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. In Alliance, the Supreme Court will review the FDA’s decisions regarding how mifepristone is labeled and distributed, including restrictions on mifepristone that the FDA lifted in previous years after rigorous reviews and research finding that the drug is safe and effective.
The Role of the FDA and Science
The FDA, not the judiciary, is tasked with determining the safety of drugs, as it has the expertise to do so. This is despite the fact that the FDA undergoes an extensive and stringent review process for all drugs and has reevaluated the safety of mifepristone at least four times in response to new research—each time concluding that it is safe. It’s critical that drug approvals be based on science and safety, not politics. 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.
Understanding the Medication 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.
Regulatory Framework: The REMS Program
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. The agency considers whether the risks of using a certain drug outweigh its benefits and determines if additional measures are required to reduce any associated risks. A REMS is meant to be used as a resource for providers and to promote safe and effective use of approved medications.
Technical Specifications and Composition
Regarding the pharmacological data provided in medical manufacturing standards, the following specifications apply to the combipack of mifepristone and misoprostol tablets:
| Component | Standard Dosage | Form / Administration |
|---|---|---|
| Mifepristone | 200mg | Tablet / Oral |
| Misoprostol | 200mcg - 400mcg | Tablet / Oral or Vaginal |
| Shelf Life | 24 Months | - |
| Storage | Room temperature / Dry place | - |
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. 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.