The 5th Circuit’s new abortion pill ruling targets patients.
On Wednesday, the U.S. Court of Appeals for the 5thCircuit announced a decision in a closely watched case concerning the first drug in the FDA-approved medication abortion regimen: mifepristone. It’s important to note at the outset that regardless of the court’s reasoning, in the short term, nothing will change regarding the way abortion pills are accessed or regulated. Earlier this year, the Supreme Court issued a stay that will maintain the status quo until itmakes a final decision on this case. However, it is equally important to understand that this decision, if it were to take effect, will cause a radical departure from the standard of care and sow deep confusion.
Last year, after the Supreme Court overturned Roe v. Wade, a group of antiabortion plaintiffs challenged the FDA’s 2000 approval of mifepristone and subsequent regulatory actions in 2016 and 2021 that loosened the agency’s exceptional and unnecessary distribution limitations for the drug. A Texas district court judge with a history of antiabortion views agreed with the plaintiffs and issued an injunction that would have suspended the approval of mifepristone nationwide. After two weeks of intense legal wrangling, the Supreme Court stayed the injunction throughout the entire course of litigation.
The Supreme Court also sent the case back to the 5thCircuit, a federal appeals court, to review the case more fully. Yesterday, that court released its decision. In it, the majority of a three-judge panel found that the plaintiffs’ challenge to the brand-name and generic approvals of mifepristone faced procedural issues that made their claims unlikely to succeed. As a result, the court would not suspend the drug approvals. This is a significant deviation from the lower court decision and an undeniable win for the FDA.
AdvertisementHowever, the panel found that the FDA’s subsequent ease of restrictions was likely to be arbitrary and capricious under the Administrative Procedures Act, preliminarily enjoining those later FDA decisions. Though, again, this opinion will take effect only if the Supreme Court refuses to hear the case (or ultimately agrees with the 5thCircuit). Its effects would be enormous.
Advertisement Advertisement AdvertisementThe 5thCircuit’s order would take us back to the regulatory regime in 2016, before the FDA modified mifepristone’s label and distribution limitations. The old drug label approved mifepristone only through seven weeks of pregnancy, not the 10 weeks through which it is currently approved. The original label also instructed doctors to use a higher dose—triplethe currently approved dose—which comes with greater, negative side effects.
AdvertisementMoreover, before 2016, the FDA attached even more distribution limitations than it does today, which were especially onerous: Only physicians were permitted to prescribe the medication (excluding nurse practitioners, midwives, and physician assistants); more importantly, patients had to pick up and even take the medicine at a clinic, rather than having it mailed to take at home. Patients often had to visit a clinic multiple times, thwarting the primary benefit of a medication abortion.
In 2016 and 2021, after careful study and review of the safety and effectiveness evidence, the FDA extended the gestational limit for the drug, lowered the dose, and lifted these distribution restrictions (though it kept several others in place that state officials and groups are challenging in other litigation). These changes are supported by peer-reviewed evidence and medical practice around the world and have been responsible for an uptick in medication abortion usage in this country. But the 5thCircuit would have the country revert to an era of outdated information and medical practice that belies what is best for patient health and hampers access to a safe and effective drug.
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Read MoreReturning to these increased restrictions on mifepristone would have widespread and harmful impacts everywhere, including in states that permit abortion. There would be fewer abortion providers thanks to the physician-only rule, and clinics would no longer be allowed to mail mifepristone. Returning to in-person care, especially if it involved multiple visits, would increase the cost of abortion and overwhelm the brick-and-mortar clinics right as they are strained from the influx of out-of-state patients. Virtual clinics that counsel patients online and mail pills could no longer provide abortion care with mifepristone. The recent rise of abortion by telehealth has become a necessary part of our abortion ecosystem in this crisis moment.
AdvertisementDespite these challenges, the 5thCircuit’s judgment, if ultimately enforced, will not stop medication abortion and would not necessarily mean returning to a previous era of medication abortion practice. First, physicians regularly prescribe drugs off-label, so they could—and almost certainly would—continue to prescribe mifepristone through 10 to 12 weeks of pregnancy and at the current lower dose. However, the drug company is not permitted to market or distribute the drug with an unapproved label. The process of changing a drug’s labeling is not simple and could take time, which could result in a short-term nationwide disruption in patients’ ability to access mifepristone while the manufacturer works to reimpose the old labeling. To combat this, the FDA could use its enforcement discretion to give the manufacturer a temporary reprieve while it makes these changes.
Advertisement Advertisement AdvertisementSecond, nothing in this litigation pertains to the second drug in a medication abortion, misoprostol, which across the world is taken on its own to end pregnancy. Indeed, the World Health Organization lists misoprostol as an essential medicine that is a safe and effective form of medication abortion. This drug is approved by the FDA for ulcer treatment and was notchallenged in this or any other case. That means that providers may switch to off-label prescription of misoprostol-only abortions and continue to provide this form of abortion with advanced practice clinicians, through 10 or 12 weeks of pregnancy, via telehealth and mailed pills. But the gold standard, for comfort and efficacy, is the two-drug regimen with mifepristone. The 5thCircuit’s decision would mean a less-than-optimal regime for patients.
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Third, this case will have no impact on the online market for pills outside the formal health care system, both internationally and domestically. People will still be able to access both mifepristone and misoprostol through these informal networks. Indeed, if mifepristone becomes harder to access legally and through health care providers, we know from history as well as current practice that many will choose to access it in other ways. Obtaining pills outside the formal health care system is safe and, in most cases, cheaper, as has been proved by the various medical care providers and informal networks helping patients access these drugs in states that have criminalized abortion care since the Supreme Court struck down Roe v. Wade. But many patients prefer the comfort and expertise of a provider, and the 5thCircuit’s decision will make it harder to access.
These realities make clear that if this case were ultimately ever successful, even partially, it would serve only to harm patients, despite its pretextual purpose of promoting “patient safety.” It would return the drug to a label with greater side effects, hamstring providers into offering a slightly less effective regimen, and force many patients outside the formal health care system. This case has nothing to do with “protecting women,” but rather ending abortion at pregnant people’s expense.
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