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

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 that have repeatedly affirmed and enhanced the safety of mifepristone. On March 26, 2024, the U.S. Supreme Court will hear oral arguments in this case, which poses a direct threat to the safety, availability, and use of mifepristone in the United States. 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.

Understanding the Mifepristone Regimen

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. Mifepristone is used in combination with misoprostol, which is taken to stimulate the emptying of the uterus. 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.

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. 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.

The FDA Regulatory Process and REMS

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. The Risk Evaluation and Mitigation Strategy (REMS) program is a drug safety and regulatory program established by the FDA in response to the Food and Drug Administration Amendments Act of 2007. The REMS requires certain medications to undergo additional evaluation for safety concerns and makes them subject to restrictions on how they can be dispensed.

In response to new research, the FDA has reevaluated the safety of mifepristone at least four times—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.

Key Data on Mifepristone Safety

• Research History: More than 100 studies affirming safety in the past 30 years.
• Patient Safety: Less than 1 percent experience serious side effects.
• Comparative Risk: Fewer serious risks than penicillin or Viagra.
• Prevalence: Accounts for more than half of all abortions in the United States.
• FDA Reevaluations: Safety reevaluated at least four times based on new research.

The Implications of Alliance for Hippocratic Medicine v. FDA

The Alliance case not only threatens to disrupt and stop abortion access nationwide but also represents an attempted upheaval of the regulatory process for all drug approvals by the FDA. 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. The FDA, not the judiciary, is tasked with determining the safety of drugs, as it has the expertise to do so. It’s critical that drug approvals be based on science and safety, not politics.