Mifepristone: Supreme Court Keeps Abortion Pills Legal—At Least For Now—Blocking Ruling

By Alison Durkee

On April 21, 2023

TOPLINE

The abortion drug mifepristone will remain broadly available while a case challenging its legality gets appealed, as the Supreme Court ruled Friday to block a controversial lower court ruling that revoked the pill’s government approval.

KEY FACTS

The Supreme Court’s decision to reject restrictions imposed by a lower court comes after Justice Samuel Alito initially paused a lower court’s ruling until Wednesday and then extended that pause through the end of the day Friday.

U.S. District Judge Matthew Kacsmaryk ruled April 7 to throw out mifepristone’s approval by the Food and Drug Administration, siding with anti-abortion advocates who argued the FDA shouldn’t have approved it.

The 5th Circuit Court of Appeals then partially blocked that order on April 12, keeping mifepristone broadly legal while the case is appealed, but reinstating some restrictions on the drug that require it to be dispensed in person only for the first seven weeks of pregnancy.

The Biden Administration had asked the Supreme Court to pause Kacsmaryk’s ruling while the case makes its way through the 5th Circuit—keeping mifepristone broadly legal without restrictions—or else take up the case for oral arguments.

The Biden Administration argued letting the lower court rulings take effect would cause “profound disruption and grave harm” by taking away patient access to mifepristone and “unnecessarily burdening the healthcare system” by forcing patients to undergo surgical abortions instead, while the plaintiffs who challenged the drug’s approval argued the 5th Circuit’s restrictions on the drug are “safety guardrails” that should be left in place.

WHAT TO WATCH FOR

The Supreme Court’s ruling means mifepristone will remain broadly legal as it’s heard before the 5th Circuit—and then, if necessary, before the Supreme Court. The availability of mifepristone will be unchanged during that time from its status before Kacsmaryk’s ruling came out. The 5th Circuit said in its previous ruling that it will take up the case on an expedited basis and hear it during its next oral arguments calendar, but there isn’t a specific date yet for when that will take place.

BIG NUMBER

53%. That’s the percentage of all abortions in the U.S. that were medication abortions in 2020, the most recent year for which data is available, according to the pro-abortion rights Guttmacher Institute. Of those, researchers for the Guttmacher Institute found more than 98% were done using mifepristone, which is taken as part of a two-drug regimen with misoprostol.

TANGENT

Kacsmaryk’s ruling blocking mifepristone’s approval came at nearly the same time as a separate ruling out of Washington, which actually expanded access to mifepristone in Democratic-led states that brought the lawsuit. That court said in an April 13 order that Kacsmaryk’s order was not in effect when it ruled, and the Biden Administration cannot alter the status quo of mifepristone’s availability in the states that brought the lawsuit irrespective of the other case. GenBioPro, which manufactures the generic version of mifepristone, has also sued the FDA in an effort to keep the drug legal if the 5th Circuit’s ruling goes into effect, threatening the generic drug’s approval.

SURPRISING FACT

Mifepristone having its federal approval revoked or heavily restricted wouldn’t prevent medication abortions entirely, as abortions can also be performed using only misoprostol, which is also used to treat other conditions and thus so far hasn’t been subject to the same kind of restrictions or legal attacks. Typically the second drug taken alongside mifepristone—with mifepristone terminating a pregnancy while misoprostol induces contractions that expel the tissue—misoprostol can also terminate a pregnancy on its own when taken correctly. Though not formally approved by the FDA, the regimen has been endorsed by the World Health Organization as a suitable alternative, and is still considered to be broadly safe and effective.

KEY BACKGROUND

Medication abortion has come under greater threat in the wake of the Supreme Court overturning Roe v. Wade in June, as the abortion method—which is easier to obtain over the mail and take outside of a clinical setting—has become increasingly important to abortion access as states ban abortion and abortion clinics shutter. GOP-led states have also brought legislation targeting medication abortion in addition to the lawsuit challenging mifepristone, with Wyoming becoming the first state to outlaw abortion pills. The lawsuit has led to widespread worry among abortion rights advocates about the impact of mifepristone having its approval revoked, even as legal experts have suggested the judiciary doesn’t have the power to strip a drug of its approval, or there would have to be a lengthy administrative process to withdraw approval. Kacsmaryk’s ruling has also sparked fears it could be used to challenge the approval of non-abortion drugs, such as vaccines or HIV treatments.

This piece was republished from Forbes.