FDA’s regulation of medication abortion must be guided by science, not politics.
Erectile dysfunction drugs have a mortality rate nearly four times greater than Mifeprex, otherwise known as the abortion pill. But despite being less safe, erectile dysfunction drugs are available over the counter at pharmacies. Mifeprex, by contrast, remains one of the U.S. Food and Drug Administration’s (FDA) most heavily regulated drugs—and is even more restricted than fentanyl, an opioid.
This divergence in the regulation of Mifeprex compared to other drugs stems from highly politicized debates over abortion and reproductive rights. FDA’s regulation of Mifeprex, however, should be informed by science, not politics. Despite a demonstrated safety record, Mifeprex remains subject to restrictions that significantly limit its availability to consumers—restrictions that should be reserved for the most dangerous of drugs.
Access to abortion remains one of the most divisive and controversial issues in the United States. As a result, legislators have artificially amplified the risks of Mifeprex. Their pursuit of an anti-abortion agenda has led FDA to allow the political debate surrounding abortion to detract from the established science and evidence of Mifeprex’s safety by overregulating the drug.
When FDA approved Mifeprex for consumers 20 years ago, the agency imposed a set of restrictions known as a Risk Evaluation and Mitigation Strategy (REMS). A REMS typically applies only to drugs that carry the risk of significant complications, such as opioids or antipsychotics. FDA assigns a REMS when the agency deems that the potential risks of a drug outweigh its benefits. Under these restrictions, only a certified health care provider can dispense Mifeprex during a patient’s in-person visit to a clinic or hospital.
REMS restrictions also dissuade physicians from making Mifeprex available when patients request it and could benefit from it. Because only certified health care providers can prescribe the drug and it is unavailable through retail pharmacies or by mail, physicians must stock the drug in their clinics by registering with an FDA-designated distributor on a publicly available list. Given the widespread violence against abortion providers, many physicians have been hesitant to register out of fear of retaliation.
In addition, FDA’s REMS restrictions are especially burdensome on patients living in rural or medically underserved areas. These patients often travel long distances, sometimes thousands of mile in each direction, just to secure a prescription and retrieve their pills.
Similar to other prescription medications, Mifeprex does have potential risks. These risks, such as abdominal cramping, bleeding, and discomfort, are well known—and they are far less serious than the risks from a surgical abortion, pregnancy, or childbirth.
In addition, FDA’s assessment overstates the potential risks of Mifeprex, and complications from the drug are rare. Compared to surgical abortions that occur later in pregnancy, medication abortions take place within the first twelve weeks of gestation and are 92 to 95 percent effective, making them a safer, less intrusive option for patients seeking to terminate their pregnancies. Medication abortion also allows patients to recover in the privacy of their homes. In one study, only 0.1 percent of patients were admitted to the emergency room following a medication abortion, and their complications were minor and expected. Rates of hospitalization due to medication abortion-related complications are similarly rare, ranging from 0.04 percent to 0.3 percent.
Some pro-life physicians and advocacy groups, such as the American Association of Pro-Life Obstetricians and Gynecologists, argue that Mifeprex is dangerous and poses the risk of widespread complications and potentially fatal side effects. These advocates claim that Mifeprex’s potential hazards endanger the lives and health of patients who use the drug, and justify more stringent regulation to protect the health and safety of consumers.
But pro-life groups inflate the risks they advance. According to a recent FDA report, only 24 out of 3.7 million patients who have used Mifeprex died due to potential drug-related complications since the drug received approval 20 years ago. FDA further states that there is no direct link between these recorded deaths and Mifeprex—in fact, nearly half of the 24 total fatalities were not causally linked to the drug but due to unrelated external factors. By contrast, Tylenol accounts for an estimated 458 deaths from liver failure in the United States every year, but it is not subject to similar REMS restrictions that regulate Mifeprex.
Amid COVID-19, abortion rights advocates have voiced new concerns about FDA’s restrictions on access to Mifeprex. In 2020, a federal district court judge ruled that FDA’s in-person clinic visit requirement for patients “posed an undue burden” on pregnant people seeking abortions during the pandemic. The ruling allowed for providers to dispense the pill temporarily through telemedicine due to social distancing concerns. In response, the Trump Administration filed an emergency motion with the U.S. Supreme Court to halt the district court’s decision from going into effect.
Despite overwhelming evidence of the pill’s safety, politics continues to inform Mifeprex regulation more than science. In a 6-3 decision this month, the Supreme Court granted the Trump Administration’s motion to reinstate FDA’s in-person requirements for obtaining Mifeprex for medication abortions. In light of the Court’s decision, advocates are looking to the new Biden Administration to end FDA’s unnecessary restrictions on access to Mifeprex.
Although the future of Mifeprex may remain uncertain, it is long past time for science, not politics, to take the lead in regulating the drug.