Senator Josh Hawley, a Republican from Missouri, introduced new legislation on Tuesday aimed at completely removing the abortion drug mifepristone from the American market. The bill, titled the "Safeguarding Women from Chemical Abortion Act," represents one of the most assertive congressional efforts to date targeting the widely utilized pill. If enacted, the legislation would formally rescind the Food and Drug Administration's (FDA) authorization of mifepristone, which has allowed its legal availability since 2000, and classify its distribution for abortion purposes as a direct violation of federal law.
"The science is clear: The chemical abortion drug is inherently dangerous to women and prone to abuse. Yet major companies like Danco Laboratories are making billions off it." — Senator Josh Hawley, Republican-Missouri
Beyond prohibiting the drug, the proposed legislation also seeks to establish a legal avenue for women who allege harm from mifepristone to file civil lawsuits against its manufacturers. Senator Hawley articulated his rationale in a statement to Fox News Digital, asserting, "The science is clear: The chemical abortion drug is inherently dangerous to women and prone to abuse. Yet major companies like Danco Laboratories are making billions off it." He further emphasized the urgency of congressional action, stating, "That’s why I am introducing new legislation to ban the use of mifepristone for abortion and empower women to sue its manufacturers. Congress must act now to protect the health and safety of women."
Mifepristone plays a significant role in abortion care in the United States. According to data from the Guttmacher Institute, a nonprofit research organization, mifepristone was used in 63% of all abortions performed in the country in 2023. The institute estimates that 1,038,100 clinician-provided abortions occurred in 2024, though this figure reflects only states without abortion bans and excludes procedures conducted outside the formal healthcare system.
Senator Hawley's current bill expands upon earlier legislation he introduced in May, which sought to direct the FDA to implement new safeguards for mifepristone and grant women who experienced complications the right to pursue damages against telehealth providers and pharmacies. His frustration with the pace of the FDA's safety review process has been a recurring theme in his legislative efforts concerning the drug.
Concerns regarding mifepristone's safety have been highlighted by various groups. A study conducted by the Washington, D.C.-based Ethics and Public Policy Center (EPPC) found that the rate of adverse side effects from mifepristone was 22 times higher than what the FDA's approved drug label indicates. This research, drawing conclusions from 865,727 insurance claims filed between 2017 and 2023 by women who used mifepristone to end early pregnancies, also found that more than 1 in 10 women reported experiencing "infection, hemorrhaging, or another serious or life-threatening adverse event" after taking the drug. Under current FDA guidelines, mifepristone may be taken up to 70 days since the first day of a woman's last menstrual period.
The FDA's regulatory approach to mifepristone has evolved. During the Biden administration, the agency expanded access to the drug by permitting its prescription through telehealth services and removing the requirement for patients to visit a doctor in person before obtaining it. In 2024, the Supreme Court unanimously declined to reverse the FDA’s expanded approval, but this ruling was solely based on whether the challengers, the Alliance for Hippocratic Medicine, possessed legal standing to bring the case. The justices did not issue a judgment on the drug's safety or merits.
Senator Hawley has previously engaged with the FDA on this issue. He wrote to FDA Commissioner Marty Makary, referencing commitments made during Makary's Senate confirmation hearing. In his letter, Hawley reminded the Commissioner of his pledge to "review the totality of the data and ongoing data" to inform action on the drug. Hawley urged Makary to "follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone," emphasizing that "The health and safety of American women depend on it."
The legislative effort is not confined to the Senate. Congresswoman Diana Harshbarger, a pharmacist by profession, announced plans to introduce companion legislation in the House of Representatives this week, indicating a coordinated push to address the availability and regulation of mifepristone. The introduction of this bill is expected to ignite significant debate on Capitol Hill, impacting discussions around reproductive healthcare access, pharmaceutical regulation, and women's health policy.
