Coming Legal Battles

The Coming Legal Battles Over Abortion Pills

How will the abortion pill be regulated in a post-Roe country? Four big questions about the looming legal battles.

By RACHEL REBOUCHÉ, DAVID S. COHEN and GREER DONLEY

After the disclosure of Justice Samuel Alito’s draft opinion in the Supreme Court’s abortion case, there has been a flurry of commentary about the return to pre-Roe times. Much of that coverage has focused on the expenses and legal intricacies of abortion travel, bottlenecks at clinics in abortion-supportive states and the likelihood of criminal prosecution in anti-abortion states.

These are valid concerns if Roe is overturned, after which about half the states would make abortion illegal. But in one major respect, abortion has changed dramatically since 1973 when Roe was decided: the uptake of medication abortion, the two-drug regimen (mifepristone followed by misoprostol) that ends a pregnancy through ten weeks with pills. In 2020, medication abortion accounted for 54 percent of all abortions.

The anti-abortion movement has prepared for this moment and is already focusing on restricting access to pills, knowing that abortion bans will be far less effective if states cannot keep the drugs from entering their borders. Nineteen states do not allow medication abortion via telehealth, others prohibit sending pills through the mail, and some states are introducing legislation that would ban the drugs entirely. But enforcing those laws will be uncharted territory, with new avenues for evading state bans as well as new legal challenges about whether federal or state law reigns supreme in some instances.

What will anti-abortion states do to restrict access to abortion pills, and what will abortion-supportive states, patients and medical-care providers do in response to those restrictions? Here are four battles over pills on the horizon.

First, the FDA could face increasing pressure to remove or to keep existing restrictions on the first drug in a medication abortion, mifepristone. Since approving mifepristone to end a pregnancy in 2000, the FDA has placed requirements on the drug that are not imposed on drugs with similar safety records. The FDA has modified those restrictions in previous years, and in December 2021, the agency lifted the rule that forced patients to collect mifepristone in-person at a healthcare facility, allowing them to obtain mifepristone through the mail after a virtual appointment.

But other medically unnecessary restrictions remain in place, such as the requirement that healthcare providers who want to prescribe mifepristone become certified — i.e., submit paperwork to the drug’s sponsor — before being permitted to do so. Even though nearly every major medical organization supports removing these restrictions, which discourage various providers from offering medication abortion, stigmatize abortion care and serve no medical purpose, the FDA declined to treat mifepristone like similar drugs. To the contrary, it also required a new certification for pharmacies, which will soon be allowed to dispense the drug for the first time.

Removing these restrictions may only expand abortion access in states that permit it. Still, this could help states that allow abortion scale up their operations to accommodate the surge of out-of-state patients. The FDA may nevertheless be hesitant to reverse its policy lest that decision be painted as political. And regardless of what it does now, if a Republican wins the presidency in 2024, the FDA could seek to impose additional restrictions on mifepristone so that it is harder to access everywhere.

Whatever action the FDA takes — whether to add or remove barriers to accessing medication abortion — it will likely be challenged in the courts, and the crucial question will be whether the agency is following the proper procedures and best science.

Second, there are questions about whether the FDA’s regulation of medication abortion trumps state abortions laws, potentially expanding medication abortion access even in states that attempt to ban all abortion. The U.S. Constitution provides that federal law preempts state law. The United States, the drug’s manufacturer, or a provider could bring a lawsuit arguing that a state cannot regulate medication abortion more harshly than the FDA, a federal entity. It’s clear that states cannot regulate drugs less harshly than the FDA. But whether the FDA’s regulation is just the nationwide floor or is also the nationwide ceiling is a complex question that might be different for different products. If it’s both, then states would not be able to ban an FDA-approved drug, especially one as closely regulated as mifepristone.

The preemption approach already is being tested in one court. The generic manufacturer of mifepristone filed a lawsuit in Mississippi arguing that the FDA’s regulations preempted some of Mississippi’s strict abortion laws. That case is languishing in pretrial motions and has not yet produced a ruling on the preemption issue. But eventually there will be a decision, and additional lawsuits using this theory will likely be filed, some even challenging a general abortion ban after Roe is overturned. Whether or not the FDA enters the fray and participates in this litigation, the agency will likely face pressure from both sides to assert its position on whether its regulations have preemptive effect.

Third, providers might prescribe abortion-inducing drugs for other stated purposes — to start one’s menstrual cycle, for example.

With a practice known as menstrual regulation, or often called “missed period pills,” a patient takes the same medications used in medication abortion to start a period. Because the purpose is to start menstruation for a late period, the medical care provider does not administer a pregnancy test and thus does not know if the patient is pregnant (though the patient might suspect they could be). If the patient is pregnant, the medication induces an abortion; if the patient is not pregnant, it will induce period-like bleeding.

Providing this care may fall outside of states’ abortion regulations because no one is knowingly ending a pregnancy, which is the requirement for criminal abortion bans to apply. And, of course, people can have late periods for many reasons unrelated to a pregnancy.

Menstrual regulation happens as an informal practice in a number of countries, and it is formally recognized as a regulated treatment practice in Bangladesh, which bans abortion. Indeed, forms of menstrual regulation harken back to before the Fourteenth Amendment’s ratification — the historical moment Justice Alito relied on to overturn Roe v. Wade in his leaked draft opinion.

A related strategy would be to prescribe medication abortion in advance so that people have it in case an unplanned pregnancy arises, though that also has its legal and practical limitations. While these strategies might increase the availability of pills in abortion-supportive states, anti-abortion states are unlikely to look the other way if out-of-state providers send pills into their states, for any stated purpose, at any point in time, raising many of the interstate issues we have previously discussed.

Fourth, there will be a push to change the means by which medication abortion is dispensed over the long term, such as FDA approval for over-the-counter use, as occurred with emergency contraceptives (which, to be clear, are entirely different than abortion pills). Given that the FDA has yet to remove the unnecessary extra restrictions that burden mifepristone, the possibility of over-the-counter approval may be decades away. It took years of court battles to get the FDA to finally approve Plan B for all age groups, and some have criticized the FDA for delaying recent efforts to get hormonal birth control approved for over-the-counter use.

As a result, no one should expect over-the-counter access to medication abortion soon, but the battle will come eventually, as researchers and advocates push for innovation to increase abortion’s accessibility beyond current models. In the meantime, abortion-supportive states could experiment with the novel approach of allowing pharmacists to consult with patients and dispense medication abortion, as many states have already done with birth control. The regulations the FDA imposes on mifepristone would make this challenging for the two-drug medication abortion regimen. A misoprostol-only approach, which is safely and effectively used in many parts of the world, were it adopted by providers and supported by research, might address regulatory barriers.

In the next decade, fights over abortion pills will take on a disproportionate share of the litigation and national attention. But they cannot work for everyone — they are not approved after 10 weeks, are contraindicated for some patients and some people will prefer a procedural abortion. Those people still need care from brick-and-mortar clinics.

But for many people who need abortions, the abortion pill has already dramatically changed the reality of abortion care, and innovation spurred by the post-Roe future might just speed up this transformation. Their promise, however, comes with a target, and we can expect pills to be the source of many upcoming state and federal abortion battles.