The FDA’s abortion pill update includes pointless and harmful restrictions

Last Tuesday, the Food and Drug Administration formally updated its regulation of medication abortion to allow pharmacies to dispense abortion pills. 

This decision spelled out the details of an announcement it made in December 2021: No longer would people be required to go in person to an abortion clinic or other healthcare facility to obtain medication abortion — the two-drug regimen approved to terminate a pregnancy through 10 weeks. Rather, patients can now also receive abortion pills through the mail or from a pharmacy that has been certified in accordance with FDA requirements. 

Although this announcement has been widely applauded as expanding access to abortion pills, in reality, it continues the FDA’s unusually harsh treatment of medication abortion. Unlike most other drugs, including many that are riskier, the agency will not allow any pharmacy to dispense mifepristone (the first drug taken during a medication abortion). Only a limited pool of pharmacies can do so: those that take affirmative steps to become “certified.” This certification process requires, among other things, that a pharmacy agrees to detailed record keeping, reporting and medication tracking efforts and to designate a representative to ensure compliance. 

Though the requirements could have been more onerous, they are nonetheless administrative burdens not required for most other drugs, and certainly not for drugs with mifepristone’s efficacy and safety record. This extra step will take time and resources, meaning many pharmacies will simply not get past these roadblocks.  

These burdens are compounded by the inherent political risks of dispensing medication for abortion. For instance, a certified pharmacy could face protests and boycotts from the antiabortion movement. Many pharmacies may not see the benefits of certification outweighing the costs. 

And even if some new pharmacies chose to become certified, as Walgreens and CVS announced they would, this decision will not pave the way for easy access to abortion pills. In states where abortion is banned, the decision will have no impact. Pharmacies there could become certified, but other state laws could make it illegal for them to dispense pills. Plus, the state abortion ban will prohibit licensed providers in the state from even prescribing abortion pills in the first place. 

Even in states where abortion remains legal, barriers will remain. This is not an over-the-counter approval and the FDA still only permits certified providers to prescribe abortion pills. This means patients must still find a provider who has jumped through that set of unnecessary hoops imposed by the FDA. These requirements force providers to affirmatively opt-in and complete paperwork attesting to their credentials, which pointlessly limits the pool of potential abortion providers. There is no evidence-based reason for this extra provider certification, but the FDA has kept this in place nonetheless. 

Further, some states have their own requirements on who can be an abortion provider, which imposes even more limits on how pills can be prescribed and dispensed. Some states still require in-person appointments, mandate excessive reporting, or only permit physicians to prescribe. In other words, just because pharmacies can now dispense pills does not mean it will be any easier for patients to obtain a prescription for the pills. 

With all this in mind, there is a key aspect of the decision worth celebrating: The FDA permanently removed the in-person dispensing requirement, a rule that forced patients to pick up pills in person. First announced in December 2021, but not formalized until last Tuesday, this change was significant and important. It allowed virtual clinics to proliferate, mitigating some of the damage associated with the Supreme Court’s decision to revoke the constitutional right to abortion. It also allowed mail-order pharmacies to dispense abortion pills with the FDA’s permission: pharmacies that will certainly become certified and continue operating as usual. Virtual abortion meant that there were more providers offering care in states that allowed it, helping free up brick-and-mortar clinics to care for patients who need in-person treatment.  

But instead of simply removing the in-person dispensing requirement, which would have allowed any licensed pharmacy to dispense the drug by default, the FDA made the affirmative decision to limit which pharmacies could dispense it. There is no reason to celebrate this burdensome rule as a game-changer. 

Praising the FDA’s decision as an unadulterated victory is not only wrong, it is also risky. Antiabortion activists are trying to get mifepristone removed from the market nationwide and force virtual clinics to shut down. A key part of this strategy is a new lawsuit filed before a conservative federal judge in Texas late last year. Overstating the impact of the FDA’s pharmacy certification decision now as a huge win for abortion rights perpetuates the narrative at the heart of this lawsuit that the FDA is promoting, not limiting, abortion access. That simultaneously feeds into the antiabortion movement’s legal argument against pills — that the FDA has regulated them too leniently — while wrongly giving the impression to the American public that they can obtain pills much more easily now than before. 

The truth is that the FDA has always over-regulated abortion pills. And since the Supreme Court revoked the right to abortion, the FDA could do much more to protect post-Roe abortion access. It could state affirmatively that its regulations preempt state abortion bans and remove the unnecessary barriers imposed on providers in order to prescribe pills. But whereas other agencies, like the Department of Health and Human Services, have used their power to promote reproductive healthcare, the FDA has stayed on the sidelines.  

The future of the abortion debate in this country will be a fight over pills. It is time for federal and state powers that can shape that debate to adopt policies that will actually accomplish the goal of making abortion pills more easily accessible for those who need them. 

Greer Donley is a John E. Murray Faculty Scholar and associate professor of law at the University of Pittsburgh Law School. Rachel Rebouché is the dean of Temple University’s Beasley School of Law and James E. Beasley professor of Law. David S. Cohen is a professor of law at the Thomas R. Kline School of Law at Drexel University. (dsc39@drexel.edu.)