Food and Drug Administration v. Alliance for Hippocratic Medicine
 | |
| Food and Drug Administration v. Alliance for Hippocratic Medicine | |
| Term: 2023 | |
| Important Dates | |
| Argued: March 26, 2024 Decided: June 13, 2024 | |
| Outcome | |
| reversed and remanded | |
| Vote | |
| 9-0 | |
| Majority | |
| Brett Kavanaugh • Chief Justice John Roberts • Samuel Alito • Sonia Sotomayor • Elena Kagan • Neil Gorsuch • Amy Coney Barrett • Ketanji Brown Jackson | |
| Concurring | |
| Clarence Thomas | |
Food and Drug Administration v. Alliance for Hippocratic Medicine is a U.S. Supreme Court case decided unanimously on June 13, 2024, concerning the Food and Drug Administration’s 2016 and 2021 actions related to the approved conditions of use of mifepristone—a drug used in medication abortions. The U.S. Supreme Court held that the plaintiffs did not have standing to challenge the agency's regulatory actions.
The case was argued before the Supreme Court of the United States on March 26, 2024, during the court's October 2023-2024 term. It was consolidated with Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine.[1]
"1. Whether respondents have Article III standing to challenge FDA's 2016 and 2021 actions. 2. Whether FDA's 2016 and 2021 actions were arbitrary and capricious. 3. Whether the district court properly granted preliminary relief."[2]
"1. Whether an association can demonstrate Article III standing to enjoin a government action by arguing that some unspecified member may be injured at some future time by the challenged action; and 2. Whether the Fifth Circuit erred in upholding the preliminary injunction of FDA's 2016 and 2021 actions based on the court's review of an incomplete administrative record."[3]
The cases came on a writ of certiorari to the United States Court of Appeals for the Fifth Circuit. To review the lower court's opinion, click here.[4]
Why it matters: The court’s decision in the case clarified that the group of doctors and medical groups that filed the lawsuit lacked standing to challenge the agency’s regulatory actions because they did not demonstrate that they would be harmed by the FDA’s regulations.
Timeline
The following timeline details key events in these cases:
- June 13, 2024: The U.S. Supreme Court reversed and remanded the decision of the United States Court of Appeals for the Fifth Circuit.
- March 26, 2024: The U.S. Supreme Court heard oral argument.
- December 13, 2023: The U.S. Supreme Court agreed to hear the cases.
- September 8, 2023: Food and Drug Administration and Danco Laboratories, L.L.C. appealed to the U.S. Supreme Court.
- August 16, 2023: The United States Court of Appeals for the Fifth Circuit vacated in part and affirmed in part the opinion of the United States District Court for the Northern District of Texas.[5]
Background
| Administrative State |
|---|
| Five Pillars of the Administrative State |
| • Judicial deference • Nondelegation • Executive control • Procedural rights • Agency dynamics |
| Click here for more coverage of the administrative state on Ballotpedia |
The Food and Drug Administration (FDA) approved the drug mifepristone in 2000 to be used in medication abortions. The FDA in 2016 and 2021 changed certain conditions regarding the use of the drug to allow it to be used through the tenth week of pregnancy, to authorize certain healthcare providers to prescribe it, and to allow it to be prescribed through telehealth appointments.[6]
A group of doctors and medical groups challenged the agency’s approval of mifepristone in 2022, arguing that the drug was unsafe. The United States Court of Appeals for the Fifth Circuit ruled that the group could not challenge the 2000 approval of mifepristone, however, the court ruled that “the FDA’s 2016 and 2021 actions increasing access to the drug, such as allowing it to be used later in pregnancy and allowing it to be prescribed through telehealth appointments, should be put on hold.”[7]
The Biden administration and Danco Laboratories, L.L.C. appealed the decision to the Supreme Court, arguing that the agency’s action was based on scientific judgment about the drug’s safety. U.S. Solicitor General Elizabeth Prelogar, who is representing the Biden administration, argued that the Fifth Circuit’s ruling was “the first time any court has restricted access to an FDA-restricted drug based on disagreement with FDA’s expert judgment about the conditions required to assure that drug’s safe use—much less done so after those conditions had been in effect for years,” according to SCOTUSblog.[7]
The United States Supreme Court agreed to hear Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine together in the October 2023-2024 term.
Questions presented
The petitioners presented the following questions to the court:
Questions presented in Food and Drug Administration v. Alliance for Hippocratic Medicine:
|
Questions presented in Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine:
|
Oral argument
Audio
Audio of oral argument:[9]
Transcript
Transcript of oral argument:[10]
Outcome
The court ruled 9-0 that the plaintiffs did not have standing to challenge the FDA’s regulatory actions. It reversed and remanded the United States Court of Appeals for the Fifth Circuit ruling.
Justice Brett Kavanaugh delivered the opinion of the court. Justice Clarence Thomas delivered a concurring opinion.[1]
Opinion
Opinion of the court
Justice Brett Kavanaugh delivered the opinion of the court, which argued that the plaintiffs lack standing to challenge the Food and Drug Administration’s regulatory actions related to mifepristone:[11]
| “ |
The plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone. But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court. Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions. The plaintiffs may present their concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the legislative process. And they may also express their views about abortion and mifepristone to fellow citizens, including in the political and electoral processes.[8] |
” |
Concurring opinion
Justice Clarence Thomas delivered a concurring opinion, joining the majority opinion in full. Thomas argued that the case presents a problem with the associational standing doctrine, which refers to an association’s standing to sue on behalf of their members. He wrote that consideration of the associational standing doctrine was not necessary to decide the case, but “in an appropriate case, however, the Court should address whether associational standing can be squared with Article III’s requirement that courts respect the bounds of their judicial power”:[11]
| “ |
Associational standing seems to run roughshod over this traditional understanding of the judicial power. Our doctrine permits an association to have standing based purely upon a member’s injury, not its own. 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. See Brief for Professor F. Andrew Hessick as Amicus Curiae 28 (explaining that, among other associations, the American Association of Retired People’s “potential standing is staggering” because our doctrine permits it to “sue to redress” the injury of a single member out of its “almost thirty-eight million members”). As I have already explained in the context of third-party standing, Article III does not allow a plaintiff to seek to vindicate someone else’s injuries. See June Medical, 591 U. S., at 364–366 (opinion of Thomas, J.); Kowalski, 543 U. S., at 135 (opinion of Thomas, J.). It is difficult to see why that logic should not apply with equal force to an association as to any other plaintiff. I thus have serious doubts that an association can have standing to vicariously assert a member’s injury.[8] |
” |
Text of the opinion
Read the full opinion here.
Commentary about the case
Pre-decision commentary
Laurie Sobel, Alina Salganicoff, and Mabel Felix—part of the Women’s Health Policy team for the health policy organization KFF—published a policy brief outlining what they viewed as the potential implications of the SCOTUS decision in FDA v. Alliance for Hippocratic Medicine: “While the Supreme Court stated in the Dobbs decision that it ‘returns the issue of abortion to the people’s elected representatives,’ the outcome of this case could limit access to medication abortion throughout the country, including in states where abortion is legal and protected. The interest in this case expands far beyond the issue of access to mifepristone and abortion; many people are watching whether the Court will block the FDA’s independence in determining the conditions required to assure a drug’s safe use— something the Court has never done before.”[12]
Erik Baptist, senior counsel for the nonprofit Alliance Defending Freedom, published commentary for The Federalist Society arguing that the plaintiffs have standing to sue, in his view, based on precedent established by SCOTUS cases such as Summers v. Earth Island Institute and Massachusetts v. Environmental Protection Agency: “[T]he plaintiff doctors explain that restoring the safeguards that the FDA removed will likewise reduce the probability of their injuries. Given its decades-old precedent, the Supreme Court must (1) find that the doctors can sue the FDA, (2) overrule its precedent, or (3) create a double standard. There are no other options.”[13]
Post-decision commentary
Congresswoman Mikie Sherrill (D-N.J.) released a statement supporting the SCOTUS decision but calling for further protections to be implemented by Congress: "Today, women in New Jersey and across the country are breathing a temporary sigh of relief at the Supreme Court’s decision, as Mifepristone remains safe, effective, and legal. But make no mistake – reproductive freedom is under attack and we cannot take comfort in a ruling based on standing alone, leaving the door open for future challenges to abortion rights. That’s why Congress needs to pass the Women’s Health Protection Act, the Right to Contraception Act, and reform the Comstock Act so it cannot be weaponized by extreme Washington Republicans to enact a nationwide abortion ban."[14]
President and CEO of the Center for Reproductive Rights Nancy Northup released a statement in support of the SCOTUS ruling arguing, “I have both relief and anger about this decision. Thank goodness the Supreme Court unanimously rejected this unwarranted attempt to curtail access to medication abortion, but the fact remains that this meritless case should never have gotten this far. … In the end, this ruling is not a ‘win’ for abortion—it just maintains the status quo, which is a dire public health crisis in which 14 states have criminalized abortion.”[15]
Carmel Richardson, a contributing editor for The American Conservative, wrote against the SCOTUS ruling arguing that the decision is what she referred to as a win for the administrative state: “If mifepristone can be questioned, other drugs which FDA has approved despite harmful side effects—of which there are a concerning number—might also be brought to trial. All of which naturally makes one wonder who, if not the courts, might provide any check on the agency that has approved these drugs that many view as harmful. In theory, administrative oversight is the role of Congress, but in practice Congress seems just as impotent.”[16]
Erin Hawley, senior counsel for the nonprofit Alliance Defending Freedom, released a statement against SCOTUS’ decision: “We are disappointed that the Supreme Court did not reach the merits of the FDA’s lawless removal of commonsense safety standards for abortion drugs. … While we’re disappointed with the court’s decision, we will continue to advocate for women and work to restore commonsense safeguards for abortion drugs—like an initial office visit to screen for ectopic pregnancies. And we are grateful that three states stand ready to hold the FDA accountable for jeopardizing the health and safety of women and girls across this country."[17]
October term 2023-2024
The Supreme Court began hearing cases for the term on October 2, 2023. The court's yearly term begins on the first Monday in October and lasts until the first Monday in October the following year. The court generally releases the majority of its decisions in mid-June.[18]
See also
External links
- Search Google News for this topic
- U.S. Supreme Court docket file - Food and Drug Administration v. Alliance for Hippocratic Medicine (petitions, motions, briefs, opinions, and attorneys)
- SCOTUSblog case file for Food and Drug Administration v. Alliance for Hippocratic Medicine
- U.S. Supreme Court docket file - Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine (petitions, motions, briefs, opinions, and attorneys)
- SCOTUSblog case file for Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine
Footnotes
- ↑ 1.0 1.1 SCOTUSblog, "Food and Drug Administration v. Alliance for Hippocratic Medicine," accessed January 3, 2024
- ↑ 2.0 2.1 SCOTUS, "23-235 FOOD AND DRUG ADMINISTRATION V. ALLIANCE FOR HIPPOCRATIC MEDICINE", granted December 13, 2023
- ↑ 3.0 3.1 SCOTUS, "23-236 DANCO LABORATORIES, LLC V. ALLIANCE FOR HIPPOCRATIC MEDICINE," granted December 13, 2023
- ↑ SCOTUSblog, "Food and Drug Administration v. Alliance for Hippocratic Medicine," accessed December 21, 2023
- ↑ Casetext, "All. for Hippocratic Med. v. U.S. Food & Drug Admin.," August 16, 2023
- ↑ SCOTUSblog, "Justices will review lower-court ruling on access to abortion pill," December 13, 2023
- ↑ 7.0 7.1 SCOTUSblog, "Federal government and drug manufacturer ask court to review ruling restricting access to abortion medication," September 10, 2023
- ↑ 8.0 8.1 8.2 8.3 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
- ↑ Supreme Court of the United States, "Oral Argument - Audio," argued March 26, 2024
- ↑ Supreme Court of the United States, "Oral Argument - Transcript," argued March 26, 2024
- ↑ 11.0 11.1 Justia, "FDA v. Alliance for Hippocratic Medicine, 602 U.S. _ (2024)," accessed June 13, 2024
- ↑ KFF, "What's at Stake for Access to Medication Abortion and the FDA in the Supreme Court Case FDA v. the Alliance for Hippocratic Medicine?" March 21, 2024
- ↑ The Federalist Society, "Of Beetles and Babies: The Possible Futures for Standing after FDA v. Alliance for Hippocratic Medicine," June 6, 2024
- ↑ U.S. Congresswoman Mikie Sherrill, "Sherrill Statement on FDA vs. Alliance for Hippocratic Medicine," June 13, 2024
- ↑ Center for Reproductive Rights, "Supreme Court Ruling Maintains Access to Mifepristone," June 13, 2024
- ↑ [https://www.theamericanconservative.com/what-the-abortion-pill-ruling-means-for-conservatives/ The American Conservative, "Why the Abortion Pill Ruling Is About the Administrative State," June 17, 2024]
- ↑ Alliance Defending Freedom, "U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine," June 13, 2024
- ↑ SupremeCourt.gov, "The Supreme Court at Work: The Term and Caseload," accessed January 24, 2022
| ||||||||||||||||||||||||||||
| |||||||||||
| |||||||||||