This week, the Food and Drug Administration announced that it would allow mifepristone, the first pill taken in the two-drug medication abortion regimen, to be dispensed at retail pharmacies. The FDA’s decision is a welcome move that has garnered headlines, but the fine print contains significant red tape that will continue to serve as a barrier for people already struggling to access medical care.
Because of “abortion exceptionalism” allowing abortion care (and miscarriage management) to be treated differently from other health care, medication abortion has always been more regulated than it should be. When the FDA approved the drug in 2000, it did so under a little-known bureaucratic system known as the Risk Evaluation Mitigation Strategy (REMS). Drugs under REMS usually carry significant side effects or are highly addictive, neither of which is true for mifepristone. Under these restrictions, clinicians who provide medication abortion must register with the FDA and then dispense mifepristone directly to the patient. As two of us wrote last year, this requirement has made it impossible for mifepristone to be available over the counter, or at the very least to be dispensed without unnecessary certifications, despite the fact that it’s safer than Tylenol.
In an effort to reduce the risk of transmission at the onset of the Covid-19 pandemic, the FDA loosened these requirements to allow clinicians to mail the drugs to patients or to use one of two online specialty pharmacies. So the decision this week that health care providers will be allowed to write a normal prescription to be filled at a normal pharmacy is good news.
On one level, the FDA announcement is historic. It codifies the elimination of the requirement for clinicians to dispense mifepristone in person. We have a tremendous amount of evidence that medication abortion can be provided safely and effectively via telehealth without an in-person visit. The FDA took one small step beyond this measure by saying that, in addition to mail-order pharmacies, any retail pharmacy willing to be “certified” may now provide mifepristone as well. That’s progress, since it adds another location where people can obtain the pills after they’ve been prescribed them by a clinician. For some people, such as someone trying to maintain their privacy or who cannot wait for the medications to be mailed, picking up the pills at a nearby pharmacy would be most convenient.
But that’s where our praise of the FDA ends. Despite years of peer-reviewed, evidence-based research, the FDA chose to alter rather than eliminate the REMS for medication abortion. Adding pharmacies to the already cumbersome REMS is unnecessary and further perpetuates the notion that medication abortion is dangerous. To become certified to dispense mifepristone, a pharmacy must commit to doing 14 things that go far beyond what they do for other prescribed medications.
Among other things, the pharmacy will need to keep track of authorization forms signed by clinicians who prescribe mifepristone. Mind you, this is a self-certification process, so it’s essentially a bureaucratic hoop that providers have to jump through that has little meaning. But now pharmacies are required to set up a system to store the signed prescriber agreement forms for any mifepristone prescriptions they fill.
Instead of requiring pharmacies to retain this form, the FDA could have had the prescriber simply write on the prescription that they had signed the agreement form and could send it if needed.
For pharmacies that mail mifepristone to patients, the FDA will require them to track all shipments and document receipt of the medication. If the shipment takes more than four days, the pharmacy will need to contact the prescribing clinician and determine if the patient can still take the medications with the delay. This is a lot of work for the pharmacy, which will add to the cost of the service. Also, while it is possible for pharmacies to know whether the medication was delivered, it will be very difficult to know if the patient actually received it unless they are doing active follow-up by phone, text, or e-mail with the patient.
That pharmacies will be so actively involved in tracking the medication is a little bizarre and out of scale. Depending on the pharmacy, they may or may not be very helpful at resolving the problem. Seen in this context, the FDA requirement that pharmacies actively track these shipments seems like paternalistic busywork.
The long list of requirements for pharmacy certification won’t improve the safety of medication abortion, but it will serve as a barrier to expanding the number of pharmacies that dispense mifepristone. It’s wonderful news that CVS and Walgreens plan to become certified and to dispense mifepristone, but we worry that smaller retail pharmacies may steer clear of certification because of the associated hassle (or pressure from anti-abortion ideologues). If they are the only pharmacy in a rural area, for example, access won’t be expanded.
We applaud game-changing attempts to make abortion more accessible for patients. But the truth is, this isn’t it. It just reinforces the so-called “abortion exceptionalism” that permeates every aspect of health care policy and debate. Now, individual pharmacists and pharmacies get to decide whether abortion will be available to patients.
Nothing in the science suggests the need for the barriers that the FDA insists on keeping in place. This moment is an opportunity for the FDA to reduce or remove the limits associated with medication abortion, but instead it is changing and even increasing them under the guise of expanding abortion access. None of these requirements are in place in Canada, where a large 2022 study documented that medication abortion with mifepristone is provided very safely there.
To fix the mess our nation finds itself in—and actually meet the needs of people who have abortions—we need bold solutions. We need to look to our global friends, like Canada, and follow in their footsteps. We need to follow the decades of data showing that medication abortion safe enough to be made available over the counter for everyone. Until then, we need our communities to speak up and call on their local pharmacies to stock abortion pills so they are available as soon as they are needed. This is a moment for public pressure and demand. If we want abortion access for all, we’re going to have to fight for it. In turn, we need the FDA to stop offering us crumbs and bureaucratic barriers. Follow the science and make medication abortion available for real this time.