By Sarah Christopherson and Olivia Snavely, National Women’s Health Network
Under federal law, the U.S. Food and Drug Administration (FDA) can impose Risk Evaluation and Mitigation Strategies (REMS) on drugs that it believes could do more harm than good if not carefully controlled. While all medications pose some health risks, some are more dangerous than others, so the FDA balances the benefits of taking the drug with the problems posed by its side effects.
Under normal circumstances, agency scientists consider a variety of factors such as the seriousness of the disease or condition to be treated, the size of the population expected to use the drug, expected duration of treatment, and the seriousness of adverse events, such as liver damage. When a drug can truly help people but also carries real dangers, establishing a risk mitigation strategy (REMS) helps ensure that the benefits outweigh the risks.
For example, olanzapine, an injection drug used to treat schizophrenia, can cause sedation and delirium in the period following injection. Because this poses a serious safety risk (for example, if a patient drives post-injection), the FDA imposed a risk mitigation strategy on olanzapine’s manufacturer with specific Elements to Assure Safe Use (ETASU). Those elements of safe use include mandating that the injection occur at certified health clinics where patients can be observed and, if necessary, treated for adverse reactions. And while many drugs have a “black box” (aka, “boxed”) warning to alert prescribers to side effects or limitations, REMS and particularly ETASU restrictions are supposed to be reserved for only the most dangerous drugs.
But sometimes, a medication’s biggest risks aren’t health related at all, they’re political. Not surprisingly, medications for women’s reproductive health are particularly vulnerable to sacrifice for political expediency. So while the REMS are intended to protect patients, the REMS imposed on abortion pills serve mainly to protect political agendas.
How can we be so sure? First, the safety data are clear. Mifepristone — the first of two FDA-approved medications taken in tandem to induce an abortion — currently has a strict REMS, even though it has a better safety record than many commonly used drugs. But what’s more, mifepristone-induced abortion is significantly safer than carrying a pregnancy to full term.
By restricting mifepristone, the FDA is putting pregnant people at more risk, not less. On that basis alone, the mifepristone REMS make no medical sense. But dive a little deeper and the full disconnect becomes clear.
What the Mifepristone REMS Require — and What They Don’t
As part of the REMS for mifepristone, the FDA mandates the following ETASU:
- The pill must be dispensed in a clinic, medical office, or hospital under the supervision of a certified provider.
As a result, mifepristone isn’t available at retail pharmacies in the U.S. and most patients must travel to a registered clinic to pick it up, even when that means traveling far from home. This requirement also forces providers who want to offer mifepristone to serve as their own mini pharmacy, pre-purchasing the pills and keeping them in stock in their office or clinic.
- Providers must become certified by completing a Prescriber Agreement. This restriction means extra hoops for providers to jump through (for example, they must provide a hard copy of their U.S. DEA license and state medical license) and creates the potential for harassment by having to register as an abortion provider. The extra red tape does little to ensure patient safety, but it burdens family physicians who would otherwise be interested in offering medication abortion, particularly when combined with the pre-purchasing requirements above.
- Certified prescribers must obtain a signed Patient Agreement Form from each patient before dispensing the pill. While this may be the least burdensome component, it’s notable that the FDA’s scientific review process in 2016 concluded that the form was “generally duplicative … of information and counseling provided to patients under standard informed consent practices for medical care” and recommended that form be removed, only to be overruled by the FDA commissioner himself.
But just as important as considering what the mifepristone REMS require is considering what they don’t.
More than four years ago, the agency made a number of positive updates to the mifepristone REMS after doctors and health advocates, including the NWHN, pushed hard to bring the label in line with best practices. Among other changes, the update removed several requirements that had previously forced patients to make multiple trips to a provider’s office.
For example, before March 2016, the FDA explicitly required patients to take both mifepristone and misoprostol — the second medication in the regimen — in a provider’s office. That language was dropped from the 2016 update. Now, patients are permitted to pick up their pills and wait until they get back home again before taking them, unless state law requires otherwise. No matter where the pills are taken, the abortion itself always occurs outside of the provider’s office, sometimes up to 24 hours after taking misoprostol, the second medication.
Meanwhile, ending a pregnancy with mifepristone is 14 times safer than carrying a pregnancy to full term
Likewise, pre-March 2016, the FDA required patients to undergo physical exams before taking mifepristone and again 14 days later to confirm that the pregnancy was successfully terminated. Now, providers are no longer required to do physical exams and are permitted to use medical history instead. For example, as part of its COVID-19 response, the American College of Obstetricians and Gynecologists recommends:
“For medication abortion, clinicians can perform an assessment, counseling, and consent by video or telephone. Patients can safely self-administer both medications (mifepristone and misoprostol) at home. Follow-up after an uncomplicated medication abortion can be provided effectively by video or telephone to review signs of successful pregnancy expulsion; the patient can take a urine pregnancy test at home 4 weeks after the abortion. An in-person visit is not required after an uncomplicated medication abortion.”
All of which taken together means:
The FDA has created a situation where patients can meet with their doctors by phone or video call, can take the pills at home, can have their abortions at home, and can follow up with their doctors by phone or video call after their abortion is over. But first, they must find safe transportation and travel in the midst of a global pandemic — sometimes by public transportation, sometimes in someone else’s car, sometimes hundreds of miles from her home — just to pick up pills from a registered facility only to turn around and take the pills and have the abortion at home.
Contrast these requirements with those of olanzapine, the example from above. Unlike olanzapine, there is no observation period for mifepristone use, no in-person examination, and no information that cannot be communicated via a telehealth appointment. What is the medical benefit to making patients travel to pick up pills that could be available in their neighborhood retail pharmacy or delivered by mail when every other part of the process can occur at home? There is none.
It’s Time to #MailTheAbortionPill
But while there’s no medical benefit to the travel requirement, there are big health risks, particularly during a pandemic like COVID-19, when both pregnant people and clinic staff face exposure to the virus. So why has the FDA maintained the travel requirement during the pandemic, even as it has relaxed the rules for other REMS drugs?
The same reason it imposed the restrictions in the first place: fear of anti-abortion politicians and their far-right supporters. Read more about the history of mifepristone’s approval and fear of anti-abortion violence HERE.
That’s why the NWHN has started our #MailTheAbortionPill campaign, to call on the FDA to lift the REMS and permit pregnant people to receive mifepristone at their homes or local pharmacies.
The FDA is afraid. But their duty is to protect people, not political agendas. The first step is allowing pregnant people to get the abortion pill where they take the pill — at home.