In a landmark decision, the U.S. Supreme Court has announced its intention to review a legal challenge to the FDA’s approval of mifepristone, a key component in medication abortions. This move marks the first time the conservative-majority Court will address abortion since the controversial overturning of Roe v. Wade, signaling potential shifts in abortion access nationwide and the FDA’s regulatory authority.
Despite being approved over two decades ago, mifepristone’s fate is uncertain as the Supreme Court prepares to weigh in on its legality. During the course of the legal proceedings, the pill will remain available in states where abortion is legal. This development follows the trend of medication abortions accounting for 54 percent of all abortions in the U.S., offering a discreet and accessible option, particularly in the 16 states with restrictive abortion laws.
The legal challenge, a consolidation of FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine, was initiated by the conservative Christian group Alliance Defending Freedom. Their lawsuit, filed in federal court in Texas, aims to reverse the FDA’s approval of mifepristone, dating back to 2000.
Despite the statute of limitations for such challenges being six years, the Alliance argues that the FDA overstepped its regulatory authority and neglected scientific evidence during the approval process. Contrary to their claims, a 2008 report by the Government Accountability Office affirmed the FDA’s proper use of authority in approving and overseeing mifepristone.
Nicole Huberfeld, a public-health-law expert, emphasized that the evidence supporting the safety of medication abortion has only grown over time. Mifepristone, combined with misoprostol in the two-pill regimen, boasts effectiveness rates between 95 and 99 percent, with minimal complications. Huberfeld underscored the FDA’s duty to assess a drug’s safety based on scientific evidence rather than moral perspectives.
The lawsuit also challenges the legality of mailing abortion pills under a federal criminal statute dating back to 1873. Despite disagreement on this interpretation by the Department of Justice, U.S. District Judge Matthew Kacsmaryk, an anti-abortion Trump appointee, ruled in favor of the plaintiffs in April. His decision, laden with anti-choice terminology, questioned the safety record of mifepristone and endorsed the claim that mailing abortion pills violates federal law.
Following Kacsmaryk’s ruling, the Biden administration and Danco Laboratories, the manufacturer of mifepristone, appealed to the Supreme Court. They argued that the lower court’s decision would severely restrict access to the drug nationwide. The Supreme Court, in response, placed the lower court’s order on hold while fully considering the case.
Legal experts suggest that the FDA could choose not to enforce the Texas decision, potentially allowing continued marketing and dispensing of mifepristone. However, the Biden administration rejects this approach, stating it would set a dangerous precedent and plans to challenge the ruling in court.
The Supreme Court’s decision to hear the case has drawn attention to the potential consequences for abortion rights and access. Nancy Northup, president and CEO of the Center for Reproductive Rights, highlighted the significance of this case and urged the Court to reject radical arguments challenging the FDA’s long-standing approval.
As the legal battle unfolds, several states where abortion remains legal have taken proactive measures to secure a supply of mifepristone and misoprostol. California, New York, Massachusetts, and Washington are among the states stockpiling these medications, anticipating potential restrictions imposed by a Supreme Court ruling.
The Court has yet to announce a date for oral arguments, but the case’s outcome will likely be decided next summer. The decision could have profound implications for abortion rights and access across the United States, making it a critical issue that will shape the landscape of reproductive health for years to come.
