Supreme Court Unanimously Rules in Against Challenge to Mifepristone

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The Supreme Court issued a unanimous ruling against a lawsuit that challenged FDA’s clearance of Mifepristone.¹ A court in Texas had previously issued a ruling that would have undone FDA’s approval of the pill in 2000 and the agency’s lifting of restrictions in 2016. While an appeals court undid part of the original decision, it maintained the section of the ruling that would have undone the lifting of restrictions.

The case raised concerns among those in the pharmaceutical industry, as many felt it would undermine the authority of FDA to properly regulate drugs.

In the recent ruling, however, the Supreme Court decided that the plaintiffs did not have standing to sue, and the entirety of the original decision has been reversed.

Mifepristone distributor Danco Laboratories issued a press release acknowledging the decision.² In it, Abby Long, vice president of marketing and public affairs, said, “We are pleased with the Supreme Court's decision in this incredibly important case. By rejecting the Fifth Circuit's radical, unprecedented and unsupportable interpretation of who has standing to sue, the justices reaffirmed longstanding basic principles of administrative law. In doing so, they maintained the stability of the FDA drug approval process, which is based on the agency's expertise and on which patients, healthcare providers and the US pharmaceutical industry rely.”

Long continued, “The decision also safeguards access to a drug that has decades of safe and effective use. As the sponsor of Mifeprex® (mifepristone) tablets, the first and only brand-name drug approved for use in medical abortion, Danco is proud to have led the way in obtaining FDA approval of this essential reproductive health option and of modifications to the conditions under which it can be used. We thank the Court for its careful analysis and remain committed to developing and bringing to market safe and effective products in this crucial area of public health."

Planned Parenthood of Metropolitan Washington D.C. (PPMW) also issued a statement saying that it will continue to offer the medication at health centers in the area.³

In the press release, PPMW president and CEO Dr. Laura Meyers said, “Abortion is a fundamental freedom and medication abortion is essential health care. While we are relieved that we can continue to provide medication abortion that meets the top standard of care, we remain incensed that access to mifepristone was ever at risk."

PPMW chief medical officer Dr. Serina Floyd added, “Access to mifepristone is a health equity issue. Had mifepristone been restricted, the existing health inequities experienced by marginalized and minoritized communities across the nation, including in the DC metro area, would have been dramatically exacerbated. While we are relieved that mifepristone access has not been restricted, we remain vigilant, given the broad range of threats facing abortion care today. The wellbeing of our patients is always our top priority."

Sources

1. Fritze, John; Sneed, Tierney. Supreme Court Rejects Challenge to Abortion Pill Mifepristone, Allowing Drug to Stay on the Market. CNN. June 13, 2024. https://www.cnn.com/2024/06/13/politics/supreme-court-rejects-challenge-abortion-pill-mifepristone/index.html
2. Danco Laboratories LLC Comments on US Supreme Court Decision. June 13, 2024. https://www.prnewswire.com/news-releases/danco-laboratories-llc-comments-on-us-supreme-court-decision-302172232.html
3. Planned Parenthood of Metropolitan Washington, DC, Comments on Maintaining Access to Medication Abortion Following U.S. Supreme Court Decision. Planned Parenthood of Metropolitan Washington, D.C. June 13, 2024. https://www.prnewswire.com/news-releases/planned-parenthood-of-metropolitan-washington-dc-comments-on-maintaining-access-to-medication-abortion-following-us-supreme-court-decision-302172382.html