The nation’s most restrictive abortion law took effect in Texas on Sept. 1. Later that day, in a near-midnight 5-4 ruling on the troubling “shadow docket,” the Supreme Court refused to block the law, despite acknowledging “serious questions” about its constitutionality.
The legislation is the latest in the ongoing attack on reproductive rights, deeply troubling on many levels, including its blatant violation of Roe v. Wade.
The law bans abortion after a doctor detects a fetal heartbeat, typically around six weeks’ gestation, before many people know they are pregnant. The only exception is an ambiguous and undefined “medical emergency.” Physicians are left to decide whether a patient qualifies for the exception, knowing they could be sued by anyone who disagrees — because the law is enforced by citizens, awarding them at least $10,000 for each abortion prohibited.
As Texas and the nation grapple with the consequences of this law — and similar state laws expected to follow — it is imperative to use every available tool to increase access to safe abortion. One such tool is abortion via pill. But for too long, the Food and Drug Administration (FDA) has retained unnecessary restrictions on medication abortion that harm, rather than protect, pregnant people.
The federal government is stepping up in other ways to fight the Texas law and support reproductive rights — including pledging to protect those seeking reproductive health care and suing the state of Texas. The FDA can also act by easing or eliminating the unjustified medication restrictions.
Mifepristone, also sold under the brand name Mifeprex, is approved by the FDA in a regimen with misoprostol to terminate a pregnancy through 70 days’ gestation. Mifepristone, however, is only available through a restricted program called a “Risk Evaluation and Mitigation Strategy.” Among other things, a patient must obtain the drug from a provider certified with the program and the drug can only be dispensed in certain health-care settings, such as clinics, medical offices, and hospitals. As a result, mifepristone cannot be obtained in retail pharmacies or through the mail, although patients can take the pills anywhere.
The American College of Obstetricians and Gynecologists (ACOG) challenged these restrictions during the pandemic because they subject patients to unnecessary risks of contracting COVID-19 by requiring them to travel to an authorized site to obtain the medication in person. The FDA retained this requirement for mifepristone during the pandemic despite waiving other in-person requirements, such as in-person blood or imaging tests before being prescribed certain drugs, and allowing physicians to use telemedicine in lieu of in-person evaluations before prescribing certain controlled substances, including powerful opioids.
On Jan. 12, the Supreme Court, again using the shadow docket, allowed the FDA to continue enforcing the requirements. Fortunately, the FDA later informed ACOG that it would “exercise enforcement discretion” during the public health emergency regarding the in-person dispensing requirements. Effectively, this allowed providers in states without laws that otherwise ban this practice to dispense medication abortion using telehealth protocols.
The FDA is reviewing the restrictions in response to a lawsuit from the American Civil Liberties Union and should expedite this review. Restrictions on dangerous drugs are often necessary and justified, but evidence from trials and real-world use shows that mifepristone is not dangerous. Mifepristone is safer than many medications not subject to similar restrictions, including Viagra and penicillin. These harmful restrictions lack a medical basis and disproportionately impact low-income populations, communities of color, and people living in rural or underserved areas.
Admittedly, easing these restrictions will not help pregnant people in states like Texas that have their own restrictions, some more restrictive than the FDA’s. According to the Guttmacher Institute, in addition to requiring in-person dispensing, 32 states require providers who administer medication abortion to be physicians. Nineteen states require the clinician providing a medication abortion to be physically present when the medication is administered. The Texas legislature is awaiting Gov. Greg Abbott’s signature on another severe abortion law, which would limit mifepristone use from 70 to 49 days’ gestation.
Even if the FDA relaxes the restrictions, the full spectrum of abortion care remains essential. Nonetheless, it is time for the FDA to send an overdue message about the safety of mifepristone and relax or remove the restrictions. If the FDA truly “follows the science” and believes in its mission to protect and promote public health, it must expedite this review and act as soon as possible.
Allison M. Whelan is a Sharswood fellow at the University of Pennsylvania Carey Law School.