might need to go to a doctor for treatment; that abortion providers generally do not treat such cases; that the associations bringing the case
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In his ruling, Kacsmaryk cited a Finnish study that the "overall incidence of adverse events is 'fourfold higher' in chemical abortions when compared to surgical abortions", but one of the study's authors, gynecology professor Oskari Heikinheimo, disagreed with how Kacsmaryk portrayed the study;
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for having incomplete data. The American Psychological Association instead reported: "Large longitudinal and international studies have found that obtaining a wanted abortion does not increase risk for depression, anxiety, or suicidal thoughts." Kacsmaryk did not discuss potential psychological
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scientific ways." In describing the action of the pill, he said that mifepristone is used to "to kill the unborn human" and that it "ultimately starves the unborn human until death." Kacsmaryk also referred to doctors who provide abortion pills as "abortionists," and called medication abortion
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of the Eastern District of Washington, ruled in a separate lawsuit that the FDA should refrain from any actions to reduce the availability of the drug in 16 states and the District of Columbia. The Washington lawsuit had been raised due to changes in the REMS for mifepristone in January 2023,
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The lead plaintiff, the Alliance for Hippocratic Medicine (AHM), describes itself as "uphold and promot the fundamental principles of Hippocratic medicine", which "include protecting the vulnerable at the beginning and end of life." AHM was incorporated in August 2022 and is headquartered in
519:—which would normally have started in 2016, when one of the plaintiff's review petitions was rejected—was "reopened" in 2016 and again in 2021, when the FDA increased access to the drug. He finally ruled that the approval of mifepristone was "otherwise not in accordance with law"—citing the 629:, ruled on August 16, 2023, to maintain the ban on mifepristone's availability that had come about from the 2016 FDA rule changes, ruling the FDA did not properly consider health factors in that decision. The ban remained on hold with the federal government appealing the decision to the 367:, the FDA allowed mifepristone to be obtained by mail from certified medical businesses and practitioners, which greatly increased access to the drug. Another REMS change was made in January 2023, allowing pharmacies approved by mifepristone manufacturers to also distribute the drug. 817:, which establishes procedures for the federal courts, established a new rule that challenges to state or federal laws with national impacts filed within federal districts would be randomly assigned to a judge within the entire district, aiming to prevent aggressive judge shopping. 495:. Ahead of an in-person hearing on the case, Kacsmaryk delayed entering the hearing on the court docket, citing concerns about potential protests over the hearing. After this information was leaked, the date was posted and the hearing took place as scheduled, on March 15, 2023. 359:(REMS) to identify the benefits and risks of any approved drug and give the FDA more control over adjusting their approvals of drugs. By the time the FDA completed the REMS for mifepristone in 2011, it kept the same limits on access at hospitals and other medical facilities. 538:
that claimed there was potential harm to the woman when taking milepristone. Sage retracted these two papers in February 2024 over two issues. First, they stated that their primary author, James Studnicki of the Charlotte Lozier Institute, itself the research branch of the
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or significant record), stating: "I did not agree with these criticisms at the time, but if they were warranted in the cases in which they were made, they are emphatically true here" in this lawsuit. Alito added that his dissent did not analyze the merits of the lawsuit.
600:, in which he argued that, even if the Supreme Court restricted access to mifepristone, the FDA could refuse to enforce that decision and continue allowing access to mifepristone while the lawsuit continued. Alito also referred to previous lawsuits' criticisms of the ' 346:
Under the 2000 approval, mifepristone was approved by the FDA under Congressional regulations granted to them by Subpart H of the FDA's mandate. This included restricted distribution of mifepristone through hospitals and other medical facilities. With passage of the
301: 718:, and also "cites research based on anonymous blog posts, cherry picks statistics that exaggerate the negative physical and psychological effects of mifepristone, and ignores hundreds of scientific studies attesting to the medication's safety." 543:
organization, did not properly cite his potential conflict of interest in performing the studies. Second, Sage found from a second independent review of the works that there were "fundamental problems" with the studies' approach.
412:—in addition to four doctors. The plaintiffs argued that the FDA did not properly consider all evidence at the time of the 2000 approval of mifepristone, and sought relief by having the court revoke the FDA's approval. 752:
restricting the previously open access of the drug. The states argued that not only was the January 2023 REMS change too restrictive, but other parts of the current REMS were unnecessary and should be lifted.
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enacted a temporary administrative stay on the District Court's decision while the Supreme Court considered the case. Alito originally set the stay to last until April 19, then later extended it to April 21.
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On April 21, 2023, a majority of the Supreme Court, without comment, voted to stay the lower court decisions that would restrict access to mifepristone, pending the decision of the Fifth Circuit on the
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and held that there was no constitutional right to abortion, which enabled states to ban abortion. In order to restrict abortions, several states also passed laws to prevent the sale of mifepristone.
669:(D–WA), cautioned that the government should allow the appeals process to proceed before taking any action to avoid risking the judicial process. Some Republicans praised the decision, like Senator 755:
Following the Fifth Circuit's April 12 ruling, Judge Rice declared in a new order that the Fifth Circuit's stay decision does not override his order for D.C. and the 16 state-parties in his case.
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to bring a case, since neither AHM nor the groups it represented had shown injury. The decision reversed the lower court decisions, restoring mifepristone's availability under current FDA rules.
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procedures. The plaintiffs, led by the Alliance for Hippocratic Medicine (AHM), argued that the FDA did not properly approve the use of the drug mifepristone for pregnancy termination under
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case are Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Nevada, New Mexico, Rhode Island, Vermont, D.C., Hawaii, Maine, Maryland, Minnesota, and Pennsylvania.
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Thomas wrote a concurring option that agreed that the Alliance did not have standing, but also challenged the concept of association standing that was argued, based on the 1977 case
797: 726:, an anti-abortion website run by the Institute of Reproductive Grief Care. Another study that was cited by Kacsmaryk regarding suicide after abortion had been criticized by the 91: 553: 460: 348: 2071: 579:
Both the Justice Department and Danco Laboratories appealed the restrictions on mifepristone to the Supreme Court on April 14, 2023. Later that day, Supreme Court Justice
2111: 527:—and ordered the FDA to suspend the drug's approval until a later date. He then stayed his own order for seven days to allow the government time to appeal his decision. 2233: 1784: 919: 758:
A separate lawsuit was filed by GenBioPro against the FDA shortly after the FDA had sought a stay on the Fifth Circuit's decision. GenBioPro, the manufacturers of the
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Heikinheimo stated that the same study showed that serious complications were remarkably low for both types of abortions, while most of the "adverse events" were
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and asserted there was no constitutional right to abortion at the federal level, leading conservative states and groups to further restrict abortion access.
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regulations and asked for an injunction to withdraw the drug's approval, thus removing it from the market. AHM's suit followed the Supreme Court's ruling in
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Medication abortion, in which prescription medications are used to induce abortion of the embryo, typically occurs with a mixture of two different drugs—
2389: 1652: 1431: 1136: 1082: 1582: 1561: 1408: 1986: 813:, filed within a specific division of the district as to have the case likely assigned to a specific judge from that division. On March 12, 2024, the 409: 404:. Other plaintiffs include three out-of-state anti-abortion groups—the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), the 356: 1196:
Kortsmith, Katherine; Nguyen, Antoinette T.; Mandel, Michele G.; Clark, Elizabeth; Hollier, Lisa M.; Rodenhizer, Jessica; Whiteman, Maura K. (2022).
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The case was put on an accelerated schedule, with the Fifth Circuit holding oral arguments on May 17. The Fifth Circuit panel, consisting of judges
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wrote that Kacsmaryk's ruling "strays from offering accurate health information from some of the largest medical organizations in the nation".
2273: 1817: 1366: 1326: 2784: 2676: 2562: 2092: 1202: 2207: 352: 274: 2309: 2009: 1452: 661:(D–NY), called for the Biden administration to ignore the ruling and continue to distribute mifepristone, while others, such as Senators 2663:
Grossi, Peter, O'Connor, D. (2023) "FDA preemption of conflicting state drug regulation and the looming battle over abortion medications
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standing to challenge the FDA's approval or rule making. The decision reversed the Fifth Circuit ruling and lifted the injunction.
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On April 7, 2023, Kacsmaryk issued his opinion finding primarily in favor of the plaintiffs, and issued an order granting AHM's
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issued a preliminary injunction suspending the approval of mifepristone on April 7, 2023; on appeal by the government to the
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Intervenor Danco Laboratories and the federal defendants filed separate appeals to the Supreme Court. The cases are
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described Kacsmaryk's ruling as repeatedly citing data collected from researchers affiliated with the anti-abortion
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The Texas lower court decision has been widely criticized by Democratic politicians, such as House minority leader
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On April 10, 2023, the Department of Justice and Danco Laboratories filed an emergency motion for a stay with the
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of the lawsuit, and a potential appeal of that decision. How every justice voted was not detailed, but Justices
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women receiving "insufficient information" on abortion, had its data collected from anonymous blog posts from
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https://www.reuters.com/legal/supreme-courts-thomas-questions-ability-groups-challenge-us-laws-2024-06-13/
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and Alito publicly dissented, wanting to approve the restrictions. Alito was the only justice to write a
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Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone.
2176: 1541: 622: 222: 86: 1367:"In Texas lawsuit seeking to reverse FDA approval of abortion pills, state attorneys general weigh in" 1882: 1587: 508: 492: 293: 2451:"Generic abortion pill maker GenBioPro sues FDA over its response to orders halting drug's approval" 2630: 2278: 2238: 1753: 1336: 710: 424: 2701: 2643: 1785:"Supreme Court says abortion pill mifepristone will remain broadly available during legal battle" 1457: 1004: 923: 687:
Media outlets noted that Kacsmaryk's opinion contained several instances of language employed by
597: 564: 471: 467: 452: 304:, purporting to force FDA to maintain approval regardless of the Texas or Fifth Circuit ruling. 1932:"Appeals court imposes restrictions on abortion pill, but drug will stay on the market for now" 2744: 2693: 2656: 2652: 1545: 1237: 1219: 1109:"The Supreme Court will decide the future of the abortion pill. A timeline of how we got here" 996: 988: 364: 214: 2093:"Meet the federal judge set to rule in a case that could disrupt access to the abortion pill" 2734: 2726: 2685: 2342: 1566: 1520: 1227: 1211: 980: 736: 676:
Attention was drawn to Judge Kacsmaryk, who was nominated to the bench in 2017 by President
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Kacsmaryk's opinion relied heavily on two scientific studies that had been published in the
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76 (forthcoming 2024), University of Pittsburgh Legal Studies Research Paper No. 2023-12,
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The court issued its unanimous decision on June 13, 2024, ruling that the Alliance lacked
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FDA v. Alliance for Hippocratic Medicine was consolidated with the simultaneous petition
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The original case, filed on the Northern District of Texas, was considered an example of
502:, suspending the FDA's approval of the drug. He first concluded that the plaintiffs have 2072:"How an obscure Christian right activist became one of the most powerful men in America" 691:. He deliberately chose to use the terms "unborn human" and "unborn child" in place of " 2739: 2714: 2477:"Supreme Court seems likely to preserve access to the abortion medication mifepristone" 1754:"Supreme Court extends order preserving access to abortion pill mifepristone to Friday" 1232: 810: 748: 681: 650: 626: 503: 463: 444: 312: 137:
Whether respondents have Article III standing to challenge FDA's 2016 and 2021 actions.
1197: 2778: 2705: 2076: 1331: 1257:"A federal judge could soon block access to an abortion pill. Here's what that means" 1141: 1008: 662: 605: 601: 568: 524: 440: 297: 2432:"Federal court rules 17 states, D.C. are not impacted by Texas abortion pill ruling" 1474:"What to know about the lawsuit aiming to ban medication abortion drug mifepristone" 261:, 602 U.S. 367 (2024), was a United States Supreme Court case to challenge the U.S. 2531:
https://www.courthousenews.com/supreme-court-throws-out-challenge-to-abortion-pill/
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Weber, Lauren; McGinley, Laurie; Ovalle, David; Sellers, Frances (April 13, 2023).
2116: 1499: 1158:"How the judge who could ban the abortion pill won confirmation in the U.S. Senate" 759: 677: 666: 580: 520: 328: 266: 202: 186: 170: 1878:"Supreme Court pauses abortion pill restrictions from taking effect during appeal" 1653:"Court Says Abortion Pill Can Remain Available but Imposes Temporary Restrictions" 684:", where plaintiffs select legal venues most likely to deliver favorable rulings. 2576:"Federal courts make it harder to 'judge-shop' as was done in abortion pill case" 1676:"Appeals court preserves partial access to abortion pill, but with tighter rules" 1728:"Supreme Court Justice Alito issues administrative stay of abortion pill ruling" 1409:"12 States Sue F.D.A., Seeking Removal of Special Restrictions on Abortion Pill" 618: 589: 382: 332: 285: 198: 2629:
Cohen, David S., Donley, Greer, and Rebouché, Rachel (2023). "Abortion Pills".
1495:"Access to abortion pill in the balance as Texas judge hears mifepristone case" 958: 559:
Late on April 12, 2023, a three-judge panel of the Fifth Circuit—consisting of
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ruled unanimously on June 13, 2024 that the Alliance did not have association
2602:"Republicans will no longer get to handpick their judges when they sue Biden" 2010:"Ignore the courts? Some Democrats say Texas abortion pill ruling demands it" 1223: 992: 1327:"The Shadow Medical Community Behind the Attempt to Ban Medication Abortion" 1064:"Medical Groups Ask FDA To Ease Access To Abortion Pill During The Pandemic" 654: 2748: 2697: 1241: 1215: 1000: 339:(FDA) in September 2000. Medication abortion accounts for over half of all 2730: 1844:"Here's what the Supreme Court abortion pill ruling means and what's next" 2509: 2371:"Rival rulings on medication abortion hypercharge the post-Roe legal war" 2014: 1758: 1371: 1261: 984: 103: 2689: 2481: 1961: 1583:"Journal publisher retracts abortion pill studies cited by Texas judge" 1560:
Weber, Paul J.; Perrone, Matthew; Lindsay, Whitehurst (April 8, 2023).
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Zettler, Patricia J.; Adashi, Eli Y.; Cohen, I. Glenn (March 9, 2023).
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Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration
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Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration
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Court case challenging the legality of medication abortion in the U.S.
2390:"Judge Invalidates F.D.A. Approval of the Abortion Pill Mifepristone" 415:
The plaintiffs are represented by the Christian legal advocacy group
2634: 2310:"'Unborn human': the anti-abortion rhetoric of Texas judge's ruling" 2143:"'Unborn human': the anti-abortion rhetoric of Texas judge's ruling" 920:"Where Restrictions on Abortion Pills Could Matter Most in the U.S." 1987:"Reaction to Texas Abortion Pill Ruling: Outrage, and Muted Praise" 1634:"DOJ asks appeals court for emergency stay of abortion pill ruling" 1045:"Legal Challenges to the FDA Approval of Medication Abortion Pills" 1904:
Marimow, Ann E; Kitchener, Caroline; Stein, Perry (May 17, 2023).
1137:"Abortion Providers Gear Up for Judge's Ruling Over Pill Approval" 1043:
Sobel, Laurie; Salganicoff, Alina; Felix, Mabel (March 13, 2023).
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Whether FDA's 2016 and 2021 actions were arbitrary and capricious.
2112:"The Legal Decision That Could Rewrite the Abortion Battle—Again" 882:
Food and Drug Administration v. Alliance for Hippocratic Medicine
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Food and Drug Administration v. Alliance for Hippocratic Medicine
2544:"Supreme Court rejects challenge to abortion pill accessibility" 1392: 2505:"Supreme Court rejects bid to restrict access to abortion pill" 1842:
Stein, Perry; Amber, Phillips; Ovalle, David (April 21, 2023).
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Franchise Tax Account Status, Alliance for Hippocratic Medicine
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Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine
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United States District Court for the Northern District of Texas
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Whether the district court properly granted preliminary relief.
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Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine
2759:. Legal analysis of the Texas District Court initial opinion ( 2548: 2314: 1478: 1113: 1083:"F.D.A. Will Allow Abortion Pills by Mail During the Pandemic" 1028: 1024:"A Drug That Eases Miscarriages Is Difficult For Women To Get" 731:
effects for women who wanted an abortion and were denied one.
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GenBioPro's lawsuit would interact with the two other suits.
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Unikowsky, Adam (2023). "Mifepristone and the rule of law".
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Donley, Greer (2022). "Medication Abortion Exceptionalism".
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Danco Laboratories, LLC v. Alliance for Hippocratic Medicine
1278:"Medication abortions are under fire: Here's how they work" 2051:
Kitchener, Caroline; Marimow, Ann E. (February 25, 2023).
1562:"Access to abortion pill in limbo after competing rulings" 470:, the manufacturer of brand-name mifepristone (Mifeprex), 1818:"Supreme Court preserves access to abortion pill for now" 918:
McCann, Allison; Walker, Amy Schoenfeld (March 2, 2023).
2715:"Mifepristone, preemption, and public health federalism" 2031:"Dueling Decisions Leave Abortion Pill's Fate Uncertain" 967:
s Collateral Consequences for Pharmaceutical Regulation"
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All. for Hippocratic Med. v. U.S. Food & Drug Admin.
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Rebouché, Rachel (2022). "Remote Reproductive Rights".
2053:"The Texas judge who could take down the abortion pill" 1876:
Schnonfield, Zach; Weixel, Nathaniel (April 21, 2023).
1177:"Medication Abortion: New Litigation May Affect Access" 556:, asking the court to stay the district court's order. 2790:
United States Supreme Court cases of the Roberts Court
2338:"Texas judge's rationale on abortion misses the truth" 62:, et al.; v. Alliance for Hippocratic Medicine, et al. 1352:. Texas Office of the Comptroller. December 22, 2022. 1135:
Castronuovo, Celine; Lopez, Ian (February 10, 2023).
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Hunt v. Washington State Apple Advertising Commission
1611:"Here's What Happens Next in the Abortion Pill Case" 1276:
Tanner, Lindsey; Perrone, Matthew (March 15, 2023).
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United States Court of Appeals for the Fifth Circuit
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Health Services Research and Managerial Epidemiology
2046: 2044: 1632:Mallin, Alexander; Cathey, Libby (April 10, 2023). 1537:"Two (Wrong) Mifepristone Court Rulings in One Day" 942:
FDA Approval Memorandum re: Mifeprex (mifepristone)
673:(R–MS), although there were not as many responses. 349:
Food and Drug Administration Amendments Act of 2007
246: 235: 230: 159: 149: 129: 114: 109: 99: 81: 67: 54: 47: 26: 2763:) and the Fifth Circuit's emergency stay opinion ( 1320: 1318: 1022:Gordon, Mara; McCammon, Sarah (January 10, 2019). 2411:VanSickle, Abbie; Belluck, Pam (April 8, 2023). 2206:Atkins, Chloe; Arkin, Daniel (April 11, 2023). 1985:Astor, Maggie; Chen, David W. (April 7, 2023). 1674:Weber, Paul; Gresko, Jessica (April 13, 2023). 1102: 1100: 1609:Belluck, Pam; Liptak, Adam (April 12, 2023). 1198:"Abortion Surveillance — United States, 2020" 880:, No. 22A901 (U.S. filed April 14, 2023) and 8: 1980: 1978: 747:Within an hour of Kacsmaryk's ruling, Judge 377:Dobbs v. Jackson Women's Health Organization 280:Dobbs v. Jackson Women's Health Organization 419:(ADF). The ADF drafted the law at issue in 2713:Zettler, Patricia J.; et al. (2022). 1811: 1809: 1807: 1805: 1778: 1776: 23: 2738: 2267: 2265: 2263: 2261: 2137: 2135: 2133: 2131: 2029:Brown, Elizabeth Nolan (April 10, 2023). 2008:Ollstein, Alice Maranda (April 8, 2023). 1871: 1869: 1360: 1358: 1231: 1175:Staman, Jennifer A. (February 14, 2023). 884:, No. 22A902 (U.S. filed April 14, 2023). 523:'s prohibition on interstate shipment of 410:Christian Medical and Dental Associations 357:Risk Evaluation and Mitigation Strategies 2303: 2301: 2201: 2199: 961:Alliance for Hippocratic Medicine v. FDA 815:Judicial Conference of the United States 27:FDA v. Alliance for Hippocratic Medicine 2170: 2168: 2166: 2164: 952: 950: 910: 826: 457:Department of Health and Human Services 449:Center for Drug Evaluation and Research 2795:Political history of the United States 2677:American Journal of Law & Medicine 2177:"Ruling echoes anti-abortion rhetoric" 1581:Weixel, Nathanial (February 6, 2024). 792:may cause more visits to the doctor." 483:Texas District Court opinion and order 2820:Alliance Defending Freedom litigation 2805:United States administrative case law 2232:Kitchener, Caroline (April 8, 2023). 1430:Pierson, Brendan (January 17, 2023). 1386:Kimball, Spencer (January 24, 2023). 1203:Morbidity and Mortality Weekly Report 435:The original defendants are the FDA, 21:2024 United States Supreme Court case 7: 2336:Bartlett, Jessica (April 11, 2023). 2070:Millhiser, Ian (December 17, 2022). 1930:Kimball, Spencer (August 16, 2023). 1535:Adler, Jonathan H. (April 8, 2023). 1514:Stern, Mark Joseph (April 7, 2023). 1255:Luthra, Shefali (February 7, 2023). 850:, No. 2:22-cv-00223, ECF No. 1, at 1 443:, Principal Deputy Commissioner Dr. 353:Federal Food, Drug, and Cosmetic Act 275:Federal Food, Drug, and Cosmetic Act 2669:https://doi.org/10.1093/jlb/lsad005 2574:Hurley, Lawrence (March 12, 2024). 2430:Gonzalez, Oriana (April 13, 2023). 2308:de Vogue, Ariane (April 12, 2023). 2110:Fattal, Isabel (February 8, 2023). 1956:Chung, Andrew (September 8, 2023). 1783:Kimball, Spencer (April 21, 2023). 1700:Kimball, Spencer (April 14, 2023). 1365:Atkins, Chloe (February 10, 2023). 1325:Smith, Jordan (February 28, 2023). 1298:"Alliance for Hippocratic Medicine" 575:Supreme Court emergency stay ruling 548:Fifth Circuit emergency stay ruling 335:. Mifepristone was approved by the 2719:Journal of Law and the Biosciences 2665:Journal of Law and the Biosciences 2503:Hurley, Lawrence (June 13, 2024). 1493:Nowell, Cecilia (March 15, 2023). 1451:Perez, Andrew (February 6, 2023). 1407:Belluck, Pam (February 24, 2023). 728:American Psychological Association 355:was amended to require the use of 309:Supreme Court of the United States 41:Supreme Court of the United States 14: 2600:Millhiser, Ian (March 12, 2024). 2542:Totenberg, Nina (June 13, 2024). 2449:Snead, Tierney (April 19, 2023). 1752:Quinn, Melissa (April 19, 2022). 1302:Alliance for Hippocratic Medicine 1156:Shutt, Jennifer (March 1, 2023). 541:Susan B. Anthony Pro-Life America 406:American College of Pediatricians 2475:Sherman, Mark (March 26, 2024). 2369:Sneed, Tierney (April 8, 2023). 2091:Quinn, Melissa (March 2, 2023). 1816:Sherman, Mark (April 22, 2023). 1107:Choi, Annette (March 25, 2024). 1062:McCammon, Sarah (May 27, 2020). 511:. Kacsmaryk then ruled that the 34: 2800:United States abortion case law 1726:Dwyer, Devin (April 15, 2023). 1651:Belluck, Pam (April 13, 2023). 1081:Belluck, Pam (April 13, 2021). 972:New England Journal of Medicine 2815:2024 in United States case law 2810:2023 in United States case law 2388:Belluck, Pam (April 7, 2023). 1472:Cole, Devan (March 13, 2023). 1182:Congressional Research Service 437:Commissioner of Food and Drugs 341:abortions in the United States 1: 2175:Reed, Tina (April 10, 2023). 647:Democratic National Committee 604:' (emergency rulings with no 2785:Food and Drug Administration 513:Administrative Procedure Act 337:Food and Drug Administration 269:, a drug frequently used in 263:Food and Drug Administration 60:Food and Drug Administration 852:(N.D. Texas April 7, 2023). 631:United States Supreme Court 466:. Later on in the lawsuit, 372:United States Supreme Court 2836: 1049:KFF: Women's Health Policy 944:. FDA. September 28, 2000. 867:(5th Cir. April 10, 2023). 865:, No. 23-10362, ECF No. 20 716:Charlotte Lozier Institute 653:. Some, including Senator 487:The case was filed in the 417:Alliance Defending Freedom 893:The state parties in the 657:(D–OR) and Congresswoman 164: 154: 134: 33: 659:Alexandria Ocasio-Cortez 283:in 2022, which reversed 689:anti-abortion movements 509:organizational standing 1216:10.15585/mmwr.ss7110a1 724:abortionchangesyou.com 517:statute of limitations 500:preliminary injunction 1542:The Volokh Conspiracy 1419:on February 25, 2023. 1339:on February 28, 2023. 700:"chemical abortion." 623:Jennifer Walker Elrod 613:Fifth Circuit hearing 239:Kavanaugh, joined by 223:Ketanji Brown Jackson 50:Decided June 13, 2024 48:Argued March 26, 2024 2124:on February 9, 2023. 985:10.1056/NEJMp2301813 493:Matthew J. Kacsmaryk 294:Matthew J. Kacsmaryk 265:(FDA)'s approval of 2731:10.1093/jlb/lsac037 2690:10.1017/amj.2022.29 2631:Stanford Law Review 2279:The Washington Post 2239:The Washington Post 2057:The Washington Post 1910:The Washington Post 1848:The Washington Post 711:The Washington Post 491:and heard by Judge 425:Gestational Age Act 130:Questions presented 2644:Cornell Law Review 2417:The New York Times 2394:The New York Times 1991:The New York Times 1663:on April 13, 2023. 1657:The New York Times 1621:on April 12, 2023. 1615:The New York Times 1413:The New York Times 1162:Wisconsin Examiner 1093:on April 14, 2021. 1087:The New York Times 924:The New York Times 598:dissenting opinion 565:Kurt D. Engelhardt 468:Danco Laboratories 453:Patrizia Cavazzoni 447:, Director of the 380:, which overruled 370:In June 2022, the 175:Associate Justices 2400:on April 7, 2023. 2350:on April 11, 2023 2286:on April 13, 2023 1997:on April 8, 2023. 1854:on April 22, 2023 931:on March 2, 2023. 365:COVID-19 pandemic 254: 253: 215:Amy Coney Barrett 2827: 2752: 2742: 2709: 2684:(2–3): 244–255. 2660: 2617: 2616: 2614: 2612: 2597: 2591: 2590: 2588: 2586: 2571: 2565: 2560: 2554: 2553: 2539: 2533: 2528: 2522: 2521: 2519: 2517: 2500: 2494: 2493: 2491: 2489: 2472: 2466: 2465: 2463: 2461: 2446: 2440: 2439: 2427: 2421: 2420: 2408: 2402: 2401: 2396:. Archived from 2385: 2379: 2378: 2366: 2360: 2359: 2357: 2355: 2346:. Archived from 2343:The Boston Globe 2333: 2327: 2326: 2324: 2322: 2305: 2296: 2295: 2293: 2291: 2282:. Archived from 2269: 2256: 2255: 2253: 2251: 2246:on April 8, 2023 2242:. 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Archived from 915: 898: 891: 885: 874: 868: 859: 853: 844: 838: 837:, Docket 23-236. 831: 737:uterine bleeding 671:Cindy Hyde-Smith 561:Catharina Haynes 423:, Mississippi's 271:medical abortion 160:Court membership 38: 37: 24: 2835: 2834: 2830: 2829: 2828: 2826: 2825: 2824: 2775: 2774: 2712: 2673: 2640: 2626: 2624:Further reading 2621: 2620: 2610: 2608: 2599: 2598: 2594: 2584: 2582: 2573: 2572: 2568: 2561: 2557: 2541: 2540: 2536: 2529: 2525: 2515: 2513: 2502: 2501: 2497: 2487: 2485: 2474: 2473: 2469: 2459: 2457: 2448: 2447: 2443: 2429: 2428: 2424: 2410: 2409: 2405: 2387: 2386: 2382: 2368: 2367: 2363: 2353: 2351: 2335: 2334: 2330: 2320: 2318: 2307: 2306: 2299: 2289: 2287: 2271: 2270: 2259: 2249: 2247: 2231: 2230: 2226: 2216: 2214: 2205: 2204: 2197: 2187: 2185: 2174: 2173: 2162: 2152: 2150: 2149:. 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Rice 744: 741: 682:forum shopping 651:Jaime Harrison 638: 635: 627:Cory T. Wilson 614: 611: 576: 573: 549: 546: 525:abortifacients 484: 481: 479: 476: 464:Xavier Becerra 445:Janet Woodcock 432: 429: 396: 393: 391: 388: 324: 321: 252: 251: 248: 244: 243: 237: 233: 232: 228: 227: 226: 225: 176: 173: 168: 162: 161: 157: 156: 152: 151: 147: 146: 145: 144: 141: 138: 132: 131: 127: 126: 116: 112: 111: 107: 106: 101: 97: 96: 83: 79: 78: 69: 65: 64: 56: 55:Full case name 52: 51: 45: 44: 39: 31: 30: 20: 15: 13: 10: 9: 6: 4: 3: 2: 2832: 2821: 2818: 2816: 2813: 2811: 2808: 2806: 2803: 2801: 2798: 2796: 2793: 2791: 2788: 2786: 2783: 2782: 2780: 2770: 2766: 2762: 2758: 2754: 2750: 2746: 2741: 2736: 2732: 2728: 2724: 2720: 2716: 2711: 2707: 2703: 2699: 2695: 2691: 2687: 2683: 2679: 2678: 2672: 2670: 2666: 2662: 2658: 2654: 2650: 2646: 2645: 2639: 2636: 2632: 2628: 2627: 2623: 2607: 2603: 2596: 2593: 2581: 2577: 2570: 2567: 2564: 2559: 2556: 2551: 2550: 2545: 2538: 2535: 2532: 2527: 2524: 2512: 2511: 2506: 2499: 2496: 2484: 2483: 2478: 2471: 2468: 2456: 2452: 2445: 2442: 2437: 2433: 2426: 2423: 2418: 2414: 2407: 2404: 2399: 2395: 2391: 2384: 2381: 2376: 2372: 2365: 2362: 2349: 2345: 2344: 2339: 2332: 2329: 2317: 2316: 2311: 2304: 2302: 2298: 2285: 2281: 2280: 2275: 2268: 2266: 2264: 2262: 2258: 2245: 2241: 2240: 2235: 2228: 2225: 2213: 2209: 2202: 2200: 2196: 2184: 2183: 2178: 2171: 2169: 2167: 2165: 2161: 2148: 2144: 2138: 2136: 2134: 2132: 2128: 2123: 2119: 2118: 2113: 2106: 2103: 2098: 2094: 2087: 2084: 2079: 2078: 2073: 2066: 2063: 2058: 2054: 2047: 2045: 2041: 2036: 2032: 2025: 2022: 2017: 2016: 2011: 2004: 2001: 1996: 1992: 1988: 1981: 1979: 1975: 1967:September 10, 1963: 1959: 1952: 1949: 1937: 1933: 1926: 1923: 1911: 1907: 1900: 1897: 1885: 1884: 1879: 1872: 1870: 1866: 1853: 1849: 1845: 1838: 1835: 1823: 1819: 1812: 1810: 1808: 1806: 1802: 1790: 1786: 1779: 1777: 1773: 1761: 1760: 1755: 1748: 1745: 1733: 1729: 1722: 1719: 1707: 1703: 1696: 1693: 1681: 1677: 1670: 1667: 1662: 1658: 1654: 1647: 1644: 1639: 1635: 1628: 1625: 1620: 1616: 1612: 1605: 1602: 1590: 1589: 1584: 1577: 1574: 1569: 1568: 1563: 1556: 1553: 1548: 1547: 1543: 1538: 1531: 1528: 1523: 1522: 1517: 1510: 1507: 1502: 1501: 1496: 1489: 1486: 1481: 1480: 1475: 1468: 1465: 1460: 1459: 1454: 1447: 1444: 1439: 1438: 1433: 1426: 1423: 1418: 1414: 1410: 1403: 1400: 1395: 1394: 1389: 1382: 1379: 1374: 1373: 1368: 1361: 1359: 1355: 1351: 1346: 1343: 1338: 1334: 1333: 1332:The Intercept 1328: 1321: 1319: 1315: 1303: 1299: 1293: 1290: 1285: 1284: 1279: 1272: 1269: 1264: 1263: 1258: 1251: 1248: 1243: 1239: 1234: 1229: 1225: 1221: 1217: 1213: 1209: 1205: 1204: 1199: 1192: 1189: 1184: 1183: 1178: 1171: 1168: 1163: 1159: 1152: 1149: 1144: 1143: 1142:Bloomberg Law 1138: 1131: 1128: 1116: 1115: 1110: 1103: 1101: 1097: 1092: 1088: 1084: 1077: 1074: 1069: 1065: 1058: 1055: 1050: 1046: 1039: 1036: 1031: 1030: 1025: 1018: 1015: 1010: 1006: 1002: 998: 994: 990: 986: 982: 978: 974: 973: 968: 966: 962: 953: 951: 947: 943: 938: 935: 930: 926: 925: 921: 914: 911: 904: 896: 890: 887: 883: 879: 873: 870: 866: 864: 858: 855: 851: 849: 843: 840: 836: 830: 827: 820: 818: 816: 812: 804: 802: 800: 799: 793: 791: 785: 783: 775: 773: 767:Supreme Court 766: 764: 761: 756: 753: 750: 743:Related cases 742: 740: 738: 732: 729: 725: 719: 717: 713: 712: 707: 706: 701: 698: 694: 690: 685: 683: 679: 674: 672: 668: 664: 663:Chuck Schumer 660: 656: 652: 648: 644: 636: 634: 632: 628: 624: 620: 612: 610: 607: 606:oral argument 603: 602:shadow docket 599: 595: 591: 585: 582: 574: 572: 570: 569:Andrew Oldham 566: 562: 557: 555: 547: 545: 542: 537: 533: 528: 526: 522: 518: 514: 510: 505: 501: 496: 494: 490: 482: 477: 475: 474:in the case. 473: 469: 465: 462: 461:HHS Secretary 458: 454: 450: 446: 442: 441:Robert Califf 438: 430: 428: 426: 422: 418: 413: 411: 407: 403: 394: 389: 387: 385: 384: 379: 378: 373: 368: 366: 360: 358: 354: 350: 344: 342: 338: 334: 330: 322: 320: 318: 314: 310: 305: 303: 302:another order 299: 298:Fifth Circuit 295: 290: 288: 287: 282: 281: 276: 272: 268: 264: 260: 259: 249: 245: 242: 238: 234: 231:Case opinions 229: 224: 220: 216: 212: 208: 204: 200: 196: 192: 188: 184: 180: 177: 174: 172: 169: 167:Chief Justice 166: 165: 163: 158: 153: 148: 142: 139: 136: 135: 133: 128: 124: 120: 117: 113: 108: 105: 104:Oral argument 102: 98: 94: 93: 88: 84: 80: 77: 73: 70: 66: 63: 61: 57: 53: 46: 42: 32: 25: 19: 2756: 2722: 2718: 2681: 2675: 2664: 2648: 2642: 2635:SSRN 4335735 2609:. 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Index

Supreme Court of the United States
Food and Drug Administration
23-235
23-236
U.S.
more
Oral argument
210
John Roberts
Clarence Thomas
Samuel Alito
Sonia Sotomayor
Elena Kagan
Neil Gorsuch
Brett Kavanaugh
Amy Coney Barrett
Ketanji Brown Jackson
Food and Drug Administration
mifepristone
medical abortion
Federal Food, Drug, and Cosmetic Act
Dobbs v. Jackson Women's Health Organization
Roe v. Wade
Matthew J. Kacsmaryk
Fifth Circuit
another order
Supreme Court of the United States
standing
Article III
mifepristone

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