Abortion Pill Restrictions Won't Be Lifted During Pandemic, FDA Says

Abortion pills have to be picked up in person at a clinic. Experts say that has to change during the coronavirus pandemic.

Mar 19 2020, 1:00pmSnap

When Donald Trump used “two very big words” to declare a national emergency over the novel coronavirus on Friday, he bragged about giving his top health official the “ability to waive laws to enable telehealth” during the pandemic. But it appears that the president’s latitude will not apply to medication abortion care, a federal agency confirmed to VICE.

People who want to end their pregnancies will have to navigate the same restrictions as always, which will become all the more complicated in a pandemic environment.

While telemedicine abortion specifically enables providers to prescribe abortion pills from a distance, longstanding federal regulations require that clinics dispense mifepristone, one of the two drugs commonly used together in medication abortions, in person—meaning the drugs can't be picked up at a pharmacy or sent in the mail. An abortion patient can choose to take their medication at home, but they can’t get it without leaving their home. These federal rules prevent people from staying home and flattening the pandemic curve, an action that saves lives.

Reproductive health researchers who spoke with VICE urged states and the federal government to lift the restrictions on medication abortion as COVID-19 spreads across the U.S. They expressed concern about the literal lengths that pregnant people often travel to to obtain abortions, thanks to the GOP’s draconian state laws and Trump’s federal regulations that have led to clinic closure after clinic closure. The farther abortion patients have to travel, the higher their risk of coming into close contact with people who have the virus or even spreading the virus themselves.

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“Abortion is obviously a time-sensitive medical procedure. It’s not an elective procedure that can just be rescheduled a month or two later,” said Daniel Grossman, an OB/GYN, abortion provider, and director of the University of California, San Francisco’s Advancing New Standards in Reproductive Health (ANSIRH).

Medication abortion is especially time-sensitive: The U.S. Food and Drug Administration (FDA) approves the use of mifepristone for up to 10 weeks’ gestation, though some providers administer it in the second trimester.

“It really just doesn’t make sense to continue to restrict medication abortion."

“We have a solution to this problem, and that solution would be telemedicine provision of medication abortion. It really just doesn’t make sense to continue to restrict this practice, which has been shown in research to be very safe, highly effective, and well-liked by patients.”

Medication abortion is very simple, and highly regulated

Telehealth and telemedicine abortion take various forms. Clinics that practice telehealth may text their patients with instructions before their abortion, whatever type it may be, and with follow-ups after. Under a telemedicine model, medication abortion patients may video conference with perhaps the only provider able to serve multiple clinics across several states.

From a medical standpoint, a provider doesn’t need to be in the same room to prescribe mifepristone and misoprostol, the drug combination proven to be safe and effective for early medication abortions. But FDA regulations most often force that video conference to occur in a clinic and never in a patient’s own home, car, or any other space where they may feel safer and have more privacy.

“Mifepristone must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices, and hospitals by or under the supervision of a certified prescriber,” according to the FDA’s Risk Evaluation and Mitigation Strategy (REMS), a set of requirements supposedly meant “to ensure that the benefits of a drug or biological product outweigh its risks.” The REMS were first put into place for the brand-name Mifeprex in 2011, under the Obama administration, but the drug has had similar restrictions since its approval in 2000.

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Even this limited version of telemedicine abortion is not accessible for all people in U.S.: state-level interference presents another problem. “[Eighteen] states require the clinician providing a medication abortion to be physically present during the procedure, thereby prohibiting the use of telemedicine to prescribe medication for abortion remotely,” according to a Guttmacher Institute policy update from March. Planned Parenthood of the Heartland spearheaded telemedicine abortion in Iowa and defeated a 2015 constitutional challenge by state lawmakers. Alaska, Maine, and Minnesota are among the only other states to offer telemedicine abortion.

“I don’t know if there’s anything the administration could do specifically about the state-level telemedicine [abortion] bans, but at the very least, it could certainly encourage the repeal of those bans, given this state of emergency,” Grossman said.

The FDA won't lift the restrictions during the pandemic

But the FDA remains firm on its regulations, even during a public health emergency. “Certain restrictions, known as a risk evaluation and mitigation strategy (REMS), are necessary for mifepristone when used for medical termination of early pregnancy in order to ensure that the benefits of the drug outweigh its risks,” its Office of Media Affairs told VICE in an unsigned statement that didn't acknowledge the pandemic. The agency did not respond to a follow-up question about why it believes the regulations are appropriate for mifepristone, referring back to its website.

The American College of Obstetricians and Gynecologists’ position statement on improving access to mifepristone describes the FDA’s regulations as medically unnecessary and calls them “outdated” and “inappropriately unique” obstacles to “safe, effective medication.”

Trump’s federal agencies have a record of taking unorthodox and often illegal regulatory actions on a wide range of issues, including health care, and a divided Congress can’t stop them. The FDA falls under the jurisdiction of a highly politicized parent agency, the U.S. Department of Health and Human Services (HHS). Over the past three years, Trump health appointees have rushed through regulations limiting access to abortion and contraception and exposing queer and trans patients to discrimination, whether they’re seeking gender-affirming care or treatment for the common cold—let alone fighting the coronavirus.

During the COVID-19 pandemic, HHS Secretary Alex Azar could perhaps apply Trump’s telehealth mandate to medication abortion by directing the FDA to eliminate or relax its regulations, and allow pregnant people to consult with their providers virtually and obtain mifepristone via their pharmacy or in the mail. HHS’ press office didn’t respond to VICE's requests for comment about encouraging the FDA to take action on mifepristone.

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It’s unclear if the federal government would respond differently under the leadership of a President Bernie Sanders or Joe Biden. The campaigns for the Democratic candidates did not respond to VICE's requests for comment. (The Obama administration in 2016 relaxed but did not remove the mifepristone regulations.)

The abortion pill restrictions make even less sense now

Gynuity Health Projects is demonstrating what an evidence-based reality could look like on a smaller scale. Under FDA approval dating back to the Obama administration, the research organization’s direct-to-patient TeleAbortion study opens up telemedicine abortion to qualifying participants who live in one of 11 partner states—meaning Gynuity is allowed to send abortion pills through the mail. Grossman pointed to that model as a solution amid the pandemic. “That is what we need right now,” he said.

Exemplifying the opposite of what's needed right now is the situation in Texas, a red state where COVID-19 could calcify the layers of bans and barriers that already place abortion out of reach for many pregnant people.

The state requires mandatory counseling, ultrasounds, and waiting periods, necessitating multiple clinic visits, and telemedicine abortion is prohibited. ”Those policies that require two visits, that require you to come and expose yourself potentially to coronavirus in a group setting twice, don’t make a lot of sense right now,” said Abigail Aiken, a public policy professor at the University of Texas, Austin.

"Policies that require two visits—that require you to come and expose yourself potentially to coronavirus in a group setting twice—don’t make a lot of sense right now."

Aiken urged the state to loosen its grip on its mandates and bans for the sake of patients and providers alike. “I know that clinics right now are doing [their best]. Obviously, they are sanitizing, they are disinfecting, they are trying to make sure that the care they provide for their patients is as safe with respect to the coronavirus risk as possible,” she said. “But I think that’s a lot of pressure to put on clinics when there are other ways we could make this safer for people, and essentially the law is what is stopping [us] from doing that.”

A few telemedicine sites already exist to send abortion pills to people in the mail, but they operate outside the FDA's rules. Aiken was the lead researcher on a 2019 study in the American Journal of Public Health that examined abortion demand through Women on Web, an online global telemedicine service for self-managed abortion, which occurs outside of a medical setting. Women on Web had fielded thousands of requests from U.S.-based pregnant people who sought mifepristone and misoprostol to perform their own medication abortions. People have been self-managing their abortions in a variety of ways for millennia, but “a rapid increase in legislation restricting access to abortion in the clinic setting” has contributed to renewed interest in self-managed abortions, the researchers concluded.

Soon after Women on Web founder Rebecca Gomperts launched the companion site Aid Access to serve the United States, the FDA vowed to investigate it. Aid Access and the FDA remain embroiled in court as the Amsterdam-based physician’s group continues to serve pregnant people in the U.S., pandemic or no pandemic. But she recognizes how much the situation could improve if the FDA changed its regulations on mifepristone.

“One of the problems, of course, with Aid Access is the time that people have to wait for the packages," Gomperts told VICE, of the medications that are shipped from an Indian pharmacy. "It would be so much nicer if there would be the possibility to do this within the countries.”

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“Telemedicine is the solution—period—to this.”

The Trump administration could provide that solution, if only its top officials recognized that abortion is health care.

If the FDA allowed mifepristone to be dispensed at pharmacies or by mail, abortion pills would likely become much cheaper and more accessible than they currently are in clinic settings. Aid Access charges $90, while a medication abortion in a clinic costs an average of $535 but “can cost up to around $1000,” according to Planned Parenthood. And as people get laid off or have to stay home from work without pay, cost will become even more of a barrier.

As people get laid off or have to stay home from work without pay, cost will become even more of a barrier.

“The public health measures being put into place in response to the COVID-19 crisis are particularly challenging for people living on low incomes, who may not be paid when they don’t work, and may have limited options for childcare when their kids are out of school,” Grossman said. Women who seek abortion must often contend with childcare; the majority are already parents, according to Guttmacher data.

Grossman noted another stressor: “The majority of women seeking abortion are living below 200 percent of the federal poverty level, so the added financial pressure of the coronavirus pandemic may be particularly hard for them.”

The Trump administration likely won't act

Rather than lift the restrictions on medication abortion, House Republicans and the White House nearly derailed the coronavirus relief package over a fight to include the anti-abortion Hyde Amendment that prohibits federal health insurance plans from covering abortion and disproportionately affects pregnant people with low incomes and people of color.

The majority of congressional Democrats now support legislation to permanently end the Hyde Amendment, thanks to the work of Black women- and women of color-led reproductive justice groups, and Sanders’ and Rep. Pramila Jayapal’s Medicare for All bills would proactively end Hyde, too. Without it, Medicare, Medicaid, and other federal health insurance plans could cover the cost of a mifepristone prescription, though a prescription may not even be necessary. “Mifepristone and misoprostol meet many of the FDA’s criteria for being available over the counter,” according to ANSIRH’s ongoing research into the possibility.

These actions are improbable under the current administration. Trump charged Vice President Mike Pence—who campaigned on “send[ing] Roe v. Wade to the ash heap of history, where it belongs”—with the federal government’s response to coronavirus.

Pence told reporters at a March 10 coronavirus task force press briefing “it was a year ago that Medicaid actually expanded to pay for telemedicine. Medicare pays for telemedicine.” But Medicaid and Medicare can’t pay for abortion, no matter the means or method, due to the Hyde Amendment. Unless the administration suddenly reverses its wholesale opposition to reproductive health, rights, and justice, people who need abortions may have to venture into a pandemic to obtain constitutionally protected care.

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Tagged:

abortion, FDA, Coronavirus, Mifepristone, medication abortion, COVID-19

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