HHS to Review Abortion Pill Rules, Raising Fears of New Restrictions

In the final weeks of September, Health and Human Services Secretary Robert F. Kennedy Jr. announced that the Food and Drug Administration will undertake a new review of mifepristone, the abortion pill utilized in nearly two-thirds of all U.S. abortions. 

The decision comes in response to requests from 22 Republican attorneys general and has raised concerns among abortion rights advocates that the review may lead to nationwide restrictions.

Medical abortion, utilizing mifepristone in conjunction with misoprostol, has emerged as the predominant method for terminating early pregnancies. It is a significant alternative in states with bans on surgical abortions, frequently obtained via telehealth and "shield laws" that permit out-of-state providers to legally mail medications.

In correspondence with the Republican attorneys general, Kennedy and FDA Commissioner Marty Makary stated that the agency would undertake “its review of the evidence, including real-world outcomes and evidence, regarding the safety and efficacy of the drug.” They asserted that a comprehensive investigation into the safe administration conditions of mifepristone adequately safeguards women's health.

Republican officials and anti-abortion organizations have called on the Trump administration to impose stricter regulations on the drug, potentially restricting telehealth prescriptions or reducing the duration of use. Restrictions of this nature could markedly diminish abortion access in at least 16 states that currently ban nearly all in-person abortions.

The impetus for review arises in part from a study conducted by the conservative Ethics and Public Policy Center, referenced by Kennedy and Makary, which asserted that 11% of women utilizing mifepristone encountered “serious adverse events.” This figure notably differs from the FDA's data, which indicates a complication rate of 0.5%. Critics highlight that the study lacked peer review and was solely published on the group's website.

Kiki Freedman, CEO of Hey Jane, the largest telemedicine abortion provider in the nation, stated, “This review could undermine access to one of the most thoroughly studied and widely used medications in the country.” Planned Parenthood cautioned that this action may undermine decades of secure access. Danika Severino Wynn, vice president of care and access at Planned Parenthood Federation of America, stated that mifepristone has been utilized safely and effectively for 25 years.

Kennedy has not indicated whether the review will lead to new restrictions. However, he previously described the conservative study as “alarming” and expressed a desire for a “complete review” of the drug’s safety.

Mifepristone, approved in 2000 and expanded for use through 10 weeks’ gestation in 2016, demonstrates a 97% efficacy when administered in conjunction with misoprostol, as reported by a study from the University of California, Davis. The FDA asserts that mifepristone is both safe and effective when utilized according to established guidelines.