Mifepristone Manufacturer Asks Supreme Court To Rule On Whether Medication Should Be Restricted

Topline

Danco Laboratories, which manufactures the abortion pill mifepristone, asked the Supreme Court Friday to rule in a case concerning whether the medication can be restricted, teeing up another major abortion case before the conservative-leaning court after it overturned Roe v. Wade.

Packages of Mifepristone tablets are displayed at a family planning clinic on April 13 in Rockville, … [+] Maryland.

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Key Facts

Danco asked the Supreme Court to take up oral arguments in the lawsuit, which was brought by anti-abortion rights advocates and challenges the Food and Drug Administration’s approval of the drug, with Danco arguing the litigation is a case of “indisputable importance.”

Though the lawsuit initially asked for the FDA’s approval of the drug to be totally revoked—which a district judge did grant—the Fifth Circuit Court of Appeals narrowed the scope of the case to just updates made to mifepristone’s approval in 2016 and 2021, which allows the medication to be prescribed via telehealth and delivered through the mail.

Danco argued the plaintiffs that brought the case don’t have standing, as they “do not prescribe or use” mifepristone themselves, and alleged the appeals court erred by striking down the FDA’s 2016 and 2021 guidance.

The Supreme Court previously ruled in the case in April and put on hold the lower court ruling that fully outlawed mifepristone, meaning the abortion drug has remained legal—and available via telehealth and mail delivery—as the case has moved forward.

Whether or not the Supreme Court takes up Danco’s case, and how it rules, will determine mifepristone’s availability, as the high court blocked the lower courts’ rulings until the justices either rule in the case or decide not to take it up—meaning if they reject the case, mifepristone will immediately be restricted.

The Biden Administration, which is also a defendant in the case, has also said it will appeal the Fifth Circuit’s ruling to the Supreme Court, which Danco noted in a statement Friday will be done separately from its filing.

What To Watch For

It’s unclear when the Supreme Court could rule on whether or not to take the case up. If it decides to hear the case, arguments will likely take place during the court’s upcoming term, which begins in October and will end in June 2024, meaning a decision on mifepristone’s fate would come by next summer at the latest. If the Supreme Court does uphold the Fifth Circuit’s ruling and restrict mifepristone, the drug’s availability would revert back to its pre-2016 status, meaning it could only be prescribed and taken in person at a physician’s office. It could also only legally be prescribed through the first seven weeks of pregnancy, rather than ten, as is allowed now.

Crucial Quote

“For the women and teenage girls, health care providers and States that depend on FDA’s actions to ensure safe and effective reproductive health care is available, this case matters tremendously,” Danco wrote in its petition to the Supreme Court, which was first published by CNN and confirmed by the company to Forbes. “And for the pharmaceutical and biotechnology industry, permitting judicial second-guessing of FDA’s scientific evaluations of data will have a wildly destabilizing effect.”

Big Number

9%. That’s the share of all U.S. abortions that were medication abortions facilitated using virtual telehealth providers—which will be outlawed if the Supreme Court sides with the Fifth Circuit—in the six months after the Supreme Court overturned Roe v. Wade in June 2022, according to the Society of Family Planning. The organization found telehealth-based medication abortions increased by 137% between April and December 2022, as states banned abortion and clinics closed, going from 3,610 abortions in April to 8,540 in December. Medication abortion accounted for a majority of the abortions in the U.S. even before the Supreme Court’s 2022 ruling, making up 53% of all abortions in 2020, according to the pro-abortion rights Guttmacher Institute.

Key Background

Mifepristone is one of two drugs used in a medication abortion, along with misoprostol, and has been found to be overwhelmingly safe and effective in terminating a pregnancy. It was formally approved by the FDA in 2000, but attacks on the drug have ramped up in the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization that overturned Roe v. Wade, as state-level bans on abortion made medication abortion more integral to abortion access for people in states where the procedure is outlawed. In addition to the lawsuit, lawmakers have introduced bills targeting abortion pills specifically, with Wyoming becoming the first state to pass legislation explicitly banning the medication (which has since been blocked in court). The Biden Administration has also taken steps to increase access to mifepristone since the Dobbs ruling, moving to make mifepristone available at brick-and-mortar pharmacies, which had not previously been allowed, and issuing guidance saying that under federal law, abortion pills can legally be mailed to states in which abortion is banned. (Despite the federal guidance, states can still make mail delivery of abortion pills illegal—as Arizona does—though it’s logistically difficult to restrict in practice.)

Surprising Fact

If mifepristone gets restricted, telehealth medication abortion could still be provided using only misoprostol. That drug can be taken by itself to terminate a pregnancy, which is widely considered safe and effective—though it carries more side effects than using mifepristone. Misoprostol is also commonly used for other medical issues, making it so far less subject to controversy than mifepristone.