For most pregnant people seeking safe and effective abortion pills, the U.S. Food and Drug Administration (FDA) has created a Byzantine set of rules that delay or block access to care. This is true even in the best of times.
Now, in the midst of a public health emergency, these requirements are further endangering patients and straining the health system. Under federal law, the FDA can impose Risk Evaluation and Mitigation Strategies (REMS) on drugs that it believes could do more harm than good if not carefully controlled. FDA scientists and outside advisory experts weigh a variety of factors including the seriousness of the disease or condition to be treated, the size of the population expected to use the drug, the duration of treatment, and the seriousness of potential side effects, such as liver damage. When a drug can truly help people but also carries real dangers, REMS helps ensure that benefits outweigh risks.
But sometimes, a medication’s biggest risks aren’t health-related at all, they’re political. In those cases, FDA scientists and medical experts can find themselves over-ridden by political appointees. Not surprisingly, medications for women’s reproductive health are particularly vulnerable to sacrifice for political expediency. So although REMS are supposed to protect patients, the REMS imposed on abortion pills serve mainly to protect political agendas.
How can we be so sure? By examining the evidence.
First and foremost, the safety data are clear. Medication-induced abortion is significantly safer than carrying a pregnancy to full term. And mifepristone — one of two medications taken in tandem to induce an abortion — has a better safety record than many commonly used drugs, including Viagra and Tylenol. Yet, mifepristone has a strict REMS, putting this very safe drug in the same category as very dangerous drugs like thalidomide and fentanyl.
Misoprostol, the second drug in the regimen, was approved for treating gastric ulcers in 1988 before its role in abortion was known; it has long been widely available in the U.S. like other commonly used prescription drugs. However, until 2016, its use in the context of an abortion with mifepristone was also highly regulated. And, while misoprostol alone can be used to induce abortion, it’s far more effective when both medications are taken within a day of each other.
By making mifepristone so hard to access, the FDA is putting people with unwanted pregnancies at more risk, not less. Dive a little deeper and the full disconnect becomes even clearer.
As part of mifepristone’s REMS, the FDA mandates that 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 go 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. 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 stocking it on their own.
Another restriction requires providers to obtain a signed Patient Agreement Form from each patient before dispensing the pill. While the agreement form may be the least burdensome component of the REMS, it’s notable for another reason: 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 the form be removed (and, hence, the requirement for it to be signed), only to be overruled by the FDA commissioner himself. In 2016, 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 [CDER] was considering, the [c]ommissioner... 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, is a shocking break from the norm and almost certainly represents the tip of the iceberg of political interference.
But just as important as what the mifepristone REMS require, is what they don’t.
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 align its label 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, the FDA previously required patients to take both mifepristone and misoprostol in a provider’s office. 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.
Likewise, the FDA previously required patients to undergo a physical exam both before and after taking the pills. Now, providers can consult with patients remotely in most cases. 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.
In short, FDA rules now permit patients to meet with their doctors by phone or video call, take both medications at home, have their abortions at home, and 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 transit, sometimes in someone else’s car, sometimes hundreds of miles from home — just to pick up pills from a registered facility only to turn around and take the pills and have the abortion at home.
But that’s not all.
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 “the rate of adverse events with Mifeprex is much lower” than with Korlym. And yet the FDA places far fewer restrictions on Korlym than on the same drug at a lower dose used once that it admits is safer.
And finally, the last evidence is the FDA’s March guidance suspending enforcement of other REMS requirements during the COVID-19 outbreak — even for drugs with a far riskier safety profile. Writing in The Hill this April, NWHN Executive Director Cynthia A. Pearson and former FDA assistant commissioner for Women’s Health (and former NWHN board member) Susan F. Wood were direct:
The FDA has a clear legal authority to end these restrictions on medication abortion. In fact, the FDA has already relaxed REMS restrictions on other, more dangerous, drugs such as Turalio and clozapine. The FDA took that step on March 22. And yet, the FDA has let over four weeks go by without taking any action on medication abortion.”
Pearson and Wood also noted that the United Kingdom moved swiftly during the pandemic to issue new guidance authorizing physicians to conduct telehealth appointments and mail abortion pills to protect both patients and clinicians.
In summary, the FDA imposes a burdensome travel requirement on patients seeking FDA-approved abortion pills, although every other part of the process can occur at home. That requirement provides no medical benefit and makes no sense. The FDA permits the same two drugs (mifepristone and misoprostol) to be distributed through the mail with no travel requirement when used for non-abortion purposes, even when taken at higher doses or used daily and even though abortion is safer than pregnancy. The FDA publicly acknowledges that, on at least one occasion, the commissioner himself overruled the recommendations of the agency’s scientists to maintain part of the abortion REMS. The FDA has suspended REMS requirements on other, more dangerous drugs.
The problem is political, and the solution must be too. That’s why the NWHN has launched our #MailTheAbortionPill campaign to raise public awareness, pressure the FDA, and counteract the opponents of women’s health who’ve used their ties to the Trump-Pence administration to attack our reproductive health at every turn.
We can’t afford to sit quietly and hope that anti-abortion extremists won’t push the FDA to unwind the progress we’ve made thus far. We must act now, and boldly, or the current ‘compromise’ position will shift rightward. Donald Trump has repeatedly demonstrated his willingness to sacrifice public health to bolster his reelection campaign — from promoting snake oil cures for COVID-19 to suing for elimination of the Affordable Care Act in the midst of a pandemic. Only a steady stream of pressure will protect our gains and set the stage for future progress.
As part of our campaign, the NWHN has led a diverse coalition of more than 80 organizations to urge the FDA to lift the REMS and make mifepristone available through the mail and local pharmacies. We have collected thousands of signatures, pushed Trump’s FDA commissioner to meet with us, provided technical assistance to congressional efforts, published an op-ed, created our first-ever animated advocacy video, and even used billboard advertising (donated by a supporter) to help spread the word. You can view all of our campaign resources, share our video, and sign the petition at: tinyurl.com/MailtheAbortionPill.
The FDA’s duty is to protect people, not politicians. The first step in doing so is to allow pregnant people to get the abortion pill where they take the pill — at home.
Sarah Christopherson is the NWHN Policy Advocacy Director.