“The evidence is crystal clear: Mifepristone is safe and effective, and the FDA’s unique restrictions provide no safety benefit while severely burdening patient’s ability to access care. … If the FDA follows the science, we should soon see the removal of these barriers to care.”
—Julia Kaye, staff attorney at ACLU’s Reproductive Freedom Project
On Friday, May 7, the Biden administration announced that the U.S. Food and Drug Administration (FDA) will undertake a review of longstanding restrictions on the medication mifepristone used for miscarriage and abortion care. The announcement came as part of a joint legal filing in the ACLU lawsuit Cheslius v. Becerra, challenging the restrictions.
“This is promising news, and reflects the Biden administration’s commitment to follow the science,” said Kirsten Moore, director of Expanding Medication Abortion Access Project.
The announcement follows an FDA decision last month to lift in-person dispensing requirements on mifepristone for the duration of the pandemic.
“The FDA decision to comprehensively reevaluate restrictions on mifepristone coming on the heels of the FDA decision to suspend the in-person requirements during the COVID-19 public health emergency feels like, finally, science and common sense have a foothold on this issue and some long overdue progress,” said Julia Kaye, staff attorney at ACLU’s Reproductive Freedom Project which represents the plaintiffs in Cheslius v. Becerra.
The FDA was facing a Friday deadline to file a brief defending their mifepristone restrictions. The parties agreed to stay the litigation until December 1, 2021.
“There is no reason why patients in abortion and miscarriage care should be singled out for unjustified and burdensome regulations,” Kaye told Ms. “We are very hopeful that the outcome of the FDA review will be a full elimination of the restrictions.”
Approved by FDA for use during the first 10 weeks of gestation, medication abortion uses two types of pills: mifepristone, which interrupts the flow of the hormone progesterone that sustains the pregnancy, and misoprostol, which causes contractions to expel the contents of the uterus. This combination of pills is more than 95 percent effective and is a safe way to end an early pregnancy. According to the Guttmacher Institute, medication abortion now accounts for over 60 percent of abortions in the first 10 weeks of pregnancy.
Despite its safety, the FDA restricts distribution of mifepristone through a drug safety program called the Risk and Evaluation Mitigation System (REMS). Under this program, the FDA prohibits retail pharmacies from stocking and distributing mifepristone and requires that the medication be dispensed only in certain health care facilities through a certified prescriber.
“The evidence is crystal clear that mifepristone is safe and effective and that the FDA’s unique restrictions provide no safety benefit while severely burdening patient’s ability to access care,” Kaye told Ms. “Leading medical authorities, including the American Medical Association and the American College of Obstetricians and Gynecologists, uniformly call for the elimination of these unjustified restrictions. Given all of that, if the FDA follows the science, we should soon see the removal of these barriers to care.”
Other advocates agree that the restrictions are outdated and not medically necessary.
“Medication abortion care has a 20-year track record as a safe and effective option for ending an early pregnancy,” said Moore. ”We believe the review will confirm why it’s important to eliminate these outdated restrictions. Women should be able to receive their prescription for medication abortion in the way that makes the most sense for them and providers shouldn’t have to jump through hoops to deliver the best care for their patients.”
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The FDA REMS places burdensome requirements on clinicians providing medication abortion services, including requiring them to sign up with the drug distributor, order and stock the medication, give detailed information about the medication to patients and have them sign a consent form, and then label and distribute the pill directly to patients. These onerous requirements limit the number of providers who offer medication abortion and significantly increases the cost of the service for patients.
“It is difficult or impossible for many qualified clinicians to comply with the REMS,” said Kaye. “Specifically, many clinicians cannot get institutional approval to stock and dispense and bill for it on site. It’s extremely unusual to have to act not only as a prescriber but also as a pharmacy to be able to dispense medication on site. Often these decisions necessitate the involvement of many individuals within health care institutions. What this means in practice is that a single individual opposed to abortion or simply intimidated by these unique and complicated logistics can significantly delay or altogether derail a clinician’s ability to provide this to their patients.”
It’s Time to Let Pharmacists Dispense the Abortion Pill
Advocates are demanding that the FDA treat mifepristone like other similarly-safe medications by allowing patients to obtain the drug at a pharmacy with a clinician’s prescription.
“For two decades, outdated restrictions on medication abortion have pushed care out of reach,” said Destiny Lopez, co-president, All* Above All. “The harm falls hardest on people of color working to make ends meet and those living in rural communities. We’re confident that in its review, the FDA will confirm what we’ve long known—that medication abortion care is a safe, effective option for ending a pregnancy. The impact of this decision could be profound, allowing more people to get medication abortion in a way that makes the most sense for them.”
Recent research shows that removal of the in-person dispensing requirement could increase access to medication abortion, including in regions with limited abortion access such as the South and Midwest. One study revealed that 24 percent of obstetricians and gynecologists who did not currently provide medication abortion care said they would offer this option to their patients if the in-person dispensing requirement was removed—which would double the potential number of medication abortion providers. Another study concluded that pharmacist dispensing of mifepristone for medication abortion is effective and acceptable to patients, with a low prevalence of adverse events. The peer-reviewed journal Contraception has a special issue with recent research on mifepristone coming out in July.
“There is a robust body of evidence spanning multiple states and decades confirming that when patients have to travel farther in order to access abortion care, many are delayed, and some are unable to have an abortion at all,” said Kaye. “We see those impacts, even when the travel distance is increased only by 10 to 12 miles.”
The FDA’s announcement comes after years of demands from feminists, lawmakers and doctors to lift the restrictions, including the National Women’s Health Network’s #MailTheAbortionPill campaign. In March, a coalition of 55 reproductive health, rights and justice groups sent a letter and petition with over 200,000 signatures to President Biden urging his administration to lift the FDA restrictions on the abortion pill during the pandemic and permanently. Last year, 109 Members of Congress asked the FDA to lift the REMS restriction. On February 9 of this year, members of the House Committee on Oversight and Reform wrote a letter to FDA requesting it lift the in-person requirement for medication abortion care. The American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians have all issued statements calling for the FDA to lift the REMS restrictions on mifepristone.
“It is long past time for the FDA to comprehensively reevaluate these outdated and harmful restrictions on mifepristone,” Kaye told Ms. “There has been a huge amount of focus on this issue over the past year and growing calls by leading medical experts to take a fresh look at these outdated restrictions. And, of course, on top of that, the pressure from the litigation. So I think a combination of factors grounded in science is what finally pushed FDA to initiate this long overdue review.”
Some advocates expressed concern that anti-abortion forces might try to influence the FDA review. “We’re pleased that the FDA has agreed to review its restrictions on mifepristone, but we’ll be watching carefully to make sure that they follow the science,” said Cynthia Pearson, executive director of the National Women’s Health Network (NWHN). “Anything less than permanently lifting all of the restrictions will be a capitulation to anti-abortion pressure.”
Lopez warned of state-level barriers to mifepristone. “Anti-abortion legislators in 19 states have enacted politically motivated bans on medication abortion care through telehealth, so we still have work to do,” said Lopez. A new ban on telemedicine abortions in Ohio that was set to take effect last month was blocked by a state court, while others are still advancing in Indiana, Arkansas, Iowa, Alabama, Texas, Oklahoma, Wyoming and West Virginia.
“We hope that the FDA’s scientific review of the REMS will result in a full removal of these medically unnecessary barriers to access,” said Elisa Wells, co-founder and co-director of Plan C. “These very safe pills should be available in pharmacies just like other essential medications. But, simply lifting the REMS is not enough to ensure equitable access. We also need to remove the politically-motivated bans on telemedicine abortion that restrict access in so many states. Everyone deserves modern access to these safe and effective pills, regardless of where they live.”
Since the FDA’s April 12 decision to lift the requirement that doctors distribute abortion pills to patients in-person during the pandemic, telemedicine abortion services have sprung up in states that do not have bans. Providers include Just the Pill operating in Minnesota and Montana, Choix in California, Hey Jane in New York and Washington, carafem operating in Georgia, Illinois, Maryland, New Jersey, Virginia and D.C., and Abortion On Demand in 20 states and D.C. The FDA allows these and other certified prescribers to contract with certain pharmacies to dispense mifepristone, including Honeybee Health, the first U.S.-based online pharmacy to ship abortion pills. This allows physicians to prescribe the drug without having to stock it and distribute it directly themselves. Telemedicine abortion can be much less expensive than in-clinic care—as low as $105—and is supported by the abortion fund ReproCare Healthline. The organization Plan C has a detailed guide to the availability of telemedicine abortion in each state.
These telemedicine abortion providers are revolutionizing early abortion health care in the U.S.—a change the FDA could make permanent by ending the REMS restrictions on mifepristone.
“We’re really optimistic that that the science will prevail and FDA will be able to loosen the restrictions on women’s access to a safe, effective option for ending an early pregnancy,” Moore told Ms.
And what does this mean for women seeking abortion? “Hopefully that they get to go to their own doctor and get a prescription then have the prescription mailed to them at home and they can manage the abortion process at home with the comfort of their own family and friends around them.”