Biden Could Expand Abortion Access, Even Without the Senate

The path lies not in legislation but through the deregulation of mifepristone—the only drug the FDA has approved to safely and effectively terminate an early pregnancy.

An illustration of Joe Biden and a "Keep abortion legal" sticker
Getty / The Atlantic

Joe Biden is now poised to become the next president of the United States. His victory, however, is bittersweet for many Democrats, especially those for whom abortion rights are a top issue. Democrats lost seats in the House of Representatives, and their odds for a Senate majority seem to be dwindling. Just eight days before the election, Justice Amy Coney Barrett was confirmed to the Supreme Court. Without a Senate majority and with a hostile Supreme Court, some may wonder whether any progress on abortion rights can be made in the next four years.

Abortion-rights advocates need not accept that all is lost. They simply need to look outside legislation and the courts for their answer. First, President Biden can reverse the Trump administration’s rules that limited the contraceptive mandate and forced Planned Parenthood and other organizations to leave Title X’s family-planning program. But beyond restoring the Obama-era status quo, the Biden-led executive branch could pursue an administrative action that would expand reproductive rights further than ever before: His administration could reexamine an FDA policy that places severe restrictions on mifepristone (also known as RU-486)—the only drug the FDA has approved to safely and effectively terminate an early pregnancy (one within its first 10 weeks). Removing this policy would expand access to abortion in most states, even if the central holding from Roe v. Wade is limited or overturned and states are allowed to navigate their own course on abortion.

When the FDA first approved mifepristone 20 years ago, abortion-rights activists were optimistic about the medication’s potential to transform abortion care. In theory, women would be able to obtain a medication-abortion prescription from their regular primary-care physician or ob-gyn, pick up the drug at their local pharmacy, and end their pregnancy in the privacy of their own home. Fewer women would need to travel long distances to an abortion or family-planning clinic, walk past abortion protesters, or undergo a surgical procedure to terminate a pregnancy. This reality, however, has never fully come to fruition. Though the approval of mifepristone has made abortion easier for many women, and the drug now accounts for 39 percent of all abortions, abortion care remains largely isolated to abortion clinics. This means that many women must still travel long distances to essentially pick up a prescription. The primary reason for this is an unnecessary federal policy that can be removed by the executive branch.

When the FDA approved mifepristone to terminate a pregnancy, it imposed stringent dispensing requirements that make the drug difficult to prescribe and obtain. The current iteration of those restrictions (known as a risk-evaluation-and-mitigation strategy, or REMS) is generally interpreted to stipulate that only certified providers prescribe the drug; that women pick up the drug in person from a clinic, doctor’s office, or hospital (not a pharmacy); and that women sign a patient-agreement form, which attests that they received counseling on the risks of the medication.

The fact that health-care providers must not only become certified to prescribe the drug, but also dispense it themselves, imposes logistical barriers that make it impractical for the average provider to offer early abortion care. Most physicians’ offices are not set up to buy and sell prescription drugs to patients—that is the purview of pharmacies. Understandably, providers are not inclined to create this infrastructure, especially for a single drug. So who has taken on the burden of certification and distribution? Abortion providers located in abortion and family-planning clinics. As a result, clinics still provide 95 percent of abortions today, and private physicians’ offices provide only 1 percent, which has kept abortion care segregated from the rest of health care. As the number of clinics has declined across the South and Midwest, many women are forced to travel long distances to access this medication. Five states have only one clinic left. It is well documented that women who must travel long distances to a clinic tend to have later abortions, which are riskier. And the impact of these travel burdens is felt much more harshly by poor women and women of color.

These distribution limitations have no medical benefit. Every major health organization to examine the issue, including the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians, has concluded that the REMS is unnecessary for patient safety. In fact, many riskier drugs, including Viagra—whose fatality rate is six times higher than mifepristone’s—are on the market without any distribution restrictions. Mifepristone is also not subject to any limits on its distribution when it is prescribed to treat Cushing syndrome, even though in those cases it is used chronically, and at higher doses. Furthermore, recent research suggests that medication abortion is safe and effective when prescribed via telemedicine and shipped directly to a woman’s home. This research aligns with common sense, given that the REMS allows women who obtain mifepristone from a clinic to take it at home. Thus, the in-person dispensing requirement does not protect women from any of the drug’s risks; if a woman experiences a complication—rare but certainly possible—it will not occur at the clinic.

Two ongoing lawsuits are challenging the legality of the mifepristone REMS—one related to the pandemic and one attempting to invalidate the REMS whole cloth. In July, the federal district court for Maryland temporarily enjoined the in-person dispensing and signature requirements as unconstitutional during the coronavirus pandemic. But the REMS can be removed much more easily without the courts. The FDA could ask the drug distributor, which sponsored the FDA’s review of the drug, to submit a modification request that would allow the agency to evaluate whether the REMS can be safely released. The sponsor could also submit a request of its own volition to force the FDA to reconsider the REMS. After a scientific review, an objective FDA would almost certainly conclude that the scientific evidence shows that the REMS is unnecessary. A new FDA commissioner, appointed by Biden, could start the process immediately. Though a decision to remove the mifepristone REMS would likely be challenged in the courts, a plaintiff would be hard-pressed to prove that the FDA—a scientific agency—acted improperly by listening to scientists.

The result: a win for reproductive rights that is not dependent on the Supreme Court or Congress. Removing the mifepristone REMS might not expand abortion access everywhere—especially not in the 19 states that have their own limits on the drug’s distribution (or other states that might pass similar statutes). But it would widen access in the remaining 31 states, ensuring, for instance, that medication abortion would be available to women through telemedicine, obviating the need to go to a clinic. Patients would still have to obtain a medication-abortion prescription, but without the REMS, any provider could prescribe it (so long as they follow state abortion laws) and patients could pick it up from their regular pharmacy. The political risks for Biden would be low, given that most Americans support the right to first-trimester abortion and that expanding its accessibility should reduce the need for second-trimester abortions, which are more controversial. This action would also give him an opportunity to reassure the women in his base that he is fighting for their interests, especially in light of the losses many are expecting in the Court with Justice Barrett’s confirmation.