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Appeals Court Upholds Restrictions on Mifepristone

Medically reviewed by Drugs.com.

By Physician’s Briefing Staff HealthDay Reporter

THURSDAY, Aug. 17, 2023 -- The abortion pill mifepristone should remain legal in the United States, but with significant restrictions on access to it, a federal appeals court ruled Wednesday. The decision, issued by the U.S. Court of Appeals for the Fifth Circuit in New Orleans, effectively sets the stage for a showdown before the Supreme Court on the fate of the drug.

The lower court ruling from Texas that the federal appeals court weighed would have fully revoked the U.S. Food and Drug Administration approval of the medication back in 2000. Instead, this latest decision will end availability of the drug by mail or telemedicine. The three-judge panel also said mifepristone can only be used through seven weeks, instead of 10, and the drug will be required to be administered with a doctor present, the Associated Press reported.

"In loosening mifepristone's safety restrictions, [the] FDA failed to address several important concerns about whether the drug would be safe for the women who use it," wrote Judge Jennifer Walker Elrod, a George W. Bush appointee to the Fifth Circuit.

But the American Medical Association (AMA) took issue with the new ruling. "Today's decision by the Fifth Circuit Court of Appeals continues to signal a move in the wrong direction on access to mifepristone, potentially eliminating the ability to prescribe and dispense mifepristone via telemedicine and reinstating barriers to access that lack scientific evidence," Jack Resneck, M.D., immediate past president of the AMA, said in a statement. "While this decision preserves the original approval of Mifeprex and generic mifepristone, this action will undoubtedly negatively impact patients across the country if left in place."

However, none of the restrictions will happen yet because the Supreme Court intervened in April to allow availability of the drug while the Texas case works its way through the courts. The Supreme Court, which will likely act in the coming months, could deny review, leaving in place the appeals court's ruling, curbing access to the pill. Or it could agree to hear the appeal, throwing the future of the abortion pill in doubt, The New York Times reported.

The original Texas lawsuit was filed by conservative Christian group the Alliance Defending Freedom (ADF). An earlier lawsuit filed by that group led to the Supreme Court's decision to overturn Roe v. Wade after nearly five decades.

Reacting to the news, the alliance issued a statement applauding the ruling. "The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions," said ADF Senior Counsel Erin Hawley, who is also vice president of the ADF Center for Life and Regulatory Practice. "The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen."

Health care providers have said they will switch to using only the other drug used in the typically two-drug medication abortions. That medication, misoprostol, is somewhat less effective, the AP reported.

Associated Press Article

The New York Times Article

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2024 HealthDay. All rights reserved.

Posted August 2023

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