The Supreme Court of the United States (SCOTUS) is set to hear oral arguments Tuesday on a challenge to how the federal government oversees the administration of chemical abortion pills.
The drug in question, mifepristone, was initially approved by the Food and Drug Administration (FDA) in 2000 and is one drug in a two-pill regimen, alongside misoprostol, for chemically induced abortions. Danco Laboratories manufactures Mifeprex, the generic name for mifepristone.
Previously, a three-judge panel for the U.S. 5th Circuit Court of Appeals overturned part of a lower court ruling putting increased restrictions on access to the abortion drug.
SCOTUS oral arguments set for Tuesday are preceded by an order that was issued following the 5th Circuit ruling. In an unsigned order from SCOTUS, a stay was issued to allow mifepristone to remain available on the market while the court considers the case.
The stay order stated, “As narrowed by the Court of Appeals, the stay that would apply if we failed to broaden it would not remove mifepristone from the market. It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations.”
While the 5th Circuit panel upheld the FDA approval of mifepristone, it did rule on other challenges pertaining to the lawsuit, initially filed by the Alliance for Defending Freedom (ADF).
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time,” the appeals court ruling stated.
The 5th Circuit decision restricted mifepristone prescriptions to a seven-week window after conception — down from the prior timeframe of 10 weeks — and also required an in-person visit with a physician for a prescription. Additionally, the ruling reinstituted a requirement to report any non-fatal adverse event.
Before SCOTUS there are three questions: whether respondents have Article III standing under the Constitution to challenge the FDA’s 2016 and 2021 actions, whether those FDA actions were arbitrary and capricious, and whether the district court properly granted preliminary relief.
The ADF filed the initial lawsuit against the FDA on behalf of the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, and doctors Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado.
Federal Judge Matthew Kacsmaryk published a stay order against the FDA’s approval of mifepristone in April last year. Another judge in Washington State issued a contradictory ruling to Kacsmaryk’s decision, which left the abortion drug’s approval in limbo, thus forcing SCOTUS action on the issue.
The SCOTUS stay also came after public statements from President Joe Biden that he and his administration are “going to fight” Kacsmaryk’s ruling.
The ADF is now asking SCOTUS to affirm the 5th Circuit Court of Appeals’ decision.
“Women should have the ongoing care of a doctor when taking high-risk drugs. The FDA betrayed women and girls when it unlawfully removed the necessary in-person doctor visits that protected women’s health and well-being,” ADF Senior Counsel Erin Hawley said.
The National Women’s Law Center argues that restricting access to mifepristone would “result in harmful and far-reaching consequences for both patients and providers.”
According to the Guttmacher Institute, which describes itself as “a leading research and policy organization committed to advancing sexual and reproductive health and rights … worldwide,” 63 percent of all abortions in 2023 utilized chemical abortion drugs.
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