Introduction

After sustained external pressure on the Trump administration from anti-abortion extremists and lawmakers, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. asked then-FDA Commissioner Marty Makary to “review” the latest data on mifepristone in the fall of 2025. Unsatisfied, anti-abortion advocates claimed the “review” was not moving fast enough, and in May 2026, Makary was removed as Commissioner, at least in part due to these objections. Just hour after being appointed Makary’s temporary replacement, Acting Commissioner Kyle Diamantas called anti-abortion leaders to assure them of his moral opposition to abortion and confirm he would take action to assess the status of this “review.”

In his latest concerning overture to anti-abortion activists, in August 2026 President Trump nominated his Deputy Assistant for Domestic Policy, Heidi Overton, to the role of FDA Commissioner. Overton has called for onerous restrictions on mifepristone despite decades of robust evidence showing it is safe and effective, and anti-abortion advocacy groups are celebrating her nomination.

FDA “review” of the abortion pill

What is the FDA doing to “review” the abortion pill?

FDA has announced publicly that it is conducting a “safety study” of mifepristone; specifically:

“As of April 2026, the FDA continues to work on the collection of the robust and timely data that is necessary for a well-controlled study with adequate statistical power. The next steps of the mifepristone safety study will be data exploration, evaluation of data integrity, and implementation of the analyses, validation, and peer-review. Once the FDA finishes its analysis of the data, the agency will decide whether to make substantive changes to the [risk evaluation and mitigation strategy] REMS [for mifepristone]. If the FDA determines that changes to the REMS are warranted, then the agency will take appropriate action.”

This so-called “safety study” has nothing to do with science or safety. Mifepristone has a 25-year safety track record, and prescription of mifepristone is already heavily regulated and subject to ongoing, routine safety monitoring. Generally speaking, FDA does not conduct its own clinical studies but is instead best positioned to conduct reviews of existing data from external studies. The Trump administration appears to have seized upon the opportunity presented by the publication of a thoroughly debunked, self-published position paper peddled by anti-abortion extremists. To date, neither HHS nor the FDA has provided any clarity or transparency regarding the basis of agency “review” of mifepristone or the data sources they are using to conduct this “review,” despite repeated calls from the public, including from the Center and other advocacy organizations, as well as from Congress.

Significance for mifepristone access

What does this “review” mean for mifepristone?

FDA ultimately makes decisions about the safety and efficacy of drugs approved for use in the U.S. Unfortunately, it is hard to predict with any specificity what could come of FDA’s “review.”

Based on mifepristone’s robust 25-year safety record, there is no justifiable reason for imposing more restrictions on mifepristone if a purely scientific review, protected from political interference and based on FDA’s own regulations and guidelines, was occurring at the FDA. In fact, multiple courts have recently found that FDA had not justified its existing, restrictive regulations on mifepristone and directed the agency to reconsider them.

In this highly politicized, norm-shattering environment, any outcome is possible—especially if, as HHS Secretary Robert F. Kennedy stated in congressional testimony, the agency will ultimately defer to President Trump’s decision making, rather than the scientific and medical analysis of FDA experts.

What’s next?

What’s next?

Due to a ruling in the ongoing litigation in Louisiana v. FDA, FDA will be required to file a status report on the review’s progress no later than October 7, 2026. FDA’s website notes that, as of April 2026, while studies like these often take approximately a year or more to conduct, “the current agency plan is to have this study done sooner than that timeframe.”