WASHINGTON – The Supreme Court will weigh on Tuesday whether to maintain widely available access to the abortion drug mifepristone as it considers a high-stakes challenge to the Food and Drug Administration's drug approval process.
The court, with a 6-3 conservative majority, will hear oral arguments on the Biden administration's appeal of a lower court ruling that restricted women's access to the pill, including by mail.
Mifepristone is used as part of an FDA-approved two-drug therapy for the vast majority of abortions across the United States.
The case is a major test for the conservative-majority court, which in 2022 overturned Roe v. Wade, the landmark decision that established a woman's constitutional right to terminate a pregnancy.
A group of anti-abortion doctors, represented by the conservative Christian legal group Alliance Defending Freedom, has filed a legal challenge, arguing that the FDA failed to properly evaluate the drug's safety risks. Leading.
The FDA, backed by the pharmaceutical industry, has warned that letting untrained federal judges second-guess the approval process could cause confusion and stifle innovation.
Danko, which makes the branded version of the pill Mifeprex, is arguing alongside the FDA in oral argument.
The oral argument comes after Texas-based U.S. District Judge Matthew Kaksmarik issued a sweeping ruling that completely invalidated the FDA's approval of the pill. It comes almost a year after it sparked panic that it would be banned.
The Supreme Court in April last year put the ruling on hold, meaning the pill remains widely available for now.
The New Orleans-based 5th Circuit Court of Appeals subsequently narrowed down Kaczmarik's appellate ruling in August, but his ruling that the FDA's move to lift restrictions that began in 2016 was illegal. I left it as is.
Both appealed to the Supreme Court. In December, the court took up the Biden administration's appeal defending subsequent FDA decisions, but chose not to hear a challenge to mifepristone's original approval in 2000. Therefore, the matter will not be heard before a judge.
The court will instead focus on subsequent FDA cases, including an initial decision in 2021 that allowed delivery by mail, which was finalized last year.
The court will also consider a 2016 ruling that extended the period during which mifepristone can be used for abortions from seven weeks to 10 weeks of pregnancy and reduced the number of in-person patient visits from three to one. In another move in 2016, the FDA changed the dosing regimen and found that lower doses of mifepristone were sufficient.
One way the court could handle this case would be to conclude that the challenger lacks legal standing to sue. That means the judge won't address FDA approval issues. If the court takes that path, it would leave the door open for future litigation.
In court documents, the FDA argues that the doctors who filed the lawsuit lack legal standing because they cannot prove their injuries were caused by the drug's approval process.
Doctors say they are injured because they do not prescribe mifepristone but may need to treat patients who take the pills and develop serious side effects. Because they oppose abortion, the plaintiffs argued in court documents, any action coerced to help a woman complete an abortion constitutes complicity.
Many states are seeking to restrict access to abortion in the wake of the Supreme Court's decision to overturn Roe v. Wade, and the consequences of this case could have far-reaching practical implications if access to the drug is restricted. may have an impact.
According to the Guttmacher Institute, a research group that supports abortion rights, there are 14 states with de facto total bans on abortion.
