Court invalidates FDA approval of mail-order abortion pills.
Access to the Abortion Pill Must Be Restricted, U.S. Appeals Court Rules
The New Orleans-based 5th U.S. Circuit Court of Appeals has ruled that access to the abortion pill mifepristone must be restricted. The court ordered a ban on telemedicine prescriptions and shipments of the drug by mail. However, the decision will not immediately take effect.
The court stopped short of completely pulling the drug off the market, as a lower court had previously done.
The Biden administration plans to appeal the ruling to the U.S. Supreme Court. President Joe Biden, a Democrat, supports abortion rights and has previously ordered the expansion of access to mifepristone.
The ruling will only take effect after the Supreme Court reviews it, which could happen in the upcoming term from October to June.
Background of the Ruling
The ruling stems from a lawsuit brought by four anti-abortion groups and four anti-abortion doctors. They argue that the FDA improperly approved mifepristone in 2000 and did not adequately consider its safety when used by minors.
The 5th Circuit panel reviewed an order by U.S. District Court Judge Matthew Kacsmaryk in Amarillo, Texas. While it was a preliminary ruling, Kacsmaryk indicated that he was likely to make it permanent.
Reactions to the Ruling
Erin Hawley of Alliance Defending Freedom, a lawyer for the anti-abortion groups challenging the pill’s approval, stated, “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.”
Susan B. Anthony Pro-Life America also criticized the FDA, stating that it had been “reckless.”
Alexis McGill Johnson, president of abortion rights group Planned Parenthood Federation of America, expressed concern over the decision, saying that it puts mifepristone’s approval and the FDA’s independence at risk.
GenBioPro Inc, a company that sells a generic version of mifepristone, voiced its concerns about attempts to undermine science and access to evidence-based medication through court challenges.
Conservative Judges and FDA Actions
All three judges on the panel are staunchly conservative and have a history of opposing abortion rights. While one judge wanted to pull mifepristone off the market, the other two judges stated that the lawsuit was filed too late to challenge the drug’s original approval.
The majority of the panel rolled back FDA actions that had made the drug more accessible in recent years. These actions included allowing telemedicine prescriptions and mail shipments, as well as extending the usage period to 10 weeks of pregnancy.
Circuit Judge Jennifer Walker Elrod, in the majority opinion, stated that these changes were made without sufficient consideration of their effects on patients.
Impact and Opposition
Since the U.S. Supreme Court overturned the Roe v. Wade ruling, at least 15 states have outright banned abortion, and many others have imposed restrictions based on the length of pregnancy.
Mifepristone is a crucial part of medication abortions, which account for over half of all abortions in the U.S. Numerous studies and real-world use have shown that the drug is safe and effective.
Major medical associations, including the American College of Obstetricians and Gynecologists and the American Medical Association, have warned that pulling mifepristone off the market would harm patients by forcing them to undergo more invasive surgical abortions.
(Reporting By Brendan Pierson in New York; Additional reporting by Patrick Wingrove in New York, Nate Raymond in Boston, Sharon Bernstein in Sacramento, California and Trevor Hunnicutt in Washington; Editing by Cynthia Osterman)
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