The Supreme Court’s unanimous decision, 9-0, today rejected a challenge to nationwide access to the abortion pill, mifepristone. The justices ruled that the group that disputed the legality of the Food and Drug Administration’s approval of mifepristone—and subsequent regulations pertaining to the drug’s use—didn’t have the legal right to sue. While the ruling effectively preserves the status quo in terms of access to medication abortion, it does nothing to prevent state laws from limiting people’s ability to obtain such pills and even criminalizing their possession, as Louisiana is doing. And the decision has no bearing on future cases which could be brought to the Supreme Court.
In delivering the opinion of the court, Justice Kavanaugh wrote:
“In 2016 and 2021, the Food and Drug Administration relaxed its regulatory requirements for mifepristone, an abortion drug. Those changes made it easier for doctors to prescribe and pregnant women to obtain mifepristone. … The plaintiff doctors do not prescribe or use mifepristone. And the FDA has not required the plaintiffs to do anything or refrain from doing anything. Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain. Under Article III of the Constitution, a plaintiff ’s desire to make a drug less available for others does not establish standing to sue.”
The case that was decided today heard oral arguments this spring. It became evident then that the court would probably reject the plaintiffs’ argument. As the BBC reports, “several of the court’s nine justices sounded skeptical that any of the plaintiffs had suffered harm from the availability of mifepristone—which is necessary to have the legal standing to sue.” Instead their case rested solely on wanting restrictions for others.
According to the Huffington Post, “the case was not dismissed but remanded back to Judge Matthew Kacsmaryk’s courtroom.” Theoretically, if direct and concrete injuries to the plaintiffs were proven the case could be retried, though this is unlikely.
Kacsmaryk is the U.S. District Court judge in Texas who ruled last year in favor of a conservative coalition called the Alliance Defending Freedom, which had filed a lawsuit against access to mifepristone. The group charged that the FDA “illegally approved chemical abortion drugs.” It sought to suspend the FDA’s initial authorization of mifepristone in 2000 and changes the FDA made in 2016 and 2021 to mifepristone’s approved use—no longer requiring an in-person doctor visit and allowing for distribution of the drug by mail.
The FDA approved Mifeprex (mifepristone) and misoprostol for medication abortion in 2000. Mifepristone is a drug that blocks progesterone, which is needed for a pregnancy to continue. When used in conjunction with misoprostol, mifepristone ends early pregnancies (up to 10 weeks following conception). Medication abortion accounts for about more than half of all abortions in the U.S.
The agency’s mandate is to review the safety and efficacy of drugs based on clinical evidence. As such, it is the federal authority on all pharmaceuticals distributed throughout the U.S., including mifepristone and its companion drug misoprostol, indicated for medication abortion.
In addition to bringing about abortions, mifepristone has other common uses, such as treating miscarriages, inducing labor and stopping hemorrhaging.
In today’s decision, the Supreme Court doesn’t weigh in mifepristone’s safety or the FDA’s regulatory authority. And equally important, the ruling doesn’t undo any of the state laws that prohibit medication abortion, or new penalties imposed on individuals for possessing abortion pills.
In fact, Justice Kavanaugh points plaintiffs to how they can achieve their goals when he states in the court opinion that “citizens and doctors who object to what the law allows others to do may always take their concerns to the executive and legislative branches and seek greater regulatory or legislative restrictions on certain activities.”
The legislative and executive branches in the state of Louisiana are presently doing just that.
Louisiana’s Criminalization Of Abortion Pills
Louisiana is criminalizing the abortion pills mifepristone and misoprostol, just two years after the Supreme Court ruling to overturn Roe versus Wade and leave decisions on abortion law to the states. The bill which passed the Louisiana Legislature in May could make it very difficult for women and healthcare providers to access such medications, which have more uses than just abortion. Other state governments could soon follow Louisiana’s lead.
By effectively challenging decisions made decades ago by the FDA, the Louisiana bill sets a precedent in which the agency’s regulatory authority could be subverted with respect to prescription drugs or medical technologies, at the discretion of lawmakers and judges.
The Louisiana legislature is designating the abortion pills as “controlled and dangerous substances.” This typically occurs when a drug is considered addictive, such as opioids, or unsafe in an outpatient setting. The abortion pills don’t fit these descriptions.
Data analyzed by CNN last year demonstrates that mifepristone is considerably safer than common, low-risk prescription drugs, including penicillin and Viagra. There were five deaths associated with mifepristone use for every 1 million people in the U.S. who used the drug between 2000 and 2022, according to the FDA. That’s a death rate of 0.0005%.
Comparatively, the risk of death by taking penicillin is four times greater than it is for mifepristone, while the risk of fatality is 10 times greater for Viagra.
The law will enable Louisiana to track both mifepristone and misoprostol and establish a database of who’s receiving them. It will also make possession of the medication without a prescription a crime with penalties that include a large fine and possible jail time, though an exemption is included in the legislation for pregnant women.
Additionally, the law would require doctors to have a specific license to prescribe the drugs which can only be stored in a limited number of specifically designated facilities, some far from rural clinics.
This could open the door for other Republican states with abortion bans to pursue even tighter limits on the medications. At present, 14 states are enforcing bans on abortion at all stages of pregnancy, with limited exceptions.
The states Missouri, Kansas and Idaho have also opposed the FDA’s approval of the drug in court. The Supreme Court’s decision today does not rule out future legal action from these states. Moreover, the Louisiana bill and legislation that may follow in other states raise challenges to FDA’s charge.
