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 a 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 population likely to use the drug, the 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, REMS can help 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 treated for any 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 carries a strict REMS, even though it has a better safety record than many commonly used drugs, and even though 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
As part of the REMS for mifepristone, the FDA mandates the following ETASU:
1) 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 up their pills, 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. One study found that "the number of ob-gyns providing medication abortion might at least double if they could write a prescription for mifepristone" for patients to pick up at retail pharmacies instead of having to stock it on their own.
2) 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 and OBGYNs who would otherwise be interested in offering medication abortion, particularly when combined with the pre-purchasing requirements above.
3) Certified Providers 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.
The head of the Center for Drug Evaluation and Research (CDER) — the entity within FDA that traditionally has the final say — was explicit: “After being briefed on the planned changes that [CDER] was considering, the commissioner ... requested that the Patient Agreement Form be retained as an element of the REMS.”
For the commissioner to be involved in the granular details of a REMS, even down to the inclusion of an agreement form, and for the head of CDER to openly acknowledge it, was a shocking break from the norm — and almost certainly represents the tip of the iceberg of political interference.
What the Mifepristone REMS Don't Require
More than four years ago, the agency made a number of positive updates to the rules governing mifepristone use 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.
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.
But that's not all.
When Mifepristone Is Used for Something Other Than Ending a Pregnancy, You Can Get It in the Mail
In addition to inducing abortion, mifepristone is approved for use in treating high blood sugar in adults with Cushing's syndrome under the brand name Korlym. When mifepristone is used to induce an abortion (brand name: Mifeprex), the patient takes a 200 mg dose one time. When mifepristone is taken to treat Cushing's, the patient takes a dose of between 300 mg to 1200 mg every day for months or even years. And yet Korlym is not subjected to REMS and can be mailed directly to a patient's home.
In its 2016 medication review, the FDA acknowledged that “Korlym is taken in higher doses, in a chronic, daily fashion unlike the single 200 mg dose of Mifeprex that is the subject of this supplement; the rate of adverse events with Mifeprex is much lower” (emphasis ours). And yet the FDA places far fewer restrictions on Korlym than on the same drug at a lower dose that it admits is safer.
Clearly, the risk to making mifepristone widely available for abortion has nothing to do with health and everything to do with politics.
It’s Time to #MailTheAbortionPill
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.
That’s why the NWHN has started our #MailTheAbortionPill campaign, to counteract the opponents of women's health who've used their ties to the Trump-Pence administration to attack reproductive health and rights at every turn.
The time for bold action is now. We can't afford to sit back and hope that abortion opponents won't push the FDA to unwind the progress we've made thus far. And we can't afford to compromise with ourselves before even making our ask, or we will end up with the 'middle ground' shifting rightward.
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.
Olivia Snavely is the NWHN Communications Intern.
Sarah Christopherson, MA, is the Legislative Director for the social justice campaign, Americans for Tax Fairness, and the NWHN’s former Policy Advocacy Director. Her 10 years working for Congress and her deep knowledge of health policy and consumer protection make her the NWHN’s issue area expert on federal health reform implementation and defense, drug and device safety and efficacy, and sexual and reproductive health.
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