To protect abortion access, the FDA should decline to enforce a mifepristone ban | David S Cohen, Greer Donley and Rachel Rebouché

On Friday, the nation faced dueling decisions from federal judges regarding the first drug in a medication abortion: mifepristone. A judge in Texas ruled that the Food and Drug Administration (FDA) likely improperly approved the drug, putting mifepristone's approval on hold while the case plays out (though this order won't take effect until late Friday this week). Minutes later, a judge in Washington state ruled that the FDA could not change the status quo regarding mifepristone's availability.

In response to these two cases and two other less-publicized cases involving the FDA and medication abortion, the agency needs to chart a course consistent with its mission to protect patient health and to follow the evidence. As the Biden administration has stated, protecting medication abortion is a public health imperative now that states can ban all abortion outright. If the agency does not respond to these conflicting rulings in a manner tailored to provide the greatest access possible to medication abortion, it will be telling of Biden's commitment to reproductive justice.

Though the case in Texas has garnered enormous attention, it is not the only case thrusting the FDA into the center of the abortion debate. The others have the opposite goal of improving access to the drug. The litigation in Washington state, not widely discussed until Friday, centered around the FDA's special and onerous regulation of medication abortion. Eighteen state attorneys general sued the FDA arguing that the agency's overregulation is not justified by the statute or the drug's safety and must be lifted. If successful on appeal, this would ensure mifepristone is treated like other prescription drugs - prescribed through any provider and accessible at any pharmacy.

Plaintiffs in two other cases are pushing even further, trying to use the FDA's special regulation of mifepristone to argue that a state cannot ban or overregulate the drug. These lawsuits, filed respectively by the generic manufacturer of mifepristone in West Virginia and a physician in North Carolina, might restore access to medication abortion across the country. The plaintiffs argue that federal approval of mifepristone trumps state abortion laws, essentially forcing all states to allow medication abortion as regulated by the FDA.

The FDA is caught in the crosshairs. Though the agency prides itself on scientific independence and seeks to avoid the appearance of partisanship, any reaction the agency has to these cases - even a decision not to act - will appear political to one side. Nonetheless, the FDA must push forward to ensure access to this critical drug.

Starting with the two cases just decided, the agency can comply with both by announcing that it will exercise enforcement discretion. Enforcement discretion allows the agency to provide safe harbor for technical violations of law. So even if mifepristone becomes an unapproved drug per the Texas order, the agency could announce that it would not pursue action against the entities that market or dispense the drug to maintain the status quo as required by the Washington case.

This would not require the agency to "ignore" the Texas order, as some have suggested. Rather, enforcement discretion is a normal part of the FDA's operation and only relevant if the drug becomes unapproved as ordered. The FDA could exercise this discretion without being ordered to by the Washington court, but the Washington case provides enormous political cover for the agency to use this discretion.

Repercussions for patient and public health could result from the FDA failing to clearly exercise its enforcement discretion. Clinicians may turn to a different medication abortion regimen that does not include mifepristone and is outside of current FDA regulation. Though alternative regimens will be vital to maintaining abortion access if mifepristone becomes inaccessible, they are slightly less effective and, more importantly, will upend what has been the uniform, established protocol for a medication abortion in the United States for over two decades. Relatedly, confusion is sure to reign after the Texas decision unless the FDA speaks in a clear and timely voice. Already, certain abortion providers have indicated that they will continue to dispense mifepristone regardless of the order in Texas unless the FDA tells them they cannot.

As requested by plaintiffs in the Washington case, the FDA could also start the process to remove the unnecessary barriers to accessing mifepristone, which every relevant medical organization agrees are not medically necessary. These barriers make abortion less accessible without any benefit for patient safety. Though the FDA has repealed parts of these unduly restrictive rules over the last decade, the FDA should abandon the remaining restrictions, which are also contradicted by the best evidence. These policies do not make the agency seem evenhanded; they make it seem unscientific. The agency should not wait for the Washington court to order this - it should start the process now.

In the pre-emption cases, the FDA could help the effort to restore access to early abortion in states with abortion bans by embracing the theory that the federal agency's regulation of medication abortion trumps state law. The Department of Justice has already signaled its agreement, but the FDA has been silent. The FDA has spent decades assessing the risks and benefits of medication abortion, examining and re-examining the evidence even decades after its approval in 2000. States should not be able to override that authority and create a public health crisis by banning a safe and effective medication.

The agency, however, has appeared unwilling to remove the remaining unnecessary barriers to mifepristone or support pre-emption at this juncture. Indeed, it has said nothing about pre-emption and is opposing the attorneys general in the Washington case - a fact that may surprise people who think the Biden administration is doing all it can to support abortion access. Given the current public health crisis, the FDA must be bolder in its support of reproductive healthcare.

Try as it might, the FDA cannot escape the abortion debate. Instead of trying to play both sides, the agency must act now by following the science and protecting the public's health to the best of its ability. Protecting access to safe abortion is the way to do that.