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FDA and the abortion pill

Anti-abortion activists protest against the availability of abortion pills at neighborhood pharmacies outside of a CVS Pharmacy on January 18, 2023, in Washington, D.C. Earlier in February, the Food and Drug Administration (FDA) made a regulatory change that now allows retail pharmacies to offer abortion pills to people who have a prescription.
Anti-abortion activists protest against the availability of abortion pills at neighborhood pharmacies outside of a CVS Pharmacy on January 18, 2023, in Washington, D.C. Earlier in February, the Food and Drug Administration (FDA) made a regulatory change that now allows retail pharmacies to offer abortion pills to people who have a prescription. | Drew Angerer/Getty Images

Last month, the Supreme Court agreed to hear the combined cases of FDA et al v. Alliance Hippocratic Medicine et al and Danco Laboratories LLC v. Alliance Hippocratic Medicine et al.

At issue in the litigation is whether the U.S. Food & Drug Administration can lawfully loosen restrictions on how the chemical abortion pill mifepristone can be distributed and who can give it to patients.

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In November 2022, the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians & Gynecologists, the Christian Medical & Dental Associations and four individual doctors sued, seeking to overturn the FDA's 2000 approval of mifepristone and the Biden administration's recent lifting of restrictions.

The administration's policy allows the drug to be distributed by mail or sold at retail pharmacies without requiring women to see a certified doctor or clinician first.

U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas, a Trump appointee, issued a stay in April of the FDA's approval of mifepristone, arguing that "FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions."

Days after the stay was granted, a three-judge panel on the U.S. 5th Circuit Court of Appeals partially granted a request from the Biden administration to stop the decision from taking effect.

The appellate court panel overruled the district court's suspension of the FDA's approval of mifepristone, citing a six-year statute of limitations as justification. However, the appellate court upheld the striking down of the administration's relaxed requirements.

On April 21 of last year, the Supreme Court released an unsigned ruling that allowed the chemical abortion drug to remain on the market while the legal proceedings continued.

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