Health

The FDA Is Restricting Access to the Easiest, Safest Form of Abortion

There's a growing consensus that the FDA's regulations on abortion pills aren't medically necessary.

by Marie Solis
Sep 4 2019, 10:00am

Illustration by Cathryn Virginia

In March, a licensed physician and abortion provider in Amsterdam received a cease and desist letter from the United States government.

The Food and Drug Administration claimed Rebecca Gomperts was violating federal law for operating Aidaccess.org: Through the site, Gomperts prescribes the abortion medications mifepristone and misoprostol to U.S. residents who receive the pills by mail, which allows them to end their pregnancies at home. In doing so, the FDA said, Gomperts poses “an inherent risk to consumers who purchase those products.” The agency also accused Gomperts of flouting the decades-long FDA restrictions on mifepristone, which require healthcare providers to administer the drug in person, at a clinic or hospital, making it illegal to sell the drug online or in pharmacies.

“It’s very intimidating to get such a letter,” Gomperts told VICE. “But for me, it wasn’t threatening enough.”

Gomperts launched Aid Access in March 2018 because she saw “a need.” More American women were requesting pills from Women on Web—the international abortion pill site she launched in 2006—and so she thought it made sense to establish a sister site that served the U.S. And as threats to Roe v. Wade steadily mounted, it became clear to Gomperts that the state of abortion access in the U.S. was dire.

Roughly 21,000 women requested abortion medication during Aid Access’s first year, according to University of Texas assistant professor Abigail Aiken, and somewhere between a third and a half of those requests resulted in Gomperts writing prescriptions for pills. The vast majority of the inquiries came from people living in states that have heavily restricted abortion access, like Alabama, Georgia, and Mississippi. But even those who live in states less hostile to abortion might feel the need to seek out Gomperts’ services: As of 2014, 90 percent of counties had no abortion clinic, and 39 percent of women of reproductive age lived in one of those counties. For an increasing number of people, Aid Access represents one of extremely few options for accessing an abortion early in pregnancy.

After consulting a lawyer about the FDA’s notice, Gomperts decided to continue running Aid Access: Knowing so many people rely on her services, she couldn’t imagine shuttering the site. Besides—the way Gomperts sees it, she’s not breaking any rules.

"I sincerely believe there is a human right here to be defended,” she said. “What I’m doing is in accordance with all the human rights agreements that exist, as well as the U.S. Constitution.”

Gomperts isn’t alone in her war with the FDA. Following a barrage of abortion ban legislation, doctors and reproductive health advocates have been escalating calls for the agency to lift the nearly 20-year-old restrictions on mifepristone that make services like Gomperts’ illegal. They say it would significantly expand access to abortion, and more accurately reflect the growing body of research that shows mifepristone and misoprostol are overwhelmingly safe and effective, even when administered outside of a traditional clinic setting.

In a future where an overturned or significantly weakened Roe v. Wade allows states to ban abortion, it's conceivable that most abortions that take place outside of the medical system will involve buying pills online. But as Aiken’s data shows, it’s also how an increasing number of people are accessing abortion in our fearful present: Even with Roe in effect, decades of anti-choice lawmaking have made the right to an abortion little more than a concept for millions of Americans, particularly people of color, low-income people, and people who live in rural areas.

Under these conditions, advocates say the FDA’s decision to ignore the scientific consensus around mifepristone is inherently political. They argue that to continue restricting the use of the drug means siding with the anti-abortion camp. And indeed, the FDA’s cease and desist letter to Gomperts was met with praise from more than 100 anti-choice members of Congress.

“The FDA is over-regulating medication abortion at a time when we’re seeing increased barriers to abortion care, including efforts to ban abortion outright,” said Andrea Miller, the president of the National Institute for Reproductive Health (NIRH). “We’re concerned that the FDA is playing into political gamesmanship.”

The FDA’s restrictions on mifepristone went into effect the moment the drug was approved in 2000. Jane Henney, the FDA commissioner at the time, said the restrictions—known as the Risk Evaluation and Mitigation Strategy, or REMS—made it possible for the agency to approve the drug in the first place. The only clinical data on mifepristone in the late 1990s came from Europe, and though it had been used there for decades, FDA officials weren’t sure that the drug's safety profile overseas would hold if it came to the U.S.

Henney said that requiring mifepristone to be administered in person by a licensed medical professional meant the agency could closely monitor the use of the drug, and collect its own safety data.

“Ironically, we implemented the restrictions to make the drug available,” Henney said. “But we also wanted to make sure there would be extensive record-keeping: There needed to be a way to gather evidence about how the drug was being used in the U.S.”

For almost two decades now, doctors in the U.S. have been prescribing mifepristone in combination with misoprostol to end pregnancies up to 10 weeks along, a procedure known as medication abortion. Patients first take mifepristone, which stops the pregnancy from progressing, and follow up with misoprostol, which effectively prompts a miscarriage. According to the Centers for Disease Control and Prevention, medication abortion made up about 25 percent of all U.S. abortions in 2015. In France and the United Kingdom, which don’t have the same restrictions on mifepristone as the U.S., the rate of medication abortion is as high as 90 percent. Though the drug can have serious side effects like excessive bleeding and infection, research shows these outcomes are rare: A 2015 study showed that the rate of hospitalization as a result of medication abortion was between 0.01 and 0.03 percent.

If the FDA chose to reevaluate its mifepristone regulations, it wouldn’t be the first time. The administration revised its guidelines for the drug in 2016 after approving an application from the company that markets Mifeprex, brand-name mifepristone. Based on the company’s recommendations, the FDA made changes to the dosage, the way it's taken, and the recommended length of time people should wait before taking the second medication. Crucially, the FDA also removed the requirement that misoprostol be administered in person at a clinic or hospital, but left the restriction on the books for mifepristone.

The FDA made the change based on a large-scale review of the medication, which found that where patients took misoprostol—be it in a clinic or at another location—had little impact on its effectiveness. The agency didn’t address why research that had found the same to be true of mifepristone was insufficient for the FDA.

As commissioner, Henney oversaw the restrictions on mifepristone that remain in place to this day. But in June, Henney spoke out against them for the first time in a commentary for the New England Journal of Medicine, urging the FDA to reevaluate its position on the drug. “Removing access barriers to this medication has a significant effect on the ability to obtain safe abortion care,” she wrote with co-author Helene D. Gayle, who co-chaired a national review on the safety and quality of abortion care in 2018.

“I think the decision we made in 2000 was the right one,” Henney told VICE. “It was right to be cautious about how it was dispensed, and to make sure it had no worse side effects than what we saw in other data. But now we know more about the side effects and the safety profile for mifepristone is [better] than the one for surgical abortion or pregnancy, for that matter. It’s time to re-review the drug.”

Henney has a small army backing her up. On the heels of her NEJM piece, almost 80 reproductive health organizations and individual physicians signed an open letter, accusing the FDA of becoming a “pawn to advance a political agenda that aims to deprive people of their dignity and humanity,” and pressing them to roll back the restrictions. Weeks later, the World Health Organization (WHO) updated its own official guidance on medication abortion by removing its mandate that the drugs be taken under “close medical supervision,” putting the U.S. at odds with global standards for public health.

And this is just the latest wave of criticism: The American College of Obstetricians and Gynecology, the ACLU, and a group of doctors and academics issued calls for the FDA to change its policies in 2016 and 2017.

“People begin to question the legitimacy of the FDA as a scientifically based entity when there’s so much public outcry urging the FDA to do its job appropriately,” said Miller, whose organization, NIRH, signed the open letter. “The FDA should be operating in a way that promotes the health and well-being of people in this country.”

In a statement to VICE, the FDA argued it is doing exactly that. A spokesperson said the FDA continues to maintain its rules around mifepristone to protect Americans, especially those who might try to buy the drugs online, beyond the reach of government oversight. (The FDA’s site even includes an explicit warning not to buy mifepristone over the internet.) “Certain distribution restrictions are necessary to ensure the safe use of the drug,” a spokesperson said in an email. “The distribution of unapproved mifepristone for medical termination of early pregnancy side steps these risk mitigation requirements and can put the safety of patients in jeopardy.”

Reproductive health organization Plan C has stepped in to mitigate harm in the absence of updated FDA regulations. The centerpiece of Plan C’s website is a “report card” that rates online retailers of mifepristone and misoprostol, assigning them a grade based on their pricing, shipping time, product quality, and physician oversight. According to Plan C, Aid Access is the gold standard of abortion-pill suppliers. At $90, Gomperts’ pills (which are shipped directly from a manufacturer in India) are the least expensive—others range in price from $115 to $430. She’s also the only licensed physician running an online abortion pill service: She has a consultation with each of her patients, writes their prescriptions herself, and follows up with them if necessary.

“I’m not just some person without a license and no quality control," Gomperts said. "I know that the medicines I send to women are properly produced in India, at WHO-licensed factories. And I know that the counseling I give to women is accurate. I give good guidance and good advice.”

But the report card shows that even sites without physician oversight are selling legitimate meds. Anyone who orders medication from the seven other sites listed on Plan C can expect to receive an intact package of pills.

“It’s safer than Viagra to use this method of ending a pregnancy, and that includes people taking these pills from a clinic as well as ordering them online,” said Plan C cofounder Amy Merrill.

Advocates say that by targeting Aid Access and maintaining the restrictions on mifepristone, the FDA is stubbornly resisting the future of abortion access. As attacks on abortion rights continue to chip away at Roe v. Wade—which could get overturned completely, or undermined to the point of meaninglessness—more people are going to take matters into their own hands: A study from the Guttmacher Institute found that in a 30-day period in spring 2017, there were more than 200,000 U.S. Google searches for at-home abortions. But whereas that once meant using a coat hanger or other crude, DIY instruments to end a pregnancy, the advent of abortion pills means self-managed abortion no longer carries with it the same health risks.

“It’s safer than Viagra to use this method of ending a pregnancy, and that includes people taking these pills from a clinic as well as ordering them online."

“Before Roe, abortion outside of a legal clinic meant imminent harm,” said Robin Marty, the author of Handbook for a Post-Roe America. “Being able to use this medication is going to change quite a bit about what abortion will look like in the future.”

The future Marty speaks of will occur with or without the FDA’s stamp of approval, either via pill sites or underground provider networks. Some have argued that if the FDA were truly concerned about people buying unsafe mifepristone online, the agency would stop over-regulating it, and catch up not only with global health standards and scientific consensus, but the realities of the everyday Americans it claims to protect.

The restrictions on mifepristone—combined with 18 state bans on telemedicine abortion, which prohibit patients from consulting with providers remotely—are precisely the reason why many people have begun to seek out pills on the internet, advocates say. While the sites currently in operation may be selling the real thing, they worry that attacks on abortion may eventually force people into more shadowy corners of the web.

“It would appear that some of these restrictions may be driving women to do something that has an element of risk,” Henney said. If the agency removed the in-person requirement, Henney continued, “the FDA could at least assure that people would be getting the safe product that they needed.”

Doctors and researchers are trying to take advantage of the renewed attention on the FDA's resistance, and are undertaking new projects to prove to the agency that taking mifepristone outside of a clinic or hospital setting is safe.

Daniel Grossman, a professor of obstetrics and gynecology at the University of California, San Francisco and the director of Advancing New Standards in Reproductive Health, is currently leading a study looking at the safety and effectiveness of dispensing mifepristone in U.S. pharmacies. Grossman conducted similar research last year, concluding that making the drug available in pharmacies would “likely improve access to early abortion in the United States without increasing risks to women.” Grossman’s latest study is FDA-sanctioned, allowing him and his colleagues to run a pilot program in the U.S. based on their previous findings.

The pharmacy model means that though patients would still have to see a doctor in person for ultrasound confirmation that their pregnancy isn't ectopic—or in the fallopian tubes—they wouldn’t have to go to an abortion clinic. (While there are roughly 68,000 pharmacies in the U.S., the number of abortion clinics hovers around 800, according to Guttmacher Institute.) Instead, primary care physicians could write a prescription for the abortion drugs and send it to a nearby pharmacy, where patients could pick up the medication as they would any other prescription drug. Both Canada and Australia have shed their restrictions on mifepristone in favor of this method. (It bears noting that, even now, some pharmacists refuse to fill prescriptions for misoprostol for miscarriage management on the suspicion that people are actually having an abortion. Six states allow pharmacists to refuse to fill birth control.)

Grossman is also about to start another study testing the safety and effectiveness of mailing mifepristone and misoprostol directly to patients’ homes, more closely mirroring the way websites illicitly selling mifepristone function. Gynuity Health Projects, a reproductive health research organization, has been conducting this research for the last three years in Hawaii, where patients can receive both mifepristone and misoprostol by mail as part of the study.

At the University of Texas, Aiken will continue to collect data from Aid Access, closely tracking patients’ experiences, and conducting in-depth interviews with people who have ended their pregnancies by taking the pills Gomperts prescribed them.

Gomperts and Grossman both hope the outcomes of these studies help sway the FDA, but neither feels terribly optimistic that the agency will rescind the mifepristone restrictions anytime soon: Gomperts continues to see the FDA as an inherently political institution; Grossman sees it as an inherently capitalist one. According to Grossman, there’s little precedent for the FDA changing its REMS on a drug without first receiving a request from the company that sells it. In the case of mifepristone, that company is Danco Laboratories: Danco told VICE that it has not submitted an application to the FDA to remove the REMS and declined to comment on whether or not it has future plans to do so.

“The reality is that our drug regulatory system is really a commercial system; it regulates the business of pharmaceuticals,” Grossman said. “I’m not holding out much hope that the FDA is going to take action related to medication abortion simply out of interest in public health.”

The FDA hasn’t issued a second notice to Gomperts, but a spokesperson told VICE that if she continues operating Aid Access she could be subject to “FDA regulatory action, including seizure or injunction, without further notice.” The agency declined to comment on any potential further action in Gomperts’ case, but added, “We remain very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet, because this bypasses important safeguards designed to protect women’s health.”

It’s disappointing for many to think back on the promise mifepristone represented when the drug was first submitted to the FDA for consideration. Reproductive health advocates believed it would revolutionize abortion access. In the midst of the 1990s, a decade that saw some of the most severe clinic violence to date, the idea of a pill you could take in the privacy of your own home—safe from swarms of anti-abortion protesters—was an exciting prospect. And at the time, some advocates felt optimistic it would become a reality: They believed the FDA would allow pharmacies to dispense the drug, and thought that eventually it would be made available over-the-counter (something the American Medical Association called for in December 2000). Family doctors had been “excited about expanding their services,” Elisa Wells, Merrill’s cofounder at Plan C, told VICE in 2017.

In August, the FDA approved GenBioPro's generic mifepristone pill, which also holds an empty promise: While a generic version of the drug could lower the costs associated with medication abortion, doctors don’t expect it to significantly improve access to abortion because of the ongoing restrictions on mifepristone. (GenBioPro did not respond to VICE's request for comment on whether it intends to ask the FDA to remove the REMS.)

Instead of transforming the abortion landscape, mifepristone was embattled from the start, and it’s required advocates to keep up a near-constant fight for access over the last two decades. Gomperts’ clash with the FDA is just the latest chapter. Thinking about it, it seems ridiculous to her that a doctor in Amsterdam should be responsible for closing gaps in access to abortion in the U.S., a country where, on paper, abortion is legal.

Still, Gomperts isn’t flippant about the FDA’s warnings. She takes her work seriously, and won’t tolerate the notion that she’s “violating” the FDA’s rules, or breaching medical ethics—she’s a licensed doctor, and a longtime abortion provider, she said. She knows that the counseling she gives is sound, and that the medicine she prescribes is legitimate. Gomperts said she won’t let the FDA keep her from her work; she’ll fight the agency in court if she has to.

“As a doctor, my only duty is to serve my patients in a way that’s in the best interest of their health—that’s the vow I took,” Gomperts said. “I keep my patients above everything, and that’s what I’m doing.”

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