December 24, 2024

Pedestrians walk in front of the U.S. Supreme Court on February 29, 2024 in Washington, DC.

Robert Nickelsberg | Getty Images

this Supreme Court The discussion Tuesday was about whether to continue widespread use of the abortion drug mifepristone, as it weighed high-stakes challenges to the U.S. Food and Drug Administration’s drug approval process.

The court’s 6-3 conservative majority heard oral arguments in the Biden administration’s appeal of a lower court ruling restricting access to drugs, including by mail.

Mifepristone is used as part of an FDA-approved two-drug regimen most abortions Nationwide.

The case is a major test for the conservative-majority court, which in 2022 overturned Roe v. Wade, the landmark ruling 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, is leading the legal challenge, claiming the FDA failed to adequately assess the drug’s safety risks.

The FDA is backed by the pharmaceutical industry, which warns that any second-guessing of the approval process by untrained federal judges could lead to Creates confusion and hinders innovation.

Danco, which makes Mifeprex, a branded version of the pill, argued with the FDA during oral arguments.

The oral arguments came after U.S. District Judge Matthew Kacsmaryk in Texas issued a sweeping ruling that entirely invalidated the FDA’s approval of the drug, prompting abortion-rights campaigns People are panicking, fearing the drug will be banned altogether.

Last April, the Supreme Court put that ruling on hold, meaning the drug remains widely available for now.

In August, the 5th U.S. Circuit Court of Appeals in New Orleans narrowed Kacsmaryk’s appeal but upheld his ruling that the FDA’s move to lift restrictions starting in 2016 was unlawful.

Both sides appealed to the Supreme Court. The court in December accepted the Biden administration’s appeal defending the FDA’s later decision, but it chose not to hear a challenge to mifepristone’s original approval in 2000. Therefore, the issue was not brought before the judge.

Instead, the court will focus on the FDA’s subsequent actions, including the 2021 preliminary decision that was finalized last year and provided by mail.

The court will also consider a decision in 2016 to extend the window for mifepristone to terminate a pregnancy from 7 weeks to 10 weeks, and to reduce 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 a lower dose of mifepristone was sufficient.

One way the court would approach the case would be to conclude that the challengers had no legal standing to sue, meaning the judge wouldn’t dwell on the issue of FDA approval. If the court takes this approach, it opens the door to future cases.

The FDA argued in court papers that the doctors and others who filed the lawsuit had no legal standing because they could not prove any harm that could be traced back to the drug approval process.

Doctors did not prescribe mifepristone, but they argued they were injured because they might need to treat patients who were taking the drug and experiencing serious side effects. The plaintiffs argue in the book that because they oppose abortion, any action they are forced to take to help women through the abortion process makes them complicit. court documents.

The outcome of the case could have wide-ranging practical implications if it restricts access to the drug, with many states seeking to restrict abortion in the wake of the Supreme Court’s decision to overturn Roe v. Wade.

According to the Guttmacher Institute, a research group that supports abortion rights, 14 states have virtually outright abortion bans.

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