Food and Drug Administration (FDA) Commissioner Dr. Marty Makary has announced a full agency review of the abortion pill mifepristone, following new research that raises concerns about the drug’s safety. The move comes amid ongoing legal battles and heightened political attention to the role of chemical abortion in post-Roe America.
In a letter sent Monday to Senator Josh Hawley (R-Mo.), a leading pro-life advocate, Makary said the FDA would re-examine the drug’s risk profile and work closely with career scientists to evaluate new safety data.
“As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data,” Makary wrote.
Makary declined to speak further, citing ongoing litigation over mifepristone’s regulation. The drug has remained at the center of heated legal disputes, even after the Supreme Court declined to overturn its FDA approval last year. That case was dismissed on the grounds that the pro-life physicians who brought the suit lacked legal standing. Meanwhile, abortion providers are pursuing lawsuits to ease existing restrictions on prescribing mifepristone.
New Study Sparks Safety Concerns
The FDA’s decision to conduct a new review was prompted in part by a study from the conservative Ethics and Public Policy Center (EPPC), which claims that mifepristone may be significantly riskier than previously acknowledged. The study, based on an insurance claims database of over 865,000 women who received mifepristone between 2017 and 2023, reported that nearly 11 percent experienced serious adverse events — including hemorrhage, infection, and sepsis — within 45 days of taking the drug.
This figure, the EPPC says, is 22 times higher than what the current FDA labeling suggests.
“I’m calling on the FDA to reinstate safety regulations on the chemical abortion drug immediately,” Senator Hawley said. “New data out today show a massive number of severe medical side effects.”
A separate report from the pro-life Charlotte Lozier Institute challenged longstanding claims from abortion-rights advocates that mifepristone is safer than over-the-counter drugs like Tylenol, calling those comparisons misleading.
President Trump Faces Pressure from Pro-Life Groups
President Donald Trump, who returned to the White House after winning re-election in 2024, has taken a cautious position on abortion policy. While supportive of the Supreme Court’s 2022 reversal of Roe v. Wade, Trump has avoided endorsing sweeping federal abortion bans and has resisted calls to restrict access to mifepristone.
During the 2024 campaign, Trump sought to strike a balance between pro-life advocacy and public opinion, which largely opposes total abortion bans. He pledged not to interfere with access to abortion pills, a stance that disappointed many in the pro-life movement.
Now, with new safety data emerging, pro-life leaders including Senator Hawley are urging the Trump administration to reconsider its hands-off approach to chemical abortion.
“The president has a responsibility to protect women’s health,” Hawley said. “This new information about mifepristone cannot be ignored.”
Chemical Abortions on the Rise
Despite the post-Roe legal environment, medication abortions have become increasingly common. According to the Guttmacher Institute, a research organization that supports abortion access, chemical abortions accounted for 63 percent of all U.S. abortions in 2023 — a 10 percent increase since 2020.
Mifepristone, used in combination with misoprostol, has been widely promoted by abortion providers as a safe and convenient option. However, critics argue that FDA policies — including those allowing the drug to be prescribed via telehealth — compromise patient safety.
During his confirmation hearing, Makary expressed concern about the Biden administration’s decision to loosen mifepristone regulations, particularly the removal of the in-person dispensing requirement. He pledged to review the policy, though he stopped short of promising specific action.
What Comes Next?
Makary’s review could take months and will likely include reanalysis of clinical data, consideration of the EPPC study, and input from both FDA scientists and outside stakeholders. While the review does not guarantee regulatory changes, it could lead to updated labeling, revised prescribing guidelines, or reinstatement of restrictions that were lifted in recent years.
The issue is expected to remain politically sensitive as the Trump administration weighs its next steps — and as courts continue to hear challenges on both sides of the abortion debate.
