Why Won’t the FDA Adopt a Truly Bold Playbook on Medication Abortion?

On January 3, the Food and Drug Administration (FDA) quietly made long-awaited changes to the regulations surrounding mifepristone, one of two drugs used in medication abortion. Though the agency merely updated its website without even issuing a press release, the news was met with fanfare: “Abortion Pills Can Now Be Offered at Retail Pharmacies, F.D.A. Says”; “Abortion Pill Could Soon Become Much Easier to Obtain,” headlines proclaimed.

However, experts were immediately concerned that media coverage was overstating the extent to which the decision would materially improve mifepristone access. “I think those initial headlines were very much missing the greater context,” Greer Donley, associate professor of law at the University Pittsburgh Law School, told Truthout.

It’s true that the FDA cleared the way for mifepristone to be dispensed by retail pharmacies for the first time since its approval in 2000. However, the agency left in place a requirement that physicians be certified to prescribe the drug, and created an onerous new pharmacy certification process that will likely limit the number of pharmacies willing to stock it. These regulatory changes fall far short of what professional organizations like the American College of Obstetricians and Gynecologists and the American Medical Association have called for based on evidence showing that mifepristone is safer than commonly prescribed drugs like penicillin and Viagra, and even safer than Tylenol, an over-the-counter drug.

According to experts, the most reasonable and scientific approach would have been to remove restrictions on mifepristone entirely. In fact, scientific evidence would support the FDA going even farther than that to improve access to medication abortion. So why did the agency stop at a half measure?

The reality is that regulation of mifepristone has always been more political than scientific. Despite evidence that the drug was safe and effective from the beginning, its initial FDA approval placed limits on its distribution. Years later, when federal legislation created a formal drug safety approach known as Risk Evaluation and Mitigation Strategies, or REMS, the FDA imposed REMS requirements on mifepristone. Despite some updates over time, the mifepristone REMS always held on to a core component: The drug had to be dispensed in person by certified medical providers only. In practice, this meant abortion providers had to stock the drug on site in offices, clinics or hospitals — a significant barrier to access for which the FDA provided no specific justification. Mifepristone was never available by prescription in a regular retail pharmacy.

However, when the pandemic shut down medical facilities across the country, new venues for access emerged in some states. Data already supported the safety of telemedicine abortion, and in July 2020, the American Civil Liberties Union succeeded in getting a federal judge to block the in-person REMS requirement. This opened the door to medication abortion by mail in the 31 states that allow it. For the most part, certified providers still had to stock the pills, but they could ship them to patients after a telehealth consult rather than dispensing them in person. Though the Supreme Court briefly reversed this decision in early 2021, the FDA announced that it would permanently allow medication abortion by mail at the end of that year.

In fact, it was in that 2021 announcement that the FDA revealed its plan to allow pharmacies to dispense mifepristone — if they followed new certification requirements. This month’s change is merely a finalization of that policy. But in the intervening year, medical organizations, researchers, and other advocates hoped to push the agency toward more comprehensive change.

“Very simply, they could have eliminated the REMS,” Ushma Upadhyay, Ph.D., a professor in the Advancing New Standards in Reproductive Health program at the University of California San Francisco, told Truthout. Mifepristone is only FDA-approved for abortion care, added Upadhyay. Many scientists and medical providers have pushed for the agency to add miscarriage management to its label. “These are two huge steps that would have really demonstrated the FDA’s alignment with science,” she said.

In fact, more than 40 medical and advocacy groups signed on to a letter asking the FDA to approve mifepristone for miscarriage management in October. In the FDA-approved protocol for medication abortion, mifepristone is taken first, followed 24 to 48 hours later by another drug called misoprostol. Misoprostol, which is not subject to REMS, can also be used safely on its own to induce abortion. However, the combined mifepristone/misoprostol regimen is more effective and less likely to require follow-up care. Research shows that the same combined regimen is also more effective for the treatment of miscarriage, but primary care providers and even OBGYNs are often unable to offer this superior option to patients experiencing miscarriage due to mifepristone’s labeling and logistical barriers created by the REMS.

Crucially, noted Upadhyay, adding miscarriage management to the mifepristone label could have enabled pharmacies to stock the drug in states where abortion is banned. “That would really have made a difference, because people experiencing miscarriages are also facing barriers to care because of abortion bans,” she said.

Even in states where abortion is legal, certification requirements are likely to prevent many pharmacies from stocking mifepristone. Mail order pharmacy Honeybee Health — which had been dispensing mifepristone since 2020 under the relaxed restrictions — became the first certified pharmacy under the new requirements on January 3. Encouragingly, Walgreens and CVS quickly announced their plans to become certified as well. However, it’s unclear how many of their locations will maintain certification, as the requirements will be a headache on both the provider and pharmacy side.

“[The FDA] wanted to avoid having a central database of abortion providers,” explained Upadhyay. “Their way around that was to require each individual pharmacy to have documentation of the provider’s certification. So, every time a provider wants to write a prescription and send it to a single pharmacy, they have to fax or email in this other form.” Unlike prescription transfers, she added, there’s no system in place to transfer these certifications. “It’s going to be a logistical nightmare for patients who are trying to get a time-sensitive medication,” said Upadhyay. Each pharmacy will also be required to designate a compliance representative and maintain specific record-keeping practices, an administrative burden not required to stock most other drugs.

In addition to medical consensus that the REMS is simply unnecessary, many experts believe medication abortion is so safe and effective that it should be offered over the counter. Research by some of Upadhyay’s colleagues also found that patients were overwhelmingly satisfied when they received abortion pills dispensed by pharmacists, and Upadhyay says she is aware of research now underway to validate the safety of that approach. This is another option the FDA could have considered.

Another problem with the FDA’s new policy, says Donley, is that it does nothing to circumvent state laws. Thirteen states now have total abortion bans in effect, and a 14th — Georgia — bans abortion at six weeks. But several more states have laws limiting medication abortion access. For example, six of the states where abortion is still legal ban telemedicine abortion, either outright or by requiring that doctors be physically present when patients receive abortion pills — rendering the FDA’s update useless, as pharmacists will likely be unable to dispense pills. And anti-abortion groups and state lawmakers are already gearing up to further limit access in the coming year.

In fact, anti-abortion groups have always been bolder and more aggressive in their strategies than pro-choice Democrats and even mainstream reproductive rights groups. Medication abortion is their next big target. A lawsuit filed in Texas, for example, seeks to overturn the FDA’s approval of mifepristone entirely, arguing that the FDA “chose politics over science” when it approved mifepristone — ironic, given the fact that supporters of abortion rights would argue that the FDA chose politics over science in restricting mifepristone. If even temporarily successful, the suit threatens to ban the sale of mifepristone across the entire country. And it could succeed, because the case will be decided by a Trump-appointed judge notorious for his conservative and “embarrassingly poorly reasoned” decisions.

The Texas suit also puts forward the argument that mailing abortion pills violates the archaic Comstock Act, which outlawed sending “obscene,” “immoral” or “indecent” material through the mail. Though the Justice Department rejected this idea in a recent opinion, using some “smart arguments,” said Donley, like the FDA’s regulation change, it does nothing to counteract state bans.

Rather than be caught unprepared yet again, Donley and her colleagues David S. Cohen and Rachel Rebouche have argued that the federal government could employ bolder legal strategies in ensuring abortion access in a number of ways. For one, they say the FDA could argue that its approval of medication abortion preempts state restrictions.

“The Supremacy Clause of the Constitution essentially says that federal law trumps state law when the two conflict. So, the federal government says that medication abortion is safe, effective and should be permitted to be sold in the U.S. But states are banning abortion, and as part of that, banning the sale of an FDA-approved drug,” said Donley. In other words, there is an argument to be made that a state doesn’t have the power to ban an FDA-approved drug. The idea hasn’t been litigated yet, and while the FDA could work with the Justice Department to adopt this approach, Donley said she doesn’t expect to see that happen.

However, Donley does expect GenBioPro, a maker of generic mifepristone, to test this theory. Though she emphasized that she didn’t have any inside information, Donley pointed to the company’s use of the argument in a lawsuit filed in 2020 in Mississippi. After the Supreme Court overturned Roe v. Wade, triggering a total abortion ban in the state, GenBioPro dropped the suit to reevaluate its strategy, signaling it would continue to litigate the issue.

Given the current makeup of the federal judiciary, having a business advance this argument, rather than the federal government, may prove more successful. “If the goal is to win over some conservatives, which you would have to do for this theory to be successful, then you might think that the FDA and the DOJ are being smart trying to not get involved, because the best way to frame this case is from the perspective of a business interest,” said Donley.

Even so, Donley remains critical of the FDA’s overall approach, and the excitement with which the minor REMS change was met. “I don’t want to downplay it, but the truth is that this is a minor victory at best. It’s not even close to the scale of what the anti-abortion movement is pushing. Something like preemption would be,” she said.

“The FDA has been a huge barrier to abortion access. This decision is really just furthering its abortion exceptionalism,” added Donley. “When our movement applauds something like this as a totally unadulterated victory, when it’s really not, it feeds into [an anti-abortion] narrative that the FDA is our teammate, when that’s really not true.”