Why the FDA Must Lift Unnecessary Restrictions on Medication Abortion Care Now


The Democratic congresswomen of the House Oversight Committee are putting pressure on the Food and Drug Administration to lift the in-person dispensing requirement for mifepristone—a prescription medication that’s used to safely end early pregnancies in the United States. During the coronavirus pandemic, safe access to medication abortion is more important than ever, but being required to obtain the medication in person places a burden on individuals. Below, Committee Chairwoman Carolyn Maloney and Committee Member Ayanna Pressley explain how onerous these restrictions really are and urge the FDA to lift them immediately.

For more than two decades, people in the United States have taken mifepristone to safely end their pregnancies. But despite a thoroughly documented history of safe use, this medication remains subject to burdensome, medically unnecessary restrictions—including the requirement that it be dispensed in person. For too long, this has created barriers for people seeking access to medication abortion care.

During the coronavirus pandemic, which has disproportionately impacted Black and brown communities across the United States, these restrictions have put people seeking reproductive health care and medical providers in harm’s way. Under these restrictions, someone seeking an abortion would be forced to go into a doctor’s office, risking coronavirus exposure. They would also need to potentially take off work, seek childcare, and travel to attend their appointment. These restrictions take economic privilege to overcome and further entrench long standing health inequities.

Early in the coronavirus pandemic, the FDA decided to ease in-person dispensing requirements for several medications because of the risk they posed for patients. However, one glaring omission was mifepristone. Of the more than 20,000 drugs the FDA regulates, mifepristone is the only drug the FDA requires patients to obtain in person at a hospital, clinic, or medical office, but does not restrict the ability of patients to self-administer—unsupervised—at home or at a location of their choosing.

According to the American College of Obstetricians and Gynecologists, the leading nonpartisan organization of OB-GYNs in the United States, in-person dispensing requirements for mifepristone “have no medical basis, provide no patient benefit, and unnecessarily restrict access to care.”

Since it was approved in 2000, more than four million people in the United States have used mifepristone. Data shows that fewer than one-tenth of one percent of patients who take mifepristone experience major adverse medical events. Because there is no medical reason to require patients to obtain mifepristone in person, and because drugs with greater risks are exempt from similar requirements, mifepristone’s in-person dispensing requirement is a thinly veiled attempt to stigmatize safe, simple abortion care.

While abortion remains a legal right under the Constitution, it has become a nearly impossible right for some people—mostly poor, marginalized individuals—to exercise.

In Planned Parenthood of Southeastern Pennsylvania v. Casey, the Supreme Court held that the government may restrict abortion access so long as doing so does not place an “undue burden” on the pregnant person. The concept of “undue burden” has left it unclear how many restrictions are too many, and this ruling has allowed those who oppose abortion to weaponize restrictions with the goal of taking us back to pre-Roe times.

As a result, abortion access has been steadily whittled down by anti-choice politicians for decades. And while abortion remains a legal right under the Constitution, it has become a nearly impossible right for some people—mostly poor, marginalized individuals—to exercise.

woman holding sign that reads "protect safe, legal abortion"

Protesters in St. Louis, Missouri, in May 2019.

SAUL LOEBGetty Images

Last summer, following a lawsuit led by ACOG, a federal court in Maryland ordered FDA to suspend the in-person dispensing requirement for mifepristone during the coronavirus pandemic, as it had for other drugs. But the Trump administration asked the Supreme Court to intervene, and last month the Supreme Court granted the administration’s request to reinstate the in-person dispensing requirement for mifepristone.

In a dissenting opinion to this decision, Justices Sonia Sotomayor and Elena Kagan pointed out that maintaining the FDA’s in-person requirements for mifepristone during the coronavirus pandemic “imposes an unnecessary, irrational, and unjustifiable undue burden on women seeking to exercise their right to choose.” The two wrote: “The FDA’s in-person requirements for mifepristone have now been suspended for six months, yet the Government has not identified a single harm experienced by women who have obtained mifepristone by mail or delivery.”

In short: There are no medical reasons for the mifepristone restrictions, only ideological ones. And in light of the danger this requirement poses to people seeking medication abortion care at the height of the coronavirus pandemic, the FDA must immediately lift the unnecessary in-person dispensing requirement. Abortion is health care and should not be further siloed and stigmatized in our policy. We are committed to working with our colleagues to continue to fight to protect and expand access to safe, legal abortion care now and through the future.

Congresswoman Carolyn B. Maloney represents New York’s 12th congressional district in the House of Representatives and chairs the Committee on Oversight and Reform. Congresswoman Ayanna Pressley represents Massachusetts’s 7th congressional district in the House of Representatives, sits on the Committee on Oversight and Reform, and is a Task Force Chair of the Pro-Choice Caucus.

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