Hawley Introduces Bill to Restrict Mifepristone Access Following Study on Adverse Effects

Senator Josh Hawley, a Republican representing Missouri, has introduced legislation aimed at scaling back access to mifepristone, a widely used medication for terminating early pregnancies. The move follows the release of a recent study that the senator claims highlights the drug’s potential dangers, citing that a significant percentage of women who use mifepristone experience serious adverse health effects.

The proposed bill, titled the Restoring Safeguards for Dangerous Abortion Drugs Act, seeks to impose stricter regulations on the drug’s distribution and usage. It would direct the Food and Drug Administration (FDA) to implement several safeguards, including allowing women who experience complications after taking mifepristone to sue telehealth providers and pharmacies for damages. Additionally, the bill aims to ban foreign companies from mailing and importing mifepristone into the United States.

Hawley argues that the legislation is necessary to protect the health and safety of American women. He cites a study by the Ethics and Public Policy Center (EPPC), which examined a large dataset of insurance claims. The study’s findings, according to Hawley, demonstrate that mifepristone poses a significant risk to women’s health.

The EPPC study analyzed over 865,000 insurance claims from 2017 to 2023, focusing on women who used mifepristone to terminate early pregnancies. The study concluded that over ten percent of women experienced serious or life-threatening adverse events within 45 days of taking the medication. These events included sepsis, infections, hemorrhaging, and other severe complications.

Mifepristone, approved by the FDA in 2000 under the Clinton administration, is used in conjunction with another drug, misoprostol, to terminate pregnancies up to 70 days after the first day of the woman’s last menstrual period.

The introduction of Hawley’s bill reignites the ongoing debate surrounding abortion access in the United States. While supporters of abortion rights argue that mifepristone is a safe and effective medication, opponents contend that it poses unacceptable risks to women’s health.

The Guttmacher Institute, an organization that formerly operated as part of Planned Parenthood, estimates that over one million clinician-provided abortions occurred in 2024. However, this figure only reflects abortions performed in states without abortion bans and does not include abortions performed illegally or in states with varying restrictions.

The regulation of mifepristone has evolved since its initial approval. The Obama administration’s FDA rolled back some of the original restrictions in 2016, reducing the need for in-person visits, eliminating mandatory physician prescription requirements, and removing the requirement to report non-fatal adverse events.

Hawley has previously expressed concerns about the safety of mifepristone to FDA Commissioner Dr. Marty Makary. In a letter, Hawley urged Makary to review new data and restore critical safeguards on the use of mifepristone.

The introduction of Hawley’s bill comes amidst ongoing legal battles surrounding mifepristone access. The Department of Justice (DOJ) recently asked a Texas federal judge to dismiss a case that could restrict access to the medication. This stance mirrors a similar position taken by the Biden administration.

The FDA has yet to issue a formal statement regarding Hawley’s legislation or the EPPC study.

The debate over mifepristone access is likely to continue in the coming months, with both sides presenting arguments regarding its safety and efficacy. The outcome of this debate could have significant implications for women’s health and access to abortion care in the United States. The Restoring Safeguards for Dangerous Abortion Drugs Act represents a significant effort to restrict access to the drug, reflecting concerns about its potential adverse effects. The legislation is likely to face strong opposition from Democrats and abortion rights advocates, who argue that it would unduly restrict access to a safe and effective medication. The bill’s future is uncertain, but it is likely to spark further debate about the regulation of abortion drugs and the role of the federal government in regulating women’s health care. The legal challenges surrounding mifepristone suggest the issue will continue to be a point of contention between pro-choice and pro-life advocacy groups, as well as state and federal governments.