Earlier this month the Food and Drug Administration (FDA) took the noteworthy step of removing a restriction on access to the drug mifepristone: Patients will no longer be required to collect the drug — the first of a two-drug regimen that induces abortion before 10 weeks of pregnancy — at a health care facility. The federal agency’s move appears to give a welcome boost to abortion access, but the FDA could and should have gone further.
When the FDA approved mifepristone in 2000, it dictated how the medication is prescribed and dispensed. The broad consensus among experts is that the FDA restriction on how patients could access the drug was unnecessary — mifepristone has a better safety record than penicillin and Viagra — and unique, given how other drugs of comparable risk are regulated.
The FDA’s restriction was also punitive as applied. There was no compelling medical reason to require patients to travel to a brick-and-mortar clinic to pick up the medication. The restriction imposed significant barriers of time, expense, and travel for early abortion care — costs that have fallen most heavily on low-income women, for whom delay and expense can put abortion out of reach.
With this policy change, providers in the 31 states that permit telehealth for abortion consultations can meet with patients over the phone or online, without special permission from the FDA or as part of a temporary pandemic safety measure. If the patient is a good candidate for a medically induced abortion, providers can prescribe the drug and patients can receive it by mail or through a local certified pharmacy. This change may be a boon to an innovation born of the pandemic — wholly virtual abortion clinics — whose numbers could grow.
The FDA also decided that certified pharmacies can now dispense mifepristone. This means that the cost of stocking the drug shifts from health care practitioners to pharmacies. Previously, health care practitioners had been required to keep it in house or to contract with a mail-order supplier.
The FDA’s decision comes at a critical time: Constitutional protection for abortion hangs in the balance, with the Supreme Court appearing poised to overturn cases establishing abortion rights. And as states like Texas have passed the most severe anti-abortion laws in a generation, the FDA’s loosening of restrictions on mifepristone could spell relief for those seeking abortions in states where access is vanishing.
Unfortunately, the FDA still treats mifepristone exceptionally and upholds some restrictions that have no basis in science. Take pharmacy certification, for example. This is a rare and unnecessary requirement. The FDA has not yet outlined the certification process. Whether it proves simple or cumbersome, the mere prospect of having to opt in might be a barrier for pharmacies wary of harassment and boycotts.
The FDA also kept in place the requirement that only certified providers may prescribe the drug. Under this rule, providers must register with the drug manufacturer, affirming that they can identify and treat mifepristone’s infrequent adverse side effects. The FDA does not require such certification in order to prescribe other drugs, such as penicillin and Viagra, both of which come with greater attendant risks. Certification in and of itself is not necessarily complicated or time consuming; it is, however, an unnecessary administrative step that may reduce the number of providers willing to facilitate early medically induced abortions.
In addition, the FDA’s decision to maintain the supplemental informed consent requirement is unfortunate. Patients are already required to sign an informed consent form. The requirement, then, is redundant, perpetuates the notion of abortion exceptionalism, and stigmatizes the procedure.
Finally, obstacles to more broadly implementing the new mifepristone telehealth policy lie ahead. For one, states that oppose abortion will seek to limit access to abortion medication. This month, a Texas law took effect that bans the use of abortion medication after seven weeks, in spite of the FDA approval of the drug for use during the first 10 weeks. Nineteen states already require in-person pickup of the drug, and those laws will continue to be enforced despite the FDA’s recent decision. Such laws may yet be preempted by the FDA’s new rule, but not without a legal challenge on that ground. As state and federal laws clash in the courts, the fate of access to abortion medication will likely rest in the hands of federal judges.
The federal government took an important step this month to make a safe medicine more accessible. But until abortion medication is treated the same as all other drugs that have low risks but life-changing importance, the FDA’s move isn’t the complete victory for abortion rights that we need.
Rachel Rebouché is the interim dean of Temple University’s Beasley School of Law. Greer Donley is an assistant professor of law at the University of Pittsburgh Law School. David S. Cohen is a professor of law at Drexel University’s Kline School of Law.