NEW ORLEANS (AP) — New restrictions on access to a drug used in the most common form of abortion in the U.S. would be imposed under a federal appeals court ruling issued Wednesday, but the Supreme Court will have the final say.
The decision by three judges on the 5th U.S. Circuit Court of Appeals in New Orleans overturned part of a lower court ruling that would have revoked the Food and Drug Administration’s 23-year-old approval of mifepristone. But it left intact part of the ruling that would end the availability of the drug by mail, allow it to be used through only the seventh week of pregnancy rather than the 10th, and require that it be administered in the presence of a physician.
The FDA granted access to mifepristone in 2000. The panel's ruling would reverse changes the FDA made in 2016 and 2021 to loosen some conditions for administering the drug. The FDA declined to comment on the ruling. There is virtually no precedent for a U.S. court overturning the approval of a drug that the FDA has deemed safe and effective. While new drug safety issues often emerge after FDA approval, the agency is required to monitor medicines on the market, evaluate emerging issues and take action to protect U.S. patients. Congress delegated that responsibility to the FDA — not the courts— more than a century ago.
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