“At a time when abortion care is under attack like never before, especially for folks working to make ends meet, we can’t afford partial solutions.”
—Destiny Lopez, co-president of All* Above All
On Thursday, the U.S. Food and Drug Administration (FDA) lifted a long-standing rule that health care providers must distribute the abortion pill mifepristone to patients in person, but left in place several burdensome restrictions that continue to unnecessarily restrict and stigmatize this safe medication, say advocates. The decision came in response to a case filed by the ACLU on behalf of abortion providers and medical groups.
“The FDA’s decision to permanently remove the in-person pill pick-up requirement is a major step forward that will enable many more patients to get this safe and time-sensitive medication as soon as they are ready, without travel-related expenses and delay,” said Georgeanne Usova, senior legislative counsel at the ACLU. “From the person living in a rural community hundreds of miles from the nearest clinic to the patient who wants to access this essential care in the privacy and comfort of their home, the FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”
Mifepristone is used in combination with another medication—misoprostol—to safely and effectively induce a miscarriage in the first 10 weeks of pregnancy. Mifepristone interrupts the flow of the hormone progesterone that sustains a pregnancy and misoprostol causes contractions to expel the contents of the uterus. Unlike mifepristone, misoprostol is not tightly restricted, but is widely available as an ulcer medication.
Sen. Patty Murray (D-Wash.) applauded the decision to remove the in-person distribution requirement for mifepristone.
“For too long, patients have had to jump through burdensome hoops just to get medication abortion that we know is safe and effective,” said Murray. “For some women, that’s meant finding time off from work or finding child care to travel long distances to a clinic, and being harassed as they enter the provider’s facility—all to take a pill that is safe to take at home. That’s why I’m so relieved that today the experts at the FDA are lifting some of these restrictions and making it easier for patients to get and take medication abortion.”
Mifepristone was the only medication out of 20,000 FDA-approved drugs that a patient was forced to pick up in a medical facility but could take at home, unsupervised.
“Today, after reviewing years of evidence on the safety and effectiveness of medication abortion care, the FDA removed some outdated barriers,” said Kirsten Moore, director, Expanding Medication Abortion Access Project (EMAA Project), which advocates for expanding medication abortion access. “The in-person dispensing requirements on medication abortion care have proven to be unnecessary during the pandemic, and the FDA did the right thing today by lifting them. Now patients can see a healthcare professional in a telehealth visit and then have the medications mailed to their home.”
Over the last year and a half, telemedicine abortion startups have opened across the country after a federal court in July 2020 temporarily suspended the FDA in-person distribution requirement as an unconstitutional undue burden during the pandemic. Choix, Just the Pill, Hey Jane and Abortion on Demand are some of the new virtual abortion clinics that now offer telemedicine abortion in more than 20 states.
These clinics screen patients remotely by videoconference or by online forms using a no-test, no-touch medical protocol based on patient history rather than in-clinic exams to determine eligibility for medication abortion. The clinic then prescribes abortion pills to eligible patients using online pharmacies, including Honeybee Health and American Mail Order Pharmacy, which mail the pills to patients at home.
Research tracking the efficacy and safety of fully remote, asynchronous medication abortion care in the U.S. show it is just as safe and effective as in-clinic care. Research also shows that many women prefer telemedicine abortion because it is convenient, private and affordable.
Thursday’s FDA decision means these virtual abortion clinics can continue to operate beyond the pandemic.
“Getting rid of in-person dispensing is good because it allows expansion of telehealth medication abortion,” said Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health (ANSIRH) at the University of California, San Francisco.
FDA Maintains Several Burdensome and Medically Unnecessary Restrictions
Despite lifting the in-person distribution requirement, the FDA kept mifepristone within its highly restrictive Risk Evaluation and Mitigation Strategies (REMS) drug safety program, which tightly controls medications considered dangerous to ensure they are used safely. Under the REMS restrictions, healthcare providers must still register with the drug manufacturer to become certified to prescribe mifepristone, which greatly limits the number of qualified providers.
“The FDA’s failure to remove all of the restrictions on mifepristone ignores the science and smacks of political interference,” said Elisa Wells, co-director of Plan C, which advocates for abortion pill access. “The science is clear: Abortion pills are safe and effective and should be available in regular pharmacies, just like most other drugs,” said Wells. “Removing all of the restrictions would have made it easier for a wider group of clinicians to prescribe them, including family physicians, who are often our most trusted and convenient sources of care.”
Exhaustive research has proven that abortion pills in the first trimester are very safe and effective. The American College of Obstetricians and Gynecologists, the American Medical Association, and the American Academy of Family Physicians have all issued statements opposing the FDA restrictions on mifepristone because they have no basis in medicine and create barriers to time-sensitive abortion and miscarriage treatment.
Francine Coeytaux, Wells’s fellow co-director of Plan C, says the prescriber certification requirement has been a significant barrier to increasing the number of clinicians who can offer medication abortion. Plan C has worked to help providers obtain the certification, but many have been unable to become certified because they work within institutions that will not allow them to apply, according to Coeytaux.
“It remains to be seen how the provider certification process could be modified under this new REMS,” said Grossman. “If it’s a quick and easy online process, great. If it requires filling out a form that is sent in, and there’s a delay in approval, that’s not good. There is a potential to draw in new providers who will start offering medication abortion—but the certification process must be streamlined and providers need to be assured that there is no risk that their identity will be revealed if they sign on.”
The science is clear: Abortion pills are safe and effective and should be available in regular pharmacies, just like most other drugs.
The exact language of the REMS modifications has yet to be determined, says Moore. The FDA will enter into discussions with the two drug manufacturers—Danco and GenBioPro—to determine the modification of the REMS, which could take weeks or possibly months.
Another change in the REMS, however, is likely to reduce the burden on clinicians who prescribe mifepristone: the FDA will allow certified pharmacies to distribute the drug. Advocates hope this will mean more medical providers will be willing to apply for certification and prescribe abortion pills in the future.
“Certified prescribers no longer have to be both doctor and pharmacist—meaning they can just write a prescription and have that prescription filled by a mail-order pharmacy,” said Moore, who hopes that more clinicians will now become certified.
But the FDA is still blocking the abortion pill from being available in pharmacies like any other drug, instead requiring pharmacies to register with the drug manufacturer in order to distribute the drug.
“The FDA has not yet issued guidance about what this certification process will entail. But why is it necessary?” asked Grossman. “Viagra is riskier, yet pharmacies aren’t certified to dispense that.”
Mifepristone is even safer than many over-the-counter medications, including Tylenol, yet remains highly regulated.
“It’s purely political,” said Coeytaux. “These pills should not only be in pharmacies, they should be available over-the-counter. But instead, years later, we’re still in a place where people think of this as a drug that is so dangerous it has to be in a black box.”
The FDA approved mifepristone in 2000, but due to political pressure from anti-abortion politicians and activists, the agency placed the medication under the REMS restrictions, despite strong medical evidence at the time showing the medication’s safety. The FDA has once again caved to political pressure, say advocates.
“We’re supposed to be happy. I don’t feel like we should accept these crumbs anymore,” said Coeytaux. “We’re supposed to celebrate the crumbs, when in fact, it’s egregious. The FDA is supposed to be ruling based on data and evidence, not politics.”
Despite these limitations, the FDA said that it will allow any certified pharmacy to distribute mifepristone—not just mail-order pharmacies.
“It’s good they didn’t limit it to mail-order pharmacies. Brick-and-mortar pharmacies can safely dispense too,” said Grossman.
Brick-and-mortar pharmacies have never before been allowed to distribute mifepristone, even during the FDA’s temporary suspension of the REMS during the COVID public health emergency. The new rule appears to change that.
The FDA REMS will continue to require a patient agreement form, which Grossman describes as “duplicative of the clinic consent form that patients already sign.”
But even with today’s more relaxed FDA rule, many people still face state-level barriers to accessing medication abortion. Nineteen states currently require the prescribing clinician to be physically present when prescribing the abortion pill. Texas recently banned medication abortion starting at seven weeks. Also, 32 states require the clinician prescribing the abortion pill to be a physician, which limits potential providers.
“Eliminating the in-person dispensing requirement may reduce the distances patients will have to travel—but they will still need to be in a state that allows telemedicine medication abortion to have the pills mailed to them,” said Grossman.
Eliminating the in-person dispensing requirement may reduce the distances patients will have to travel—but they will still need to be in a state that allows telemedicine medication abortion to have the pills mailed to them.
If the Supreme Court overturns abortion rights, which they appear likely to do in the case of Dobbs v. Jackson Women’s Health Center argued earlier this month, 26 states are certain or likely to ban abortion, leaving people living in large swaths of the South and Midwest without access to legal abortion healthcare, especially low-income women and women of color.
“While the action today will go a long way for people seeking care, other barriers remain and must be lifted once and for all. At a time when abortion care is under attack like never before, especially for folks working to make ends meet, we can’t afford partial solutions,” said Destiny Lopez, co-president of All* Above All. “The FDA must permanently lift all restrictions on medication abortion and states with politically motivated bans on medication abortion, particularly via telehealth, must reverse these policies so people can get care in a way that makes sense for them.”
To address disparities in access across the states, Sen. Murray is renewing her call on Congress to pass federal legislation to protect abortion rights.
“We can’t lose sight that despite the FDA’s decision, state laws—including in Texas—still ban access to medication abortion through telehealth or by mail, and will prevent patients from getting the healthcare they need,” said Murray. “Extreme Republicans are willing to ignore the science and put their own ideology ahead of patients’ health—so we need to fight back. We must pass the Women’s Health Protection Act, to finally protect the right to abortion at the federal level.”
In the meantime, advocates say they will continue to fight against the remaining FDA REMS restrictions and advocate for expanded access to medication abortion.
“More change is needed,” said Moore. “With access to abortion hanging by a thread nationwide, the FDA must permanently lift all the restrictions on medication abortion care so people can get the care they need in the way that makes sense for them, including by going to their own healthcare professional.”
“The FDA’s decision eliminating its unnecessary in-person requirement did not come a moment too soon, as politicians emboldened by the Supreme Court’s shameful decision in Texas race to impose ever more barriers and burdens on people seeking to end a pregnancy, with outsized harm to communities of color,” said Julia Kaye, staff attorney with the ACLU Reproductive Freedom Project and counsel for plaintiffs.
“With states banning abortion at earlier and earlier points in pregnancy, it is all the more essential that the FDA remove medically unnecessary restrictions that reduce where and how patients can safely fill their mifepristone prescription — and today’s decision is critical progress, though far from complete. We will continue to fight every day for a world where we can all control our reproductive destinies, regardless of where we live, how much money we make, or the color of our skin.”