FDA Escapes Accountability for Removing Abortion Drug Safeguards—for Now | Opinion

It’s June of a presidential election year in America, which means it’s hard to find a headline that isn’t focused on the candidates. Every so often, however, the Supreme Court will momentarily steal the spotlight with a ground-breaking decision, as it did on June 13 when it declined to address the FDA’s unlawful removal of its longstanding protections for women taking high-risk abortion drugs.

In U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, a group of pro-woman doctors and medical associations challenged the FDA for eliminating critical safeguards for women taking high-risk abortion drugs. In 2016, the FDA abandoned many of its original safety standards when it came to these drugs, including removing follow-up visits to check for serious complications like life-threatening infections and severe bleeding.

The FDA’s own documents say that roughly one in 25 women will go to the emergency room after taking the drugs. This is why it was astonishing when, in 2021, the FDA removed the requirement of an in-person doctor visit that ensured women do not have ectopic pregnancies or other life-threatening conditions before taking abortion drugs, allowing women to receive the drug by mail.

Some of the doctors concerned about this filed their issued its legal challenge against the FDA with the help of Alliance Defending Freedom, where I serve as senior counsel and was privileged to argue the case. Their case made it all the way to the Supreme Court, where the federal government and Danco Laboratories, the manufacturer of mifepristone, made several shocking admissions.

In its efforts to prevent the Supreme Court from reviewing its decision to remove longstanding safeguards protecting women’s health, the FDA insisted that federal conscience protections would allow pro-life doctors to opt out of participation in an elective abortion that ends the life of an unborn child. That was welcome news, especially because it was directly contrary to what the government had told other federal courts earlier this year when it insisted that federal conscience protections do not apply in emergency situations. This about-face explains why the Supreme Court parted ways with every other court to consider the case and held that “Federal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences.”

During a pointed exchange with Justice Samuel Alito during oral arguments, the abortion drug manufacturer also admitted that its primary interest in the case was its bottom line. When Justice Alito asked its attorney about the injury Danco would suffer if the FDA were to reapply its safeguards for women, her response was that “the injury is that we are prevented from selling our product.” This confirmed what should have been obvious all along: the abortion drug manufacturer is most concerned about selling as many drugs as possible, not promoting women’s health.

In another telling moment, the United States solicitor general told the Supreme Court that no one could challenge the FDA’s removal of common-sense protections on a high-risk drug that some 650,000 women take every year—not even the front-line doctors who routinely treat and care for women harmed by abortion drugs. This is a concerning view of administrative power—that an agency’s decision that arguably jeopardizes the health of hundreds of thousands of women is completely unreviewable. Fortunately, three states stand ready in the lower court to hold the FDA accountable for putting the health and safety of women and girls at risk.

No agency should be above the law, and that principle applies with special force to the FDA, the agency charged with protecting our health and well-being. The FDA managed to avoid accountability on a legal technicality, but its actions are as wrong today as they were before.

Erin Hawley is senior counsel and vice president of the Center for Life and Regulatory Practice with Alliance Defending Freedom (@ADFLegal). She argued before the U.S. Supreme Court in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine.

The views expressed in this article are the writer’s own.