A Supreme Court case that will determine the fate of Roe v. Wade—the landmark ruling that legalized abortion nationwide—has intensified pressure to permanently nix a requirement to only give out pills ending early pregnancy in-person.
Doctors, abortion rights advocates, and some members of Congress say ensuring easy access to the drug mifepristone is especially critical now that abortion protections are at stake. The high court hears argument Wednesday in Dobbs v. Jackson Women’s Health Organization, a Mississippi appeal that seeks to overturn Roe.
“It is long past time for the FDA to put science ahead of stigma and remove the medically unnecessary restrictions on the medication abortion drug mifepristone,” Rep. Carolyn Maloney (D-N.Y.), chairwoman of the House Committee on Oversight and Reform, said in a statement emailed to Bloomberg Law.
The Food and Drug Administration suspended its dispensing requirement, for the duration of the Covid-19 public health emergency, that patients physically visit a licensed health provider to obtain mifepristone. It’s now reviewing whether to remove the rule beyond the pandemic.
The agency is looking to see if evidence indicates that mifepristone is still safe and effective when patients pick it up at pharmacies or by mail.
The review includes “an examination of recent information from the sponsors of the new drug application and abbreviated new drug application, as well as relevant scientific information from other sources, including published literature,” an FDA spokesperson said.
Meanwhile, calls for permanently removing mifepristone’s risk evaluation and mitigation strategy (REMS), a drug safety program that the FDA can use to make sure the benefits of a medication outweigh its risks, have grown on Capitol Hill.
Maloney introduced a resolution in August with more than 70 other House Democrats urging the FDA to remove restrictions on mifepristone and advance other “equitable, science-based policies governing access to medication abortion care.”
Proponents of abortion access are bracing for the fallout should the Supreme Court overturn Roe or uphold the Mississippi law at issue—which bans nearly all abortions after 15 weeks of pregnancy.
A decision upholding that law would give states new license to slash abortion access. And about a dozen states already have laws largely barring abortion that would be triggered if Roe is overturned.
If Roe is overturned, people living in states with abortion restrictions could still get mifepristone through telemedicine from a doctor practicing in a different state—but only while the public health emergency is in place.
The FDA in April temporarily lifted the dispensing requirement on mifepristone after women’s health-care providers sued the agency in May 2020, citing safety concerns among the rapid spread of Covid-19. The case was subsequently dismissed.
Since the requirement was lifted, telemedicine and mail-order pharmacies have distributed mifepristone to patients seeking early-stage abortions across the country, and both doctors and abortion rights advocates say that safety data supports the rule’s permanent removal.
“The science is very clear,” Kirsten Moore, director of the Expanding Medication Abortion Access (EMAA) Project, said. Moore started the project in 2018 to specifically push the FDA to change the way it regulates abortion medication.
“Not only is medication abortion care safe and effective, but allowing telemedicine and mailing medication” has shown to be as well, Moore said.
Mifepristone, together with misoprostol, can be used to end a pregnancy within 70 days of a person’s last menstrual cycle. Misoprostol doesn’t face the same dispensing requirement; the FDA has only approved it to prevent and treat gastric ulcers from anti-inflammatory drugs though doctors widely prescribe it for abortion.
Mifepristone has been subject to access and distribution restrictions since the FDA first approved it more than two decades ago—limits that researchers and activists agree are no longer necessary.
The FDA’s website says “certain distribution restrictions were necessary to ensure the safe use of that drug” when it first reviewed and approved the new drug application for Mifeprex—the brand-name version of mifepristone—in 2000.
In 2011, the restrictions were converted to REMS. That program stipulated that Mifeprex and its approved generic version could only be dispensed in-person at clinics, medical offices, hospitals, or through another certified prescriber.
The restrictions were imposed due to questions on “whether the rate and severity of adverse events would be similar or greater with mifepristone than with surgical abortions,” Jane Henney, who served as FDA commissioner when the drug was first approved, said in a 2019 article she co-authored for the New England Journal of Medicine.
“Given the available scientific evidence at the time, we believe that the decision to approve mifepristone was the right one, as was the FDA’s judgment with regard to initially limiting its distribution system,” Henney wrote. But since 2000, “accumulated knowledge about mifepristone strongly suggests that the current restricted distribution system is not aligned with the limited risks that are now known.”
Moore said differing perspectives on the effectiveness of the REMS requirements have so far prevented the FDA from making long-term changes.
She said that former FDA officials have told her, “You look at that track record and say the drug is safe; FDA looks at that track record and says the REMS are working, the REMS are why that drug has that safety track record.”
‘Doesn’t Make Sense’
The body of research on mifepristone has grown since 2000, and researchers say studies conducted throughout the pandemic suggest that there is no longer a valid medical reason to retain the in-person requirement.
“Now, after 21 years of experience here in this country with this medication, and millions of patients who have used the medication safely and effectively, it [REMS] just doesn’t make sense anymore,” said Daniel Grossman, a professor at the University of California, San Francisco.
Grossman, who directs Advancing New Standards in Reproductive Health (ANSIRH) at the UCSF Bixby Center for Global Reproductive Health, led a review in September examining patient outcomes in four studies in which mifepristone was dispensed at locations other than clinics or hospitals, including a brick-and-mortar pharmacy and via mail-order.
Each of the four studies showed that “medication abortion provided without in-person dispensing of mifepristone is effective and safe, with findings similar to studies of medication abortion provided with in-person clinician dispensing,” according to an ANSIRH document outlining the evidence.
The suspension of the in-person rule has helped ensure “patients in eligible states have been able to access needed abortions without the other burdens they regularly face as a result of these unscientific barriers,” said Jen Villavicencio, lead for equity transformation at the American College of Obstetricians and Gynecologists—one of the providers behind the 2020 lawsuit against the FDA.
That’s especially true, she said, for people who “may have previously had to travel long distances to see a dispensing clinician, people who have to take time off from work, or people who have to find childcare.”
Some states still have their own obstacles to mifepristone that will remain even if the FDA permanently lifts the dispensing rule, researchers and abortion rights activists say.
Alabama, Texas, and 17 other states, mostly Republican-controlled, require clinicians providing medication abortion to administer the drugs in-person, effectively barring access via telemedicine or mail-order, according to the reproductive health-care research firm Guttmacher Institute.
The FDA’s role is to determine the safety and effectiveness of the drug and authorize it for use. Beyond that, states may still impose their own access restrictions if the agency decides to lift its own.
“Maybe there’s future litigation here,” Moore said. “It is just kind of ridiculous to think that FDA approved this drug and a state legislator, a state lawmaker can say you can’t have that drug.”
The FDA, for its part, is limited to acting within its regulatory authority to evaluate the safety and effectiveness of drugs and medical devices. Even if Roe is overturned, the agency will continue regulating mifespristone for medically terminating early pregnancy consistent with applicable law and regulations, the spokesperson said.
But if the FDA is “following the science,” Moore said, the change to the REMS requirements “will be made permanent.”