Federal Lawmakers Introduce Bill to Revoke FDA Approval of Mifepristone

U.S. Sen. Josh Hawley filed legislation this week that would undo federal approval of mifepristone, a key abortion drug, nationwide. Congresswoman Diana Harshbarger introduced companion legislation in the House.

Hawley's bill would direct the U.S. Food and Drug Administration to withdraw its approval of mifepristone to terminate pregnancies, make distributing the drug a violation of federal law and allow women to sue abortion drug manufacturers. The legislation would also make distributing and labeling mifepristone for pregnancy termination violations of the Federal Food, Drug, and Cosmetic Act.

The FDA is conducting a review of mifepristone, a drug the agency approved more than 25 years ago. Republican attorneys general from Louisiana, Missouri, Idaho, Kansas, Florida and Texas have sued the federal government and asked the courts to prohibit the pill from being prescribed through telehealth, among other restrictions. The Department of Justice has sought to delay these lawsuits — or dismiss them entirely — arguing that the litigation is interfering with the FDA's review of mifepristone.

A pending request in the Louisiana case for an injunction on telehealth abortion care, if granted, could limit access nationwide, at least temporarily.

Major anti-abortion groups endorsed Hawley's legislation this week, including the Ethics and Public Policy Center. The conservative think tank published a non-peer reviewed paper in April that said nearly 11% of people who took abortion medication ended up experiencing serious adverse events, though there's dispute over how that's defined in the paper. The FDA's label for Mifeprex — a brand of mifepristone — states that serious adverse effects were reported in less than 0.5% of women.

In January, researchers at Johns Hopkins University published a study reviewing the documents the FDA used when assessing mifepristone's regulations from 2011 to 2023. The authors concluded that the agency based its decisions on scientific evidence instead of ideological bias and acted with caution when widening the drug's availability.

Health and Human Services Secretary Robert F. Kennedy Jr. ordered a review of mifepristone a few weeks after the Ethics and Public Policy Center paper's publication and told Hawley the findings were "alarming" during a Senate hearing.

The drug accounted for 63 percent of all abortions in the country in 2023, according to the Guttmacher Institute. Telehealth medication abortion prescribed by providers in states with shield laws accounted for 27% of all abortions provided during the first half of 2025, according to the Society of Family Planning's latest #WeCount report.

In the states, Republican lawmakers have honed in on limiting the availability of abortion medication, the most common way to terminate early pregnancies in the U.S. Legislation that would open the door to an avalanche of lawsuits against abortion providers and drugmakers await governors' signatures — or vetoes — in Mississippi and South Dakota.

Currently, medical abortions are completely banned in 14 states, and access to mifepristone is restricted in an additional 10 states. The most effective and safest medical regimen for terminating a pregnancy in the first trimester is a combination of two medications: mifepristone and misoprostol. Together, they can induce a complete abortion with minimal complications in 95 percent to 98 percent of pregnancies.

A recent study published in JAMA analyzed 31,977 patients who experienced an early pregnancy loss on either the dual therapy or misoprostol alone; in the misoprostol-only therapy, there was both a higher rate of subsequent uterine aspiration (14 percent versus 10.5 percent) and a higher rate of emergency department visits (7.9 percent compared to 3.5 percent).