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Winning on a technicality

The FDA evades accountability for its recklessness on abortion drugs, but the fight isn’t over

Pro-life protestors rally outside the Supreme Court building in Washington, D.C., on June 13. Associated Press/Photo by Mark Schiefelbein

Winning on a technicality
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Last Thursday, the Supreme Court refused to decide the legality of the FDA’s removal of longstanding safeguards on high-risk abortion drugs. The court instead ruled on a legal technicality, finding that the pro-life doctors in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine did not have standing to challenge the FDA’s actions. This means that the FDA’s deregulation of mifepristone remains unchecked, at least for now. But the Supreme Court in no way endorsed the FDA’s reckless removal of common-sense safeguards for women taking high-risk abortion drugs. The FDA may yet be held to account for putting politics above women’s health.

At issue in the case was the FDA’s removal of critical safety standards for the abortion drug mifepristone. When the FDA initially approved the drug in 2000 it required three in-person doctor’s visits and limited the gestational age to seven weeks. In 2016, it removed two of the three office visits, increased the gestational age to ten weeks, and took away the requirement that abortion providers report complications, except for deaths. Then, in 2021, it took away the final remaining in-person visit—the only opportunity for women to be screened for dangerous conditions like ectopic pregnancies—despite statistics showing that hospitalizations increase by over 300 percent with no in-person doctor visit. The Supreme Court didn’t weigh in on the validity of these actions. Instead, it ruled that the pro-life doctors in the case were not likely to be injured by the FDA’s removal of critical safeguards—even if the removal of those safeguards was unlawful.

Thankfully, three states stand ready to hold the FDA accountable for its recklessness in the lower court.

While the Supreme Court’s decision is disappointing, nothing in the decision changes the fact that the FDA’s own label says that roughly one in 25 women who take chemical abortion drugs will end up in the emergency room. Women and girls across the country have suffered severe, even life-threatening, complications because of the FDA’s unlawful actions. The FDA increased the already known risks when it stopped requiring doctors to provide vital in-person exams to women using these high-risk drugs. Today, it leaves women to take abortion drugs all alone in their homes or dorm rooms, without a doctor to let them know when emergency care is necessary. Women deserve better.

The government’s about-face explains why the Supreme Court parted ways with every other court to consider standing in this case.

Before the Supreme Court, the FDA went to great lengths to avoid review of its decisions, insisting instead that the pro-life doctors could not bring the case at all. This included the government flip-flopping on the issue of federal conscience protections. The government had initially told the federal courts that there was no evidence that federal conscience protections would protect doctors from being forced to participate in abortions in emergency situations. Yet at the Supreme Court, the FDA changed its position and said that federal conscience laws definitively protect doctors in these circumstances. The government’s about-face explains why the Supreme Court parted ways with every other court to consider standing in this case. And it resulted in the court recognizing that “[f]ederal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences.”

This is a win for pro-life medical professionals across the country. The Supreme Court based its standing decision on “the broad and comprehensive conscience protections guaranteed by federal law.” Because of these protections, the court held that pro-life doctors are fully protected from being complicit in abortion and thus were unable to show that the FDA’s removal of safeguards would cause them injury.

The FDA managed to avoid accountability for its reckless removal of safeguards on a legal technicality. Yet its actions are as wrong today as they were yesterday. And thankfully, the Supreme Court signaled that efforts to hold the FDA accountable can continue. This is not the FDA’s last day in court. Indeed, the case will continue in the district court with three states working to hold the FDA accountable for its actions.

Editor’s note: Erin Hawley represented the pro-life doctors in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine.

Erin Hawley

Erin Hawley is a wife, mom of three, senior counsel at Alliance Defending Freedom, and a law professor at Regent University School of Law.

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