Federal Appeals Court Hears Arguments on Future of Mifepristone
On Wednesday, a federal appeals court in the US heard arguments about the future of mifepristone, a drug commonly used in a two-pill regimen for abortion and miscarriage care. The three-judge panel at the Ninth Circuit Court of Appeals was tasked with reviewing the legal challenge to the Food and Drug Administration’s (FDA) 2000 approval of mifepristone. Last month, the US Supreme Court upheld a stay that kept the drug on the market and punted the decision about its future back to the appeals court. While the judges questioned the drug’s safety, they also interrogated plaintiffs’ claim that doctors who object to abortion were being forced to provide care under current mifepristone regulations.
Much of the hearing focused on whether a group of anti-abortion doctors has legal standing to challenge the FDA’s approval of mifepristone. According to medical professionals and organizations, the approval of mifepristone by the FDA and subsequent actions taken since 2016 have placed them in circumstances that require them to carry out elective abortions, which goes against their right to conscience. More than two decades ago, the FDA granted approval for mifepristone to be used in abortions and miscarriages within the first seven weeks of pregnancy. In 2016, this approval was expanded to cover up to 10 weeks of pregnancy, which is the period when most abortions take place. Later on, the FDA relaxed the requirements for in-person prescription. In a span of more than 20 years, serious side effects have been reported by less than 1% of those who have used mifepristone.
The case has significant stakes that stretch far beyond abortion: if a court can choose to upend the FDA’s approval process for one drug, experts say, every other drug’s approval could be at risk. After a Texas judge’s ruling, more than 300 past and current pharmaceutical industry executives signed a letter condemning it. In the event that mifepristone is no longer available or its accessibility is limited, numerous abortion clinics have indicated their intention to switch to inducing medication abortions through the use of only misoprostol, the alternative drug frequently utilized in medication abortions. A court ruling would also not impact the thriving underground market for abortion pills, since that market operates outside of the US legal system.
The case was presided over by a panel of three judges, comprising of two appointees of Trump, namely Judges James Ho and Cory Wilson, and one appointee of Bush, namely Judge Jennifer Walker Elrod. The three individuals possess a history of being against abortion. Elrod has expressed her opinion on numerous cases, including her endorsement of verdicts that uphold the necessity for doctors at abortion clinics in Louisiana and Texas to possess hospital admitting privileges. Jennifer Walker Elrod, a nominee selected by George W. Bush, has consistently upheld state laws related to abortion. Both Ho and Wilson come from conservative political backgrounds. In a 2018 opinion, Ho referred to abortion as a “moral tragedy”. Having been a critic of Roe v. Wade for a long time, Wilson, during his time in the Mississippi state legislature, cast his vote in favor of prohibiting abortion after 6 weeks of pregnancy and withdrawing funding from Planned Parenthood.
Should the initial judge's decision be affirmed, the availability of medication abortion would be disrupted in all states where abortion is lawful, not just those with prohibitions and limitations in effect. Pharmaceutical companies have expressed concern that uncertainty surrounding the FDA's regulatory authority over drugs could hamper drug development in the United States, and there is potential for further legal challenges to arise. All three judges questioned the regulatory basis for the drug’s approval and expanded access, while steering clear of a national debate over abortion itself, following the US Supreme Court’s ruling last June removing a constitutional right to the procedure. Legal analysts predict that the matter will ultimately return to the supreme court.
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