FIRST ON FOX: Sen. Josh Hawley, R-Mo., introduced legislation Tuesday to scale back the popular abortion drug mifepristone after a recent study revealed that 1 in 10 women who used the medication experienced “serious adverse effects.”

The Restoring Safeguards for Dangerous Abortion Drugs Act would direct the Food and Drug Administration (FDA) to create safeguards on the abortion drug mifepristone, allow women who have suffered complications from prescriptions the right to sue telehealth providers and pharmacies for damages, and ban foreign companies from mailing and importing mifepristone into the U.S.

Hawley introduced the legislation “after a bombshell study revealed the truth about mifepristone: it’s dangerous,” the Missouri senator told Fox News Digital. “The data shows 1 in 10 women who take mifepristone experience adverse health effects, like going to the ER or suffering from sepsis. The FDA needs to act to protect women now.”

COVID VACCINE BOOSTERS CALLED INTO QUESTION BY FDA CHIEF: ‘VOID OF DATA’

Hawley cites last week’s study by the Ethics and Public Policy Center (EPPC), which revealed in its key findings that “10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious or life-threatening adverse event within 45 days following a mifepristone abortion.”

The study assessed 865,727 insurance claims between 2017 and 2023 for women who used the medication to terminate early pregnancy. The pill can be taken up to “70 days since the first day of their last menstrual period,” according to the FDA.

The exact number of women who have undergone a mifepristone abortion since the FDA’s approval under the Clinton administration in 2000 can be difficult to calculate, as some pregnancies are terminated without official medical intervention. 

The Guttenmacher Institute, a non-governmental organization (NGO) which was once a part of Planned Parenthood, estimates that there were 1,038,100 clinician-provided abortions in 2024, though this number only reflects “states without a ban”. The estimation does not include the number of abortions that occurred illegally or in states where pregnancy termination laws vary.  

SCOOP: REPUBLICANS DISCUSS DEFUNDING ‘BIG ABORTION’ LIKE PLANNED PARENTHOOD IN TRUMP AGENDA BILL

At the time of approval, there were stricter parameters for administering the drug. However, the Obama administration’s FDA rolled back some of these requirements in 2016 by reducing the need for in-person visits, removing mandatory physician prescription requirements, and eliminating non-fatal adverse event reporting. 

Hawley sent a letter last week to Trump-appointed FDA Commissioner Dr. Marty Makary, whom Hawley questioned during the former Johns Hopkins School of Medicine professor’s confirmation before the U.S. Senate.

“[D]uring your confirmation hearing, you pledged to me that you would ‘review the totality of the data and ongoing data’ to inform action on the drug,” Hawley’s letter to the FDA head explained. “I urge you to follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone. The health and safety of American women depend on it.”

TRUMP FOE LETITIA JAMES LEADING CHARGE ON NEW MULTISTATE LAWSUIT OVER HHS CUTS

The introduction of Hawley’s bill comes just one day after Trump’s Department of Justice (DOJ) asked a Texas federal judge to dismiss a case that could restrict access to the controversial pill. This move mirrored a similar stance taken by the Biden administration to keep a mifepristone lawsuit out of a Texas court.

Fox News Digital reached out to the FDA for comment.

Preston Mizell is a writer with Fox News Digital covering breaking news. Story tips can be sent to Preston.Mizell@fox.com and on X @MizellPreston