Missouri Attorney General Files Lawsuit Challenging FDA Approval of Generic Abortion Pill

JEFFERSON CITY, Mo. — November 20, 2025 — Missouri’s attorney general has initiated legal proceedings against the U.S. Food and Drug Administration (FDA), contesting the agency’s approval of a generic version of the abortion pill mifepristone. The lawsuit raises concerns about the safety of mail-order abortion medications and their alleged connection to hospital complications, officials said.

The suit, filed in federal court, challenges the FDA’s decision to authorize a generic form of mifepristone, a medication commonly used in medication-induced abortions. Missouri’s attorney general argues that the approval process did not adequately address safety risks, particularly those associated with the distribution of abortion pills through mail-order services.

According to the complaint, the attorney general’s office contends that the generic mifepristone poses health risks that have resulted in increased hospital visits and complications. The filing asserts that the FDA’s approval failed to sufficiently consider these potential dangers, which the state says warrant heightened regulatory scrutiny.

The FDA has maintained that mifepristone, including its generic versions, is safe and effective when used as directed. The agency’s approval process involves rigorous evaluation of clinical data and safety profiles before authorizing any medication for public use. Mifepristone has been approved by the FDA since 2000 and is widely used in combination with misoprostol for medication abortions.

Mail-order distribution of abortion pills has expanded in recent years, particularly in response to changes in abortion access and regulations across various states. Proponents argue that mail delivery increases access to reproductive healthcare, especially in areas with limited clinical providers. However, opponents, including Missouri’s attorney general, express concerns about the lack of in-person medical supervision and potential risks associated with self-managed abortion.

Missouri has enacted restrictive abortion laws in recent years, reflecting broader national debates over abortion rights and access. The state’s legal challenge against the FDA’s generic mifepristone approval represents a new front in efforts to regulate medication abortion.

The lawsuit seeks to revoke the FDA’s authorization of the generic pill, aiming to limit its availability in Missouri and potentially influence national policy. Legal experts note that the case could prompt further judicial review of the FDA’s regulatory authority over abortion medications.

The FDA has not yet issued a public response to the lawsuit. Meanwhile, healthcare providers and reproductive rights advocates have expressed concern that legal challenges to medication abortion could restrict access to safe and effective reproductive healthcare options.

As the case proceeds, it may contribute to ongoing discussions about the balance between drug safety oversight and access to reproductive health services in the United States.