Health and Human Services Secretary Robert F. Kennedy Jr. announced this week that the Food and Drug Administration (FDA) will conduct a new review of mifepristone, a medication used for abortions. This decision has raised concerns among abortion rights advocates, who fear it could lead to significant restrictions on medication abortions, which account for nearly two-thirds of all abortions in the United States, according to the Guttmacher Institute.

Medication abortion is particularly important in states where abortion services are heavily restricted. Telehealth appointments and shield laws allow providers in other states to send abortion pills to women in states with bans without facing legal repercussions. Republicans and anti-abortion advocates have been urging the Trump administration to revise the FDA's regulations regarding mifepristone, which is typically used in conjunction with another drug, misoprostol, to terminate a pregnancy or manage an early miscarriage.

If the FDA imposes restrictions on mifepristone, such as banning telehealth access or limiting the time frame in which it can be used, it could severely limit abortion access in the post-Roe v. Wade landscape. Currently, at least 16 states have effectively halted nearly all abortion services.

In a letter to 22 Republican attorneys general who requested the review, Kennedy and FDA Commissioner Marty Makary stated that the FDA would evaluate the safety and efficacy of mifepristone, including real-world outcomes. They wrote, "The concerns you have raised in your letter merit close examination. This Administration will ensure that women's health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed."

A study cited by Republicans and referenced in the response letter was conducted by the Ethics and Public Policy Center, a conservative think tank. This study claimed that nearly 11% of women experienced serious adverse events related to mifepristone, a figure significantly higher than the 0.5% rate reported in clinical studies and noted on the FDA's medication label. However, this study has not undergone peer review and was published on the center's website rather than in a scientific journal.

Kiki Freedman, co-founder and CEO of Hey Jane, the largest telemedicine abortion provider in the U.S., expressed concern about the potential impact of the HHS review. She stated, "The new HHS review could undermine access to one of the most thoroughly studied and widely used medications in the country. HHS Secretary RFK Jr. and FDA Commissioner Marty Makary's threat to conduct their own 'review' of mifepristone underscores the disturbing rise of junk science and politically motivated attacks in shaping public health policy."

Planned Parenthood also responded, highlighting the importance of telehealth in expanding access to abortion care. Danika Severino Wynn, vice president of care and access at Planned Parenthood Federation of America, said, "For 25 years, mifepristone has been used safely and effectively by patients across the country. Recent innovations like telehealth have expanded access to people who would otherwise be unable to get abortion care."

Kennedy, when questioned about the study by Senator Josh Hawley, R-Mo., described it as "alarming" and suggested that the medication's label should be revised. He has requested a complete review of mifepristone from Makary but has not committed to changing access rules.

Mifepristone works by blocking progesterone, a hormone necessary for maintaining a pregnancy. The FDA approved mifepristone, also known by the brand name Mifeprex, for use in medication abortions in September 2000, initially allowing its use up to seven weeks' gestation, which was later extended to ten weeks in 2016. The World Health Organization states that the two-drug regimen can be used up to 12 weeks into a pregnancy. As of 2022, medication abortions represented 57% of all abortions performed in the U.S., a significant increase from 19% in 2011, according to the Centers for Disease Control and Prevention. The FDA maintains that mifepristone is safe and effective when used as directed, with a 97% effectiveness rate when combined with misoprostol.