The FDA’s Decisions on Mifepristone Have Advanced the Safety of Medication Abortion

Mifepristone is part of a two-step regimen approved for medication abortion, which is now the most common form of abortion care in the United States. Notably, this regimen accounts for more than half of all abortions in the United States and has a long record of safety and effectiveness, with more than 100 studies affirming its safety in the past 30 years. Mifepristone is the first medicine in a two-step regimen for early abortion care. It works by blocking the hormone progesterone, which is needed for a pregnancy to continue, and is used in combination with misoprostol, which is taken to stimulate the emptying of the uterus.

Regulatory Oversight and the REMS Program

The U.S. landscape of abortion care has undergone a significant transformation since the FDA’s initial approval of mifepristone in September 2000, which enhanced both the safety and accessibility of medication abortion. Among those changes were updates to the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program and the product label following rigorous reviews guided by scientific evidence and medical consensus. The Risk Evaluation and Mitigation Strategy (REMS) program is a drug safety and regulatory program established by the FDA which requires certain medications to undergo additional evaluation for safety concerns and makes them subject to restrictions on how they can be dispensed.

The FDA has reevaluated the safety of mifepristone at least four times in response to new research—each time concluding that it is safe. Mifepristone has always been safe and effective, and each time the FDA has implemented a REMS or product label update, it has reaffirmed that the drug is one of the safest drugs available on the market. Furthermore, research shows that less than 1 percent of patients experience serious side effects when using mifepristone and that mifepristone has fewer serious risks than penicillin or Viagra.

Key Safety and Research Statistics

• Serious Side Effects: Occur in less than 1 percent of patients.
• Safety Benchmarking: Fewer serious risks than common medications like penicillin or Viagra.
• Scientific Evidence: More than 100 studies affirming safety over the past 30 years.
• Regulatory History: Reevaluated at least four times with consistent safety confirmations.

The Legal Challenge: Alliance for Hippocratic Medicine v. FDA

The U.S. Supreme Court is preparing to hear Alliance for Hippocratic Medicine v. Food and Drug Administration, an unprecedented case on medication abortion that threatens to roll back years of scientific progress by undermining FDA decisions. On March 26, 2024, the U.S. Supreme Court will hear oral arguments in this case that poses a direct threat to the safety, availability, and use of mifepristone in the United States.

In Alliance, the Supreme Court will review the FDA’s decisions regarding how mifepristone is labeled and distributed, including restrictions that the FDA lifted in previous years after rigorous reviews and research finding that the drug is safe and effective. The case calls into question the FDA’s integrity as a regulatory body and could undermine its authority and purpose as an institution designed to protect public health and safety. Ultimately, it’s critical that drug approvals be based on science and safety, not politics, as the FDA, not the judiciary, is tasked with determining the safety of drugs.

Moreover, medication abortion with mifepristone gives women and anyone who can become pregnant the option to have privacy and control over their reproductive decisions and bodily autonomy from their preferred space and under the guidance of a health care provider.