Introduction

The Food and Drug Administration (FDA) has a responsibility to regulate drugs based on the highest quality science. As attacks on the abortion pill mifepristone continue to grow, the Trump FDA has announced it will “reexamine” the safety of abortion pills—which could be a pretext for instituting new, medically unnecessary restrictions despite the fact that mifepristone has a robust 25 year, proven safety record. This announcement is confounding, in part, because the FDA already continuously monitors the safety of drugs it has approved as part of its regular work. This fact sheet breaks down how drug safety monitoring in the FDA should function.

Before FDA approval

Before FDA approval

Before the FDA approves a drug for use and marketing in the United States, that drug must go through robust safety evaluations by its sponsor—usually the drug developer, or potential manufacturer or marketer—which are then reviewed and double-checked (and sometimes even challenged) by FDA. As part of this pre-approval review, the sponsor and the FDA identify known adverse effects of a drug. Adverse effects are any undesirable experience or injury that may be caused by a drug, including but not limited to serious reactions requiring medical intervention. These adverse effects are the ones you see listed on a medication bottle or box, written on a TV ad, or read in an ad on the radio or a podcast.

After FDA approval

After FDA approval

Not all possible adverse effects of a drug can be anticipated when that drug is approved, so the FDA maintains a system to identify potential safety issues with approved drugs. Its MedWatch program allows both health professionals and consumers to easily report observed or suspected adverse events. Manufacturers are also required to submit reports based on information they receive through the supply chain, like from health care providers. These reports help the FDA develop targeted strategies to mitigate or prevent legitimate safety issues. This information is publicly accessible through a dashboard known as the FDA Adverse Event Monitoring System (AEMS) (formerly FDA Adverse Event Reporting System (FAERS)).

The FDA has a team of people whose job it is to evaluate AEMS data. FDA staff flag significant patterns in the safety reporting data, called “newly identified safety signals” (NISS), in order to determine whether any of the adverse event reports merit further review, evaluation, and/or management. If the FDA’s determination to evaluate the NISS is based on AEMS data (and meets certain other criteria), the FDA will include the drug in a quarterly report to share the safety evaluation information with the public.

In addition to AEMS, the FDA has other sources of information it can and does use to monitor the safety of drugs. For example, the FDA’s active surveillance program, Sentinel Initiative, works with health insurance providers and health care systems to identify safety signals in drugs. The FDA can also request information from federal government facilities providing medical care (e.g., the Veterans Affairs system). If necessary, it can then request additional clinical trial data to answer any new safety questions. The FDA will work with the drug sponsor or other researchers, such as those at the National Institute of Health, to get this data and conduct safety analyses.

Impact on mifepristone

What does this mean for mifepristone?

Mifepristone is one of the most studied and scrutinized medications. In the 26 years since mifepristone’s FDA approval, its safety and efficacy have been confirmed numerous times through the agency’s repeated, rigorous review of the underlying scientific data and literature; the real-world clinical experience of millions of women who have safely used the mifepristone regimen; and the FDA’s own safety monitoring systems. More than 7.5 million women in the United States have used mifepristone safely with adverse events rates the FDA itself characterizes as “extremely rare.”

Hundreds of high-quality studies conducted since mifepristone’s 2000 approval have confirmed its safety and efficacy. Mifepristone has been used in over 600 published clinical trials and discussed in nearly 800 peer-reviewed medical reviews. Anti-abortion extremists are trying to undermine this extensive history by peddling one self-published paper masquerading as scientific research. This paper has been thoroughly debunked.

Due to ongoing pressure from anti-abortion ideologues, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has asked FDA Commissioner Marty Makary to review the latest data on mifepristone. The FDA will have to provide a status update on that review by October 7, 2026, per a recent ruling in the lawsuit Louisiana v. FDA. But any serious, credible review of the data should affirm what we already know based on the best scientific evidence: abortion pills are safe, effective, and widely used.

Impact on reproductive health drugs

What does this mean for other reproductive and maternal health drugs?

Similar to the mis- and disinformation surrounding mifepristone, multiple reproductive and maternal health drugs may be at risk due to questionable and biased safety claims. For example, Tracy Beth Hoeg, the current Acting Director of the FDA’s Center for Drug Evaluation and Research, recently indicated her intent to “study” the safety of certain antidepressants when used during pregnancy, repeating unfounded claims about the potential for birth defects. Professional organizations like the American Psychiatric Association and the American College of Obstetricians and Gynecologists have repeatedly cited research that shows there is no association between prenatal exposure to these medications and overall risk of birth defects. These medical organizations also highlight the importance of antidepressants to address mental health problems that pregnant people may face, especially since mental health conditions are a frequent cause of pregnancy-related death.

Conclusion

Conclusion

The FDA must remain steadfast in its mission to promote and protect public health based on rigorous scientific research and data that is free from mis- and disinformation, partisan pressure, and political bias. The Center will continue to hold the FDA accountable to ensure that it does not inappropriately or illegally restrict access to life-saving medication. Learn more about our oversight work.