When a patient asks Dr. Graham Chelius for an early-term abortion, all he can do is tell them to buy a plane ticket.
Chelius is a family medicine doctor at a hospital on the Hawaiian island of Kaua’i, where there are no surgical abortion providers. His best option is to instead write patients a prescription for what is called a medication abortion: using two drugs – mifepristone and misoprostol – over the course of two or three days, the patient would end their pregnancy themselves. Save for a routine follow-up two weeks later, they wouldn’t need to see Chelius again.
But if he wrote that prescription, his patients wouldn’t be able to fill it. Mifeprex, the American brand name for mifepristone, is one of a handful of drugs that the FDA says is too dangerous for retail pharmacies. It can only be dispensed at pre-approved clinics, hospitals, and private practices, and the hospital where Chelius works doesn’t stock it. The process for approval is so onerous that nowhere on Kaua’i does. And time is an essential factor. Past the ten-week mark of a pregnancy, a patient’s only option is a much more invasive and expensive surgical abortion on another island. “My patients are suffering as a result,” Chelius wrote in an ACLU blog post last year, “so I’m taking the FDA to court.”
His suit, brought by the ACLU, is part of a growing movement within reproductive health to counter ongoing attacks on abortion access, by forcing the FDA to allow pharmacists to dispense Mifeprex. Advocates — among them medical experts and pharmacy associations — argue that such restrictions are outdated, possibly politically motivated and, at the very least, unjustifiable (Canada and Australia have abandoned them). “It doesn’t make sense after 18 years of experience with this medication,” says Dr. Daniel Grossman, an OB-GYN who directs the ANSIRH reproductive health research program at UC-San Francisco. “It’s very safe, and it could dramatically improve access for patients.”
This is not how the medical establishment expected things to turn out when the FDA began clinical trials for mifepristone in the mid-‘90s. Doctors in Europe had been prescribing it since 1988, and doctors stateside were excited by the drug’s possibilities: it had the potential to move some abortions from the public sphere (identifiable, protest-ready clinics) to the private one (a doctor’s office or patient’s home), creating a future for patients seeking abortions free of the conflict that had characterized the procedure’s presence in the U.S. since it was legalized in 1973. “People were expecting that it was going to break down barriers, reduce abortion stigma, reduce harassment and open doors,” says Elizabeth Nash, a policy analyst at the Guttmacher Institute, which researches reproductive health. “But that has not happened.”
Instead, when the FDA finally approved Mifeprex in 2000, it did so under severe restrictions, which are now known as Risk Evaluation and Mitigation Strategies, or REMS. The program sets out extensive, substance-specific protocols for prescribing and taking 74 drugs (out of the nearly 1,800 currently approved by the FDA) that, without serious supervision, can kill or permanently injure patients. Suboxone, an opioid dependency treatment that is itself addictive, has a REMS. So does Accutane, the drug for severe acne, which can cause birth defects and liver failure without proper management. Other substances that are restricted under REMS include medications for psychosis, cancer, and rare blood disorders, as well as medications that can induce a coma and ones that can cause respiratory arrest and internal bleeding. Despite their dangers, most drugs with a REMS are still allowed in retail pharmacies. Fewer than two dozen are not, usually because they sometimes cause immediate side effects requiring medical intervention.
Mifeprex is an outlier in this cohort: it doesn’t treat a severe illness or life-threatening condition, and complications are rare — of the more than three million people who have taken it, only 19 have died, and the non-lethal complication rate is 0.3 percent, lower than many drugs available in pharmacies. Mifeprex also doesn’t require monitoring, and although a two-week follow-up to make sure a pregnancy was terminated successfully is recommended, further visits aren’t mandatory. “It just doesn’t have the safety profile that other drugs with a REMS have,” says Grossman. The restrictions have not made it unpopular, only hard to access. “Thirty percent of abortions are medication abortions,” says Nash, “so it’s become a method that patients are comfortable with, and we know it’s safe and effective.”
Few other REMS drugs are embroiled in political wrangling. Keeping Mifeprex onsite per the REMS requires many layers of approval from advisory boards, lawyers and other administrators. If even one person in that complicated process opposes abortion or just doesn’t want to draw the ire of the anti-abortion movement, approval is unlikely. That’s the issue in Hawaii: Chelius practices in a hospital, and he says the anti-abortion sentiment there is so strong he hasn’t even bothered trying to bring Mifeprex onsite.
“Some of his colleagues object even to the fact that he provides abortion referrals,” says Julia Kaye, the ACLU lawyer arguing the case. Plus, she adds, working on a small island means that “virtually everyone has a family member, friend, or neighbor working at the hospital, and Dr. Chelius is concerned that [following] the REMS would compromise the confidentiality of his patients.”
As the ACLU waits for oral arguments to be scheduled, doctors are pleading their own case with the FDA. In 2016, Mifeprex’s manufacturer and a group of gynecologists asked for a review of whether the REMS was still necessary. In its response, the agency admitted that the drug offers “a substantial therapeutic benefit” to patients, and that complications are “exceedingly rare,” but left the restrictions intact. In response, Grossman and nine other reproductive experts published a call in the New England Journal of Medicine last year to “unburden Mifeprex” from REMS, arguing that the FDA’s findings in the decision defied its own guidelines for the program.
Soon after, Grossman began working to get permission to dispense mifepristone at pharmacies for a study, which he hopes to begin by 2019. Success would make the FDA’s position that much harder to defend. “But as we started doing outreach, [we saw that] pharmacists really don’t have a lot of information about medication abortion, since they haven’t been involved in the service,” Grossman says. “It seemed like there was a need for education.”
So, he and two other researchers published another paper earlier this month in the Journal of the American Pharmacists’ Association, hoping to speak directly to those pharmacists about their potential role in expanding abortion access. But they also spoke to the FDA, pointing out that Australia and Canada have both approved pharmacy dispensing of mifepristone after an initial period of restriction similar to REMS.
Australia made the change in 2016, four years after approving the drug. Canada made the drug available in January 2017 and allowed it in pharmacies less than a year later. Actual dispensing varies by province, so the system is not unlike what might happen in the U.S. — approval at a federal level, with state-by-state implementation. “In countries that have similarly developed health care delivery systems and similar drug regulatory systems, the regulatory process has approved the availability,” Grossman says.
Reached for comment about the paper, the FDA said it does not respond to specific studies; asked about the REMS, the agency replied only that “after taking into consideration the safety data [we] concluded that certain restrictions continue to be necessary to ensure the safe use of the drug.”
There are almost 70,000 pharmacies in the U.S. andfewer than 800 abortion clinics. Local availability of an easy, private abortion option would border on the revolutionary. “We could finally, perhaps, see some of the promise we were expecting in 2000,” Nash says.
This potential hinges on what is perhaps the most notable and unusual element of the REMS on Mifeprex, which is what it doesn’t say: Of the very few drugs whose REMS prohibits pharmacy dispensing, Mifeprex is the only one that does not have to be physically ingested under medical supervision. Some states have passed legislation requiring otherwise, but the FDA doesn’t care where someone swallows the pill, only where they are standing when they get it.
The REMS also doesn’t cover the second part of a medication abortion, misoprostol, which is taken 24 to 48 hours after Mifeprex to induce contractions and complete the process. You can get that drug in a pharmacy just fine, and many people take all the pills at home. “It’s important to recognize that it’s is pretty much identical to a spontaneous miscarriage,” Grossman says. By allowing patients to walk away with the medication, the FDA is tacitly stating Mifeprex is perfectly safe, even as they deny it in their official statements.
“Way down the line, it’s not unrealistic to think of these medications being available over-the-counter,” says Grossman. After all, people in the U.S. who either can’t afford or lack access to clinic-supervised abortions are already managing their own at home, often with mifepristone purchased illegally from online retailers. “I don’t think it will happen very soon” he says. “But I don’t think it’s at all out of the realm of possibility.”