WEDNESDAY, April 19, 2023 (HealthDay News) â€“ In the latest move to restrict access to the abortion pill mifepristone in the United States, a coalition of anti-abortion groups on Tuesday asked the Supreme Court to allow an appeals court ruling to stand.
That ruling, issued by the Fifth Circuit Court of Appeals last week, would ratchet back recent changes the U.S. Food and Drug Administration made to ease access to the drug. The ruling would effectively prevent distribution of mifepristone by mail and require more doctor visits to get the medication.
Over decades, the FDA has "stripped away every meaningful and necessary safeguard on chemical abortion, demonstrating callous disregard for womenâ€™s well-being, unborn life, and statutory limits,â€ the court filing from the groups led by the Alliance for Hippocratic Medicine stated.
â€œThe lower courtsâ€™ meticulous decisions do not second-guess the agencyâ€™s scientific determinations; they merely require the agency to follow the law,â€ lawyers for the group added.
Meanwhile, the U.S. Department of Justice and drugmaker Danco Laboratories have already asked the Supreme Court to block the appeals court ruling.
The high court put the ruling on hold last Friday, but it must take its next steps by midnight Wednesday.
The FDA has suggested regulatory chaos could result if the appeals court ruling stands.
The appeals court decision followed an April 7 ruling by Texas-based U.S. District Judge Matthew Kacsmaryk that invalidated the FDA approval in 2000 of mifepristone. In its decision, the appeals court decided that the plaintiffs had waited too long to raise that objection.
Kacsmarykâ€™s ruling would have made it unlawful to distribute mifepristone, the first of two drugs used in a medication abortion.
The appeals court ruling does allow other restrictions Kacsmaryk issued, including suspending a 2021 FDA decision allowing mifepristone to be dispersed via mail. It would also suspend a 2016 change that allowed a patient to have just one in-person medical visit, rather than three. Also suspended would be allowing the pills to be distributed to women who are 10 weeks pregnant, rather than stopping at seven weeks, NBC News reported.
Trade group PhRMA said in a brief filed with the Supreme Court that if the logic of Kacsmarykâ€™s ruling were applied to other drugs, it would upend the â€œsettled regulatory framework and the investments that hinge upon it."
Never before in history could it be said that â€œany court had nullified an FDA approval by second-guessing a safety-and-effectiveness determination,â€ the brief said, according to NBC News.
Among the many abortion-related rulings in recent weeks was another ruling on April 7 in which a federal judge in Washington state prohibited the FDA from â€œaltering the status quo and rights as it relates to the availability of mifepristone.â€ That ruling applies only to 17 states and Washington, D.C.
Without mifepristone, pregnant women could still use the other half of a two-part regimen for medication abortion. However, that drug, misoprostol, may not be as effective when used alone.
Most abortions in the U.S. are done with medication, according to the Guttmacher Institute.
The Association of American Medical Colleges has more on medication abortion.
SOURCE: NBC News
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