Twenty-five years ago, the United States Food and Drug Administration (FDA) approved Mifeprex® (mifepristone) as a safe and effective option for terminating pregnancy up to seven weeks (approval later extended to 10 weeks). The Population Council conducted the clinical trials and submitted the application to the FDA that led to this approval—a major contribution for health care access and reproductive choice in the US.
The FDA’s recent announcement that it would review mifepristone’s safety and how the drug can be administered—despite its previous approval and subsequent decisions that expanded access via telehealth—revisits decades of research from the US and globally that overwhelmingly shows the drug is safe and effective. The study that is cited as prompting the FDA’s review—unlike the rigorous research that led to the FDA’s 2000 approval—was not peer reviewed, which is the gold standard for maintaining scientific credibility. Evidence from around the world consistently shows that making abortion care less accessible leads to serious consequences—including more unsafe abortions and increases in health complications and maternal deaths.
Medication abortion—a two-drug regimen that includes mifepristone and misoprostol—has been safely used by more than 7.5 million people since its approval and accounts for nearly two-thirds of abortions in the United States. Last week, the FDA approved a second generic form of mifepristone, underscoring its safety and offering more options for access.
The Population Council stands for scientific integrity, evidence-based policies, and reproductive autonomy, including the right to choose whether, when, or how many children to have. The evidence is clear: medication abortion is a safe, effective, and essential part of comprehensive sexual and reproductive health care.