WASHINGTON – The Supreme Court On Tuesday, the Food and Drug Administration considered whether to allow the abortion pill mifepristone to become widely available because of its high stakes in the drug approval process.
The court, which has a 6-3 conservative majority, is hearing oral arguments on the Biden administration’s appeal of lower court rulings restricting access to the pill, including by mail order.
Mifepristone is used as part of a two-drug FDA-approved treatment regimen most abortions nationwide.
The case is a landmark decision in 2022, Roe v. Overturning Wade is a major test for the conservative majority court.
A group of anti-abortion doctors represented by the Alliance Defending Freedom, a conservative Christian rights group, is leading the legal challenge, arguing that the FDA failed to adequately assess the drug’s safety risks.
The FDA has the support of the pharmaceutical industry, which has warned that any second-guessing of the approval process by untrained federal judges could be a challenge. it causes chaos and prevents innovation.
Danco, which makes a brand-name version of the pill called Mifeprex, is arguing alongside the FDA in the oral argument.
The oral argument comes nearly a year after Texas-based U.S. District Judge Matthew Kaczmaric issued a sweeping ruling invalidating the FDA’s approval of the pill, prompting panic among abortion rights activists that it would be banned outright.
Last April, the Supreme Court stayed that decision, meaning the pill is still widely available.
In August, the 5th U.S. Circuit Court of Appeals in New Orleans later narrowed Kacsmaryk’s appeal but upheld the FDA’s decision to lift the restrictions beginning in 2016.
Both parties appealed to the Supreme Court. In December, the court accepted an appeal by the Biden administration to defend subsequent FDA decisions, but it declined to hear a challenge to the original approval of mifepristone in 2000. Therefore, this issue is not before justice.
The court will instead focus on the FDA’s subsequent action, including the preliminary ruling that mailed it in 2021 and was finalized last year.
The court will also consider decisions in 2016 to extend the window in which mifepristone can be used to terminate a pregnancy from seven weeks to 10 weeks and to reduce the number of personal visits for patients from three to one. In another move in 2016, the FDA changed the dosing regimen, finding that a lower dose of mifepristone was sufficient.
One way the court could throw out the case would be to find that the plaintiffs lack legal standing to bring their claims, which means the judges won’t be wrestling with the issue of FDA approval. If the court takes this path, it will leave the door open for future cases.
In court filings, the FDA argued that the doctors and others suing lacked standing because they failed to show any traceable harm during the drug’s approval process.
Doctors do not prescribe mifepristone, but they claim they are injured because they may be required to treat patients who take the pill and have serious side effects. Because the plaintiffs were against abortion, any action they were forced to take to complete the process would make them complicit, the plaintiffs argued. court documents.
If access to the drug is restricted, the outcome of the case could have far-reaching practical implications, with many states following the Supreme Court’s decision in Roe v. Wade seeks to limit access to abortion after decision to overturn case.
According to the Guttmacher Institute, a research group that supports abortion rights, there are 14 states where abortion is outright banned.