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.
Elizabeth Stone: My abortion before Roe v. Wade
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.