The Availability and Use of Medication Abortion Care in the United States

Medication abortion, also known as medical abortion or abortion with pills, is an FDA approved pregnancy termination protocol that involves taking two different drugs, mifepristone and misoprostol, for use up to the first 70 days (10 weeks) of pregnancy. Mifepristone is a progesterone receptor agonist that works by blocking the supply of the hormone that maintains the interior lining of the uterus. Misoprostol is then ingested 24-48 hours later to complete the abortion process. Studies show that medication abortion care is safe and effective.

Medication abortion accounts for more than half (54%) of all abortions before nine weeks gestation in the United States and is now used in nearly two-thirds of abortions in the U.S. Restrictions on the pill are not supported by most major medical societies, including the American Medical Association.

Regulatory History and Drug Approval

Mifepristone was first approved in 2000 for use in combination with misoprostol. Under its original risk evaluation and mitigation strategy program from 2011, mifepristone was required to be dispensed in person by a doctor or under the supervision of a physician at a hospital or clinic. Revisions in 2021 and 2023 expanded the window of use from up to 7 weeks to up to 10 weeks of pregnancy and broadened distribution to include certified pharmacies and telehealth prescribing, with the pills delivered by mail.

Telemedicine and Access Barriers

On April 12, 2021, the FDA’s Center for Drug Evaluation and Research notified the American College of Obstetricians and Gynecologists (ACOG) that they are suspending enforcement of the Risk Evaluation and Mitigation Strategy (REMS) requirement for mifepristone that requires prescribers to dispense to patients in-person during the COVID-19 emergency. This temporarily allows providers in the 32 states and DC that do not have laws that otherwise ban this practice to dispense mifepristone using the telehealth protocol for medication abortion. However, access to mifepristone is restricted across large sections of the country because of state laws that ban abortion or impose separate restrictions on the drug's use.

Legal Challenges and Judicial Rulings

On Friday, a federal judge in Texas ruled to invalidate the FDA’s 23-year-old approval of the abortion pill mifepristone in an unprecedented move. No federal court has ever “second-guessed the science” behind the US Food and Drug Administration’s approval of a medication until now. Just an hour after Judge Kacsmaryk ruled on this case, another federal judge in Washington state issued what seems like a contradictory ruling in a separate case.

The Department of Justice immediately filed an intent to appeal, calling the decision “extraordinary and unprecedented.” President Joe Biden stated that the court in this case has substituted its judgment for FDA, the expert agency that approves drugs. If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.

Broad Impact on Healthcare and BioPharma Industry

While for now the target is abortion care, this ruling could reverberate far beyond one drug. More than 400 executives from the pharmaceutical industry have signed on to a statement condemning the ruling, writing that it “creates uncertainty for the entire biopharma industry.” Nicole Huberfeld, a professor of Health Law, says, “You could see the same thing play out in debates over vaccines or other medications.”

Some states, including Massachusetts, have taken preemptive steps to stock up on the two drugs required for medical abortions. Governor Maura Healey said the state put in an order for close to two years’ worth of mifepristone before the decision even came out. Still, the ruling rattled many, with critics describing recent reviews as the first step in banning abortion nationwide.