Federal judge blocks expanded access to abortion pill mifepristone
A federal judge in Texas has issued a ruling limiting the FDA's approval of mifepristone, the primary drug used in medication abortions. The decision revives a long-standing lawsuit challenging the drug's safety and regulatory process. This comes amid ongoing legal battles over abortion access following the Supreme Court's overturning of Roe v. Wade.
On September 11, 2024, U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, revived a lawsuit filed by the Alliance Defending Freedom on behalf of anti-abortion groups, including the Alliance for Hippocratic Medicine. The suit, originally filed in 2022, argues that the Food and Drug Administration (FDA) improperly relaxed restrictions on mifepristone when it approved expanded access in 2016 and 2021, allowing the drug to be prescribed via telemedicine and mailed without an in-person doctor's visit.
The judge's order halts the FDA's changes, effectively reverting mifepristone's availability to pre-2016 standards in states where abortion is legal. Mifepristone, approved by the FDA in 2000 for terminating pregnancies up to 10 weeks gestation, is used in combination with misoprostol in about two-thirds of U.S. abortions. The ruling does not ban the drug outright but restricts its distribution, potentially affecting access for millions of women.
Kacsmaryk wrote in his 258-page opinion: 'The FDA knowingly disregarded the risk of harm to women and girls from chemical abortion drugs.' He criticized the agency for allegedly ignoring reports of adverse events, including emergency room visits and complications like hemorrhage.
The lawsuit stems from concerns raised by plaintiffs, who claim the FDA failed to adequately assess risks to women and girls, particularly regarding off-label uses and the drug's safety profile. Background context includes the Supreme Court's 2022 Dobbs v. Jackson Women's Health Organization decision, which ended federal protections for abortion and shifted regulation to states. Since then, 14 states have banned most abortions, while others have protected access, leading to a patchwork of laws.
The FDA and drug manufacturer GenBioPro have defended the approvals, citing extensive safety data. In a statement, the FDA noted that mifepristone has been safely used by millions, with serious adverse events occurring in less than 0.4% of cases. The ruling's implications are significant: it could disrupt telemedicine abortions, which surged post-Dobbs, and force clinics to revert to in-person requirements, potentially increasing barriers in rural areas.
Legal experts anticipate appeals, with the case likely heading to higher courts. The Department of Justice, representing the FDA, called the decision 'unprecedented' and vowed to challenge it swiftly. Anti-abortion advocates hailed the ruling as a victory for women's health, while reproductive rights groups warned it endangers access to a safe, common medical procedure.
This development underscores the continued judicial scrutiny of abortion medications, with potential nationwide effects pending further litigation.