Senator Josh Hawley, a Republican from Missouri, has unveiled a new legislative initiative targeting mifepristone, a widely used abortion pill. This bill seeks to revoke the FDA’s approval of the drug, highlighting growing concern among some lawmakers regarding its safety. Hawley previously proposed similar legislation aimed at banning the drug altogether and allowing women to hold manufacturers accountable for what he describes as an “inherently dangerous” medicine.
The bill, dubbed the Safeguarding Women from Chemical Abortion Act, was presented in the Senate on Tuesday. Hawley firmly believes that the dangers associated with mifepristone warrant immediate action. “The science is clear: The chemical abortion drug is inherently dangerous to women and prone to abuse,” he stated. His comments underline a broader call to prioritize the health and safety of women by restricting access to mifepristone.
Aiming to further highlight the potential risks, Hawley’s legislation seeks to classify the distribution of mifepristone for abortion purposes as illegal under federal law. If passed, this would mark a significant shift in how the drug is regulated in the U.S. The Guttmacher Institute reports that as of 2023, mifepristone was used in 63% of all abortions across the country, making its status a focal point of ongoing debates about reproductive health.
Concerns over mifepristone’s safety aren’t new for Hawley. Last May, he introduced a measure directing the FDA to impose stricter safeguards around its distribution, aimed at enabling women with adverse reactions to seek recourse. His push aligns with a study from the Ethics and Public Policy Center, which revealed troubling data regarding mifepristone’s side effects. The research indicated that the incidence of serious negative outcomes is significantly higher than what the FDA’s label suggests. Alarmingly, over 10% of women reported experiencing severe complications such as infection and hemorrhaging.
To further understand the risks, Hawley has consistently urged the FDA to review ongoing data related to the drug. In a letter addressed to FDA Commissioner Marty Makary, he referenced a commitment from Makary during his Senate confirmation to assess the complete data concerning mifepristone. Hawley pressed that this was critical for maintaining safeguards protective of women’s health. “The health and safety of American women depend on it,” he asserted, emphasizing the urgency and importance of this issue.
Under the Biden administration, the regulatory landscape around mifepristone changed. The FDA began allowing prescriptions via telehealth services, a move meant to enhance access, but one that has also raised safety concerns. In light of these developments, the debate around mifepristone continues to intensify.
Earlier this year, the Supreme Court upheld the legality of mifepristone, reaffirming the FDA’s authority over drug approvals. The court’s ruling dismissed a challenge regarding the drug’s safety based solely on the plaintiffs’ inability to establish legal standing to contest the FDA’s decision. As a result, mifepristone remained available through telehealth consultations and mail orders. This ruling did not, however, engage with the underlying questions regarding the safety of the abortion drug—an omission that Hawley and other critics are keen to address.
As Hawley moves forward with his current legislation, it reflects a significant chapter in the ongoing discussions surrounding abortion rights and women’s health. The potential implications of withdrawing FDA approval for mifepristone would reshape access to abortion services and may lead to further legal and political battles.
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