Abortion Pill Mifepristone: An Explainer on History, Safety, and Legal Status

Medication abortion, also known as abortion with pills or medical abortion, is a safe method for the termination of early pregnancy. The National Abortion Federation (NAF), which is the professional association of abortion providers, unites, represents, serves, and supports providers in delivering patient-centered, evidence-based care. As of recent data, medication abortions accounted for 51% of all abortions in the U.S.

Clinical Safety and Effectiveness

The Food and Drug Administration has approved medication abortion for up to 10 weeks of pregnancy and the World Health Organization authorizes its use for up to 12 weeks. Regarding its long-term track record, mifepristone has been used and approved from abortion for 23 years by more than 5 million Americans. Furthermore, the drug has been in used in more than 600 published clinical trials and 800 peer-reviewed medical journals.

The FDA itself has researched mifepristone and determined that serious or adverse events associated with it are “acceptably low.” In fact, the drug is statistically safer than over-the-counter medications such as ibuprofen or popular prescriptions like Viagra. Research shows the following safety statistics:

• Major adverse events: Roughly 0.3%.
• Rate of infection: Pegged at 0.015%.
• Approved usage: 23 years of clinical history.
• Scientific backing: Over 600 clinical trials and 800 peer-reviewed journals.

Supreme Court Rulings and Legal Landscape

On June 13, the Supreme Court justices in a unanimous decision preserved access to mifepristone, writing that “federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.” This followed a period where the legal future of mifepristone had hung in the balance for several months. Previously, in August 2023, the 5th U.S. Circuit Court of Appeals ruled that mifepristone should not be prescribed past the seventh week of pregnancy, prescribed via telemedicine, or shipped to patients through the mail.

Currently, abortion is on the ballot in several states, with initiatives that aim to ban, restrict, or expand abortion rights. It is important to note that state laws that ban abortion apply to both abortion medications and surgical procedures.

Expanding Access via Retail Pharmacies

The Biden administration in January announced that retail pharmacies could dispense abortion pills, part of a broader push to preserve and expand access to abortion. A handful of independent pharmacies across the country have quietly begun dispensing the abortion pill mifepristone under these new rules. This development has the potential to radically alter the landscape, because most people live much closer to their local pharmacy than a doctor’s office or hospital. GenBioPro, the maker of generic mifepristone, published a list of 19 pharmacies in nine states certified to dispense the drug.

Legal Challenges Against FDA Restrictions

A federal lawsuit has been filed in Virginia as the Center for Reproductive Rights has challenged the FDA regarding the way it has handled requirements surrounding mifepristone. The lawsuit argues that the government has put several unnecessary and politically-motivated restrictions on the drug, including the use of the “risk evaluation and mitigation strategy” or REMS system. Plaintiffs argue that by making mifepristone seem unique dangerous, FDA’s continuing restriction of mifepristone stigmatizes medication abortion and contributes to the chaos anti-abortion activists now sow. They are urging the federal government, via a court order, to remove the REMS restrictions that cause additional paperwork and certification.