On Tuesday, the FDA announced the process by which retail pharmacies could become certified to dispense mifepristone, the first drug in the medication abortion regimen. The agency’s decision filled in the details of an announcement made in December of 2021 that patients would no longer be required to go to a clinic to pick up medication abortion and that certified pharmacies would be allowed to dispense it.
This action may be a step forward, but it is far too tepid to fight back against the war that the anti-abortion movement is waging against abortion pills. Meeting this moment will require much more.
First, the FDA has not gone nearly far enough. Lifting the in-person dispensing requirement in 2021 was a game changer: For the first time, online clinics could offer virtual services and mail medication abortion to the states where it is legal. Tuesday’s decision ensures that any pharmacy, including retail pharmacies, can dispense the pills, as well. But this process is stymied by agency-mandated administrative burdens not required for other drugs. For pharmacies that want to dispense medication abortion, the FDA imposed a certification requirement that makes dispensation more challenging. Certification requires, among other things, that a pharmacy agree to certain record keeping, reporting, and medication tracking efforts and designate a compliance representative to do so. These roadblocks are not supported by any science and could limit the number of pharmacies that actually provide abortion pills, blunting the impact of the new rule.
Second, this announcement has come amidst a legal campaign to outlaw mifepristone by judicial fiat—which, if successful, will render the FDA’s decision meaningless. In November, an anti-abortion group filed a lawsuit seeking to invalidate the FDA’s approval of mifepristone, arguing that the decision was arbitrary and capricious. (The agency approved the drug in 2000 after rigorous review.) The suit also alleges that a nearly 150-year-old law known as the Comstock Act bans the shipping of medication abortion, thereby barring online pharmacies from mailing the pills to patients. (The Justice Department has concluded that this long-unenforced law, a relic of the anti-vice era, does not ban mailed abortion pills.)
The plaintiffs strategically filed their case before Judge Matthew Kacsmaryk, a former anti-abortion activist whom Donald Trump elevated to a federal district court in Texas. Judge Kacsmaryk has become notorious for his sweeping, poorly reasoned decisions against the Biden administration. If he issues a nationwide injunction against mifepristone in the coming months, which is entirely likely, the first drug in a medication abortion, mifepristone, could disappear nationwide.
A looming decision could outlaw the first drug in medication abortion nationwide.
It’s hard to overstate the significance of this possibility given that over half of abortions nationwide now take place using abortion pills. Further, medication abortion has helped mitigate some of the worst consequences of the Supreme Court’s decision to revoke the constitutional right to abortion. Clinics that operate entirely online took on many patients, freeing brick-and-mortar clinics to focus more attention on procedural abortion, and healthcare providers stepped up to offer medication abortion that otherwise would not have offered procedural abortion. More patients were able to obtain abortion at less expense and in the privacy of their homes, away from the harassment that plagues brick-and-mortar clinics.
Even with medication abortion, clinics in abortion supportive states are already operating beyond their capacity with weeks-long wait times. If Judge Kacsmaryk removes mifepristone from the market or bans the shipment of pills, his ruling could force all patients to undergo a procedural abortion in a clinic. This would overwhelm clinics, which lack the space and personnel to provide all of those procedural abortions. Weeks long wait times could become months, stalling abortion for everyone in the country.
Compare this potential outcome to the impact of the FDA’s decision on pharmacy certification. The rule will have no impact in states that ban abortion. And even in states that permit it, the agency’s rule only allows pharmacies to dispense medication abortion after becoming “certified,” a potentially lengthy process that costs time, money, and resources. These burdens are compounded by the political costs of dispensing a drug like mifepristone—including harassment, threats, and boycotts—that may make it undesirable for many pharmacies to become certified.
And even if some brick-and-mortar pharmacies become certified (as Walmart and CVS have indicated they plan to do), the impact will be limited. Mail-order pharmacies have been dispensing these drugs for the last few years, so they are already widely available. Even more important, the drugs still require a prescription from a certified provider who follows all relevant state laws governing abortion. In other words, even after the FDA announcement, abortion pills are not going to be on the shelf next to Tylenol any time soon.
Although we should celebrate all victories in this climate, it is not the moment to be complacent with incremental change. To counter the anti-abortion movement’s bold action, we need bold measures.
First, the FDA should remove all the unnecessary barriers that silo and stigmatize medication abortion–including the one announced on Tuesday. There is no evidence-based reason for the FDA to limit which providers can prescribe mifepristone or which pharmacies can dispense it. The agency has kept an unnecessary rule in place, and that is not a victory.
Second, an equally bold litigation strategy as the one in Texas is to argue that the FDA’s regulation of medication abortion preempts state abortion bans. This theory, which has yet to be litigated, could restore access to medication abortion throughout the entire country. If the anti-abortion movement wants to remove medication abortion nationwide, there needs to be a plan to restore it nationwide.
Third, plan for defeats, which will no doubt occur. If mifepristone is removed from the market, there is an alternative to keep medication abortion available: misoprostol. Misoprostol is the second drug in a medication abortion, but it is used throughout the world on its own to terminate a pregnancy. Clinics, providers, and professional organizations need to be preparing to switch to misoprostol-only abortions if mifepristone becomes unavailable. This strategy could keep medication abortion available even if the Texas lawsuit is successful.
The FDA’s move toward greater access for abortion pills is the right direction, but make no mistake: Its decision this week doesn’t go nearly far enough. In this moment, we need an FDA that will push policies that will significantly increase access and a Justice Department that is willing to pursue bold legal strategies to defend the agency’s actions. So far, we haven’t seen it.