Bloomberg Law
Nov. 18, 2022, 8:42 PM

Lawsuit Filed Against FDA to Block Access to Abortion Pill (1)

Madlin Mekelburg
Madlin Mekelburg
Bloomberg News

Abortion opponents sued the US Food and Drug Administration on Friday, seeking to overturn the agency’s decades-old authorization of a pill that induces abortions.

The lawsuit, filed in federal court in Amarillo, Texas by the conservative legal group Alliance Defending Freedom, claims that the FDA fast-tracked the 2000 approval of the drug called mifepristone using a process intended to authorize treatments for life-threatening illnesses -- and did so without sufficient scientific evidence in favor of approval.

“The FDA failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States,” the lawsuit reads. “And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.”

Research has found that medication abortion, the most common way to terminate a pregnancy in the US, is safe and effective. The FDA has put additional guardrails on prescribing the pill, which major medical bodies have argued are unnecessary. It’s currently approved for use for up to 10-weeks of pregnancy

Dozens of states have adopted restrictions on access to the medication that go beyond FDA regulations. That includes Texas, where the drug is banned after seven weeks of pregnancy and cannot be mailed to patients.

Friday’s lawsuit is the latest challenge to abortion access in the wake of the US Supreme Court’s decision to overturn its landmark Roe v. Wade decision and allow states to set limits on the procedure. The FDA declined to comment on the pending litigation.

The case is Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, 2:22-cv-00223, US District Court, Northern District of Texas (Amarillo).

(Adds FDA response and details about restrictions on access to the medication)

To contact the reporter on this story:
Madlin Mekelburg in Austin at

To contact the editors responsible for this story:
Katia Porzecanski at

Rebecca Greenfield

© 2022 Bloomberg L.P. All rights reserved. Used with permission.

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