The American Civil Liberties Union is suing the U.S. Food and Drug Administration (FDA) over its refusal to loosen outdated restrictions on medication abortion during the COVID-19 pandemic. But some advocates are pushing a workaround, arguing that the FDA rules don’t actually prevent providers from sending abortion pills through the mail.
It’s not the only way the pandemic has prodded doctors to ease the process for telemedicine abortion, eliminating some of the in-person visits usually required even for patients trying to access care remotely. Doctors are finding innovative ways to provide medication abortion without subjecting patients to unnecessary visits to a medical facility, said Elisa Wells, co-founder and co-director of Plan C, an organization that advocates for self-managed abortion care and medication abortion pill access.
The safest way for people to access early abortion care during a pandemic—at home, under remote medical supervision—has been hampered by onerous FDA restrictions since medication abortion was first approved in 2000. One of the pills, mifepristone, is under a set of FDA restrictions called a Risk Evaluation and Mitigation Strategy (REMS) that require it be dispensed by a specially certified medical provider in clinics, medical offices, or hospitals—not pharmacies.
That means that even people who manage to see an abortion provider over telemedicine will likely have to go to a clinic to receive mifepristone in person—unless their provider is part of an FDA-approved research study—even though medication abortion is safe and common. Experts argue there’s no medical reason for this, and have urged the FDA to lift the regulations and allow patients to access mifepristone like any other medication.
“Of the more than 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must receive in person at a hospital, clinic, or medical office, yet may self-administer, unsupervised, at a location of their choosing,” says the lawsuit, which the ACLU filed last Wednesday on behalf of a coalition of medical experts, including the American College of Obstetricians and Gynecologists (ACOG).
“When used for purposes other than pregnancy termination, the FDA permits mifepristone to be mailed directly to the patient’s home in higher doses and quantities,” the lawsuit notes.
According to the legal complaint, the FDA restrictions require patients to pick up mifepristone in person. A growing group of advocates and providers, however, believe the FDA regulation has been interpreted more restrictively by doctors than it needs to be.
The REMS “specifies that mifepristone be dispensed to patients only in clinics, offices, or hospitals by the provider, but nobody exactly knows what that means,” said Elizabeth Raymond, senior medical associate at Gynuity Health Projects. “If the certified prescriber is in the clinic, office, or hospital mailing the pills to the patient, does that count? Some people think it does.”
One of those people is Wells, whose organization, Plan C, has been urging providers to mail mifepristone for months. In April, as the COVID-19 pandemic took hold in the United States, it stepped up the efforts.
“Dispensing is the act of preparing a drug for distribution to the patient (identifying the correct medication, dosage, labelling, instructions, etc). There is no language in the REMS that says you can’t mail the pills, though providers have largely interpreted the REMS to prohibit mailing,” Wells said in an email.
“More providers are stepping up to actually mail the pills,” Wells said. “And that’s what we’ve been working a lot on, is talking to providers and asking them: Now that we have these new test protocols, and it’s clearly the new standard of care, won’t you just do the next step of mailing the pills as a harm reduction approach? It’s the safest and most convenient for everyone.”
The demand is there
As the pandemic increases demand for all kinds of telemedicine services in the United States, and Republican governors throughout the country use the pandemic to push for more abortion restrictions, access to telemedicine abortion has become particularly urgent.
The reproductive health-care provider carafem has seen a spike in inquiries about medication abortion since early March, when states began issuing COVID-19 lockdown orders, said Melissa Grant, carafem’s chief operating officer.
“We went from serving a couple [medication abortion] clients a week to serving between 30 and 40 clients a week,” Grant told Rewire.News.
Carafem, which operates health centers in four states, is part of the TelAbortion project, a research study evaluating the use of telemedicine for providing medication abortion. The TelAbortion study started in 2016 and serves 13 states—Colorado, Georgia, Hawaii, Illinois, Iowa, Maine, Maryland, Minnesota, Montana, New Mexico, New York, Oregon, and Washington.
Providers participating in the TelAbortion study are explicitly allowed by the FDA to mail mifepristone to patients; one of the goals of the study is to gather data on the effectiveness and safety of mailing mifepristone.
In April and May, TelAbortion has served more than twice as many patients as in January and February, said Elizabeth Raymond, senior medical associate at Gynuity Health Projects, which sponsors and runs the TelAbortion program.
“We’ve had a tremendous increase in TelAbortion during the pandemic,” Raymond told Rewire.News. “The limitations people have in getting medical care in person are really leading them to utilize this type of service more.”
A new protocol eliminates unnecessary testing
Meanwhile, the pandemic’s impact on abortion access has ushered in a new medical protocol for medication abortion that experts say is just as safe.
Before the pandemic, the medical community’s standard of care meant patients first had to undergo a blood test and an ultrasound or pelvic exam so that the provider could determine the duration of the pregnancy. Even patients using telemedicine had to first visit a nearby clinic for the physical tests—an expectation that had nothing to do with the FDA’s REMS requirements.
Many carafem patients get an ultrasound or pelvic exam wherever was most convenient for them and not necessarily from the abortion provider, but COVID-19 has made this much more difficult for patients. For some, it’s impossible.
“It was much more challenging for many of our clients not only to come into the health center but even to obtain an ultrasound,” Grant said. Carafem has typically allowed some patients, on a case-by-case basis, to forgo the in-person tests if necessary to protect health and wellbeing. Since March, they’ve expanded that option.
“Evaluation with ultrasound before medical abortion has (up to now) been the accepted standard of care among providers,” Raymond said. “Professional organizations have given mixed guidance [but] nearly all providers have been doing ultrasounds. … Almost no providers until recently have provided [medication abortion] with neither test.”
The pandemic changed that, as more providers recognize the challenges to obtaining an ultrasound, and the lack of medical rationale for it. “Since COVID, all U.S. abortion guidelines organizations have explicitly stated that ultrasound is not needed, and most have endorsed no ultrasound or pelvic exam,” Raymond said. “We don’t know yet the extent to which providers are taking this up.”
Gynuity recently lead a collaborative effort to develop a “no-test protocol” for medication abortion, citing research from 2015 to 2016 that reviewed 406 medication abortions provided in the United States, Mexico, and Moldova without ultrasounds or pelvic exams. The participants reported no serious adverse events that resulted from the elimination of these screening tests.
“This is a huge innovation, an acknowledgment within the medical community that an ultrasound is not needed,” Wells said. “Many doctors have known this, but it’s really hard to change the standard of care in our litigious society. The pandemic has really laid bare the fiction that physical clinics are needed to safely and effectively provide abortion care.”
While these innovations in telemedicine abortion are expanding abortion access during the pandemic, more needs to be done to ensure access in a post-COVID-19 society, advocates said. Currently, 18 states prohibit the use of telemedicine for medication abortion, and Republicans in the U.S. Senate introduced a bill this year to ban telemedicine abortion on the federal level.
“I think this happens in crisis situations, that innovations arise that maybe otherwise would have taken years,” Raymond said. “But there’s a lot of forces working against this too. So we have to pull a silver lining out of this COVID [pandemic] … really try to get as much out of it as we can, so we can counter those forces that are going to be operating after the epidemic is resolved.”