A common and effective abortion pill can remain available in the United States—for now. But people will only be able to obtain it with significant restrictions, a federal appeals court ruled late Wednesday night.
The ruling from three judges from the U.S. Court of Appeals for the 5th Circuit freezes part of a court order issued late last week from the Texas-based Judge Matthew Kacsmaryk, which ruled to totally suspend the Food and Drug Administration’s approval of mifepristone, one of the two drugs typically used to induce medication abortions in the United States. Rather than agree to totally suspend the approval, the federal appeals court instead ruled that mifepristone should be held to older FDA standards.
This controversial case could rewrite the future of abortion across the country, even in states that protect abortion rights.
Under this ruling, mifepristone must be obtained in-person from a provider—not through telehealth visits, which the FDA agreed to allow after the coronavirus pandemic. Its labeling should instruct providers to only use it to induce abortions prior to seven weeks of pregnancy. The FDA changed that label back in 2016, when it re-labeled mifepristone for use for abortions up to 10 weeks of pregnancy.
The judges also appeared sympathetic to arguments about the Comstock Act, a 19th-century anti-obscenity law that bans the mailing of abortion-related materials but has long been deemed an irrelevant vestigial structure in U.S. law. Since the overturning of Roe v. Wade last year, anti-abortion activists have increasingly seized on Comstock as evidence for a de facto federal ban on abortion.
"To the extent the Comstock Act introduces uncertainty into the ultimate merits of the case, that uncertainty favors the plaintiffs," the judges wrote Wednesday.
Despite the ruling, it is still possible for abortion providers to go “off-label” and prescribe mifepristone for abortions later on in pregnancy. In addition, many abortion providers have said that if mifepristone is yanked off the market, they would turn to the other drug commonly used in medication abortions, misoprostol, to induce abortions.
The overwhelming majority of research into mifepristone has concluded that the drug is safe. Before Roe fell, medication abortions accounted for more than half of all U.S. abortions.
The FDA first approved mifepristone for use in abortions in 2000, but Kacsmaryk’s ruling found that the FDA had violated federal rules during that approval process and cited studies—many of which were conducted by anti-abortion organizations—that suggested mifepristone could have damaging side effects. The appeals court found that it was too late to challenge that 2000 approval, but not too late to review other, more recent FDA changes to the mifepristone’s use.
Regardless of this ruling, this is likely not the last word on mifepristone. The case will likely end up at the Supreme Court.