USALife.info / NEWS / 2023 / 08 / 16 / APPEALS COURT UPHOLDS FDA'S 2000 ABORTION PILL APPROVAL, CRITICIZES RELAXED RESTRICTIONS
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Appeals court upholds FDA's 2000 abortion pill approval, criticizes relaxed restrictions

18:20 16.08.2023

In a major development in the ongoing legal battle over the abortion pill mifepristone, a United States appeals court has issued a ruling that imposes restrictions on the drug but does not revoke its approval by the Food and Drug Administration (FDA). The three-judge panel of the Fifth Circuit Court of Appeals in New Orleans overturned a lower court's decision that had revoked the FDA's approval of mifepristone. However, the court upheld part of the lower court's ruling, which limited the drug's availability by mail and restricted its use to up to seven weeks of pregnancy instead of ten. The court also required that mifepristone be prescribed by a doctor after an in-person visit, reversing the FDA's decision in 2016 to loosen guidelines for the drug.

The decision comes after a Texas judge in April revoked the FDA's approval of mifepristone, putting one of the most common methods of abortion in the US at risk. The latest ruling will likely be appealed to the conservative-dominated US Supreme Court, as the Biden administration has vowed to protect access to mifepristone and defend the FDA's authority.

The appeals court ruling prevents mifepristone from being prescribed via telemedicine or shipped by mail, but it does not order the drug off the market entirely. The court determined that the FDA's previous regulations for mifepristone were unlawful and rolled back recent changes that had made the drug more accessible. These changes included allowing distribution by mail, extending the time frame for use, reducing the dosage, and reducing the number of required in-person visits.

The ruling has sparked controversy and debate among various parties. Anti-abortion groups and doctors who oppose the drug's approval argue that the FDA did not adequately consider its safety, especially for use by minors. They also claim that the drug's accessibility has increased the number of medication abortions, which now account for over half of all pregnancy terminations in the US. On the other hand, medical associations and experts argue that mifepristone is safe and effective, and pulling it off the market would harm patients by forcing them to undergo more invasive surgical abortions.

The decision will likely be appealed to the full Fifth Circuit and eventually to the US Supreme Court, which recently overturned the landmark Roe v. Wade ruling that legalized abortion nationwide. The outcome of the case will have significant implications for access to mifepristone and the future of abortion rights in the US.

/ Wednesday, August 16, 2023, 6:20 PM /

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