The Supreme Court, in its decision on Thursday in FDA v. Alliance for Hippocratic Medicine, ordered the lower court to dismiss a lawsuit challenging the Food and Drug Administration’s regulation of the abortion drug mifepristone because the plaintiffs did not have legal standing to sue.

Justice Brett Kavanaugh wrote the unanimous opinion.

The ruling neither vindicates the safety of mifepristone, nor addresses whether it should be available. It shows only the limits of litigation as part of the strategy to protect women and girls from this dangerous drug.

The FDA approved mifepristone in 2000, deeming it safe only under tight restrictions and close medical supervision. Only doctors could prescribe and dispense the drug, women could obtain it only in person from their doctor, and doctors were required to report all medical complications to the FDA.  

These strict safety rules continued until the FDA, first under President Barack Obama then under President Joe Biden, unraveled them.

Even though overall medical complications were on the rise, the FDA told doctors in 2016 that they no longer had to report nonfatal complications.

Then, in 2021, the FDA cited the lack of evidence of nonfatal complications—a void the FDA itself had created—in dropping the critical safeguard of obtaining mifepristone in person.

With the use of mifepristone on the rise, abandoning these and other long-standing safety restrictions means that more and more women will need emergency treatment for complications from its use.

After unsuccessfully trying to challenge the approval of mifepristone through a petition process within the FDA, medical groups and individual doctors filed this lawsuit in November 2022.

It presented two issues: whether the plaintiffs had legal standing to bring the suit at all and, if so, whether the FDA’s decisions regarding mifepristone were based on sufficient evidence.

The basic standing requirement is that a plaintiff must establish a concrete legal injury caused by the defendant that a court can remedy. On the merits, the Administrative Procedure Act requires that agency decisions must not be “arbitrary, capricious … or otherwise not according to law.”

The District Court said that the plaintiffs had standing and that the FDA’s approval of mifepristone and the decisions to drop its safety restrictions violated the APA.

The U.S. Court of Appeals for the 5th Circuit also recognized the plaintiffs’ standing and found that abandoning the safety rules for mifepristone violated the APA.

The FDA and mifepristone’s manufacturer separately appealed that decision, and the Supreme Court combined the cases. 

The plaintiffs argued that, by making the use of mifepristone less safe, the FDA made it more likely that women will need emergency medical care and, in turn, more likely that these doctors would be required to treat them. That amounted to a legal injury because, by including the need to complete chemical abortions surgically, this treatment would violate the religious beliefs of pro-life doctors and undermine their regular practice of delivering babies.

Kavanaugh explained that to establish standing, a plaintiff must “show a predictable chain of events leading from the government action to the asserted injury—in other words, that the government action has caused or likely will cause injury in fact to the plaintiff.”

These plaintiffs, however, are pro-life doctors and do not prescribe mifepristone. The FDA’s regulations, therefore, do not apply directly to them.

Their standing argument, therefore, was more attenuated. As Kavanaugh put it, they advanced “several complicated causation theories to connect FDA’s actions to the plaintiffs’ alleged injuries in fact.”

The high court did not find any of those theories persuasive.

The core of the decision is this: “The causal link between FDA’s regulatory actions and [the plaintiffs’] alleged injuries is too speculative or otherwise too attenuated to establish standing.”

This decision does not mean that mifepristone is safe; it isn’t. Nor does it mean that the FDA followed a credible and objective decision-making process; it didn’t.

This case was about how the FDA made its decisions, not what decisions it made. Courts address legal disputes; they don’t have authority to make policy decisions. The litigation brought by these brave and determined plaintiffs, however, has exposed the aggressive abortion agenda of the Obama and Biden administrations and their willingness to put women and girls at greater risk to promote it.

Powerful government agencies make decisions and issue regulations that dramatically affect the lives of all Americans. Even when abortion is involved, we must have at least some confidence that these agencies are following the law when doing so.

Mifepristone remains a dangerous drug that now causes more than 60% of all abortions in the United States. Even though this lawsuit was ultimately unsuccessful in holding the FDA accountable for its reckless decisions, efforts to protect women and unborn babies from abortion drugs will continue.