Hawley bill to end FDA approval mifepristone picks up Senate GOP support

Sen. Josh Hawley’s (R-Mo.) bill to revoke the Food and Drug Administration’s (FDA) approval of the drug mifepristone for use in terminating pregnancies is picking up Senate Republican support, as the push to stop its shipment across state lines is becoming a top priority of the anti-abortion movement.  

Hawley’s bill, which would make distributing and labeling mifepristone for abortions a violation of the Food, Drug and Cosmetic Act, has quickly picked up the support of three other GOP senators: Sens. John Cornyn (Texas), Ted Budd (N.C.) and Marsha Blackburn (Tenn.).

The Safeguarding Women from Chemical Abortion Act would also create a private right of action for women harmed by chemical abortion to sue manufacturers for damages.

Hawley urged Republican senators to support the bill in a “Dear Colleague,” warning that if Congress fails to act, “mifepristone will continue to expose increasing numbers of American women to severe risks.”

He said that the Obama and Biden administration stripped away safety guidelines that the FDA put in place when the drug was first approved under the Clinton administration in 2000.

The FDA approved a second generic mifepristone pill in October, making it more accessible.

“Mifepristone can now be shipped through the mail with the click of a button. Today the drug accounts for 70 percent of abortions in the United States, and at least 7.5 million women in the country have taken it since it was approved in 2000,” Hawley wrote in his letter.

Hawley says the widespread availability of mifepristone has undermined the Supreme Court’s 2022 decision to overturn Roe v. Wade, the landmark 1973 case establishing the nationwide right to an abortion.

He said the court intended to give states the power to restrict abortions but state regulations have been circumvented by the ability of people to order mifepristone through the mail.

“Every pro-life group has endorsed this bill,” Hawley told The Hill. “I think it’s important for two reasons: Number one, it’s focusing attention on the fact that this drug used for abortion causes serious adverse health effects.

“Number two, the drug makers, particularly Danco, are just making profits like you wouldn’t believe and they’re sitting in the Cayman Islands not accountable to anybody,” he said.

Hawley said he hasn’t talked to GOP leadership about holding a vote on the legislation, but he argued “we should vote on this bill.”

“This is the future of the life movement, it’s going to be about mifepristone. Because right now it really doesn’t matter what you pass in the states because mifepristone just gets mailed in. So you can have a [state] law that’s fully protective of life, it doesn’t matter. Abortions go up every year,” he said.

Hawley held a press conference on Capitol Hill earlier this month to highlight the health risks posed to women who take the drug.

“No woman who has suffered from this drug has any meaningful option to recover from the two drug companies who make it, mislead about its effects—and profit from it to the tune of billions of dollars. That should change,” Hawley wrote in his letter to colleagues.

He regularly cites a study of 875,000 mifepristone prescriptions that found in 11 percent of cases women suffered “serious health effects.”

That study by the Ethics and Public Policy Center, however, has been the subject of numerous fact checks disputing its findings.

The FDA estimates the rate of serious adverse effects at 0.5 percent, and KFF notes other studies have reached similar conclusions.

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