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A government agency above the law?

Abortion drug safeguards finally had their day in court

Pro-abortion activists rally outside the Supreme Court in Washington, D.C., on March 26. Associated Press/Photo by Jose Luis Magana

A government agency above the law?
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Earlier this week, the pro-life medical organizations that have long challenged the Food and Drug Administration’s approval and removal of abortion drug safeguards finally had their day in court. The Supreme Court heard oral argument in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, the case challenging the FDA’s removal of longstanding safeguards on high-risk abortion drugs.

It was a long time coming. The FDA has continually removed protections for the drug. In 2016, the agency increased the approved gestational limit from seven to 10 weeks and removed the follow-up visits to check for life-threatening complications like severe bleeding and infection, even though the drug label acknowledges that the need for surgical intervention steadily increases with gestational age. In 2021, the FDA removed the last remaining in-person visit and the only opportunity to physically screen for dangerous conditions like ectopic pregnancies and to accurately assess gestational age. The agency did so even though the studies it relied on acknowledged that the need for emergency and other medical care would likely increase without an in-person visit. In fact, the FDA conceded that its studies were “not adequate” to determine that abortion drugs were safe when dispensed through the mail.

The FDA now permits abortion providers to mail drugs to women and girls to take alone at home or in their dorm room without ever seeing a healthcare provider in person. An amicus brief details what this looks like in practice: A woman was told by Planned Parenthood to drive across state lines to a McDonald’s parking lot to call a telehealth provider, who directed her to pick up abortion drugs from a FedEx drop box.

In short, the FDA has shown a callous disregard for women’s health (not to mention unborn life) by ending the safety standards it once provided to women using abortion drugs. Indeed, the FDA has continually downplayed the drug’s risks. It told the lower courts that the abortion drug was as safe as Advil. That’s reckless. The FDA’s own label recognizes that abortion drugs are high-risk, warning that roughly 1 in 25 women will end up in the emergency room after taking them, and that up to 7 percent of women will need surgery. One in 25 people who take Advil don’t end up in the emergency room. In fact, according to the FDA and the abortion industry’s own data, a woman who takes abortion drugs is millions of times more likely to end up in the emergency room than someone who takes Advil. That’s not a typo.

The FDA’s contention that its actions are above the law should be a nonstarter.

Before the Supreme Court on Tuesday, the FDA went to great lengths to avoid review of the merits of its decisions, insisting instead that the pro-life doctors could not bring the case at all.

In a major concession for pro-life healthcare providers everywhere, the government conceded that federal conscience protections prohibited healthcare providers in emergency situations from being coerced into participating in abortions. This was directly contrary to what the government had previously told other federal courts.

The FDA then told the court that it didn’t matter whether doctors in the operating room might not have time to raise a conscience objection and find a doctor comfortable completing an abortion because no one could challenge the FDA’s actions in court. That’s a scary proposition. No agency is above the law. And yet the FDA argued that regardless of how unlawful the agency’s actions were, it was beyond the reach of the federal courts.

In another revealing exchange, the company that manufactures the abortion drug admitted that its interest in the case was purely monetary. The drug company was not interested in, as the media likes to put it, promoting women’s health, but in selling as many abortion drugs as possible. Indeed, the drug company sells one dose of the drug for just under $100 (and Planned Parenthood and other abortion providers mark it up to around $500 a dose).

While the Supreme Court seemed uncertain whether the pro-life doctors and medical associations had standing, the FDA’s contention that its actions are above the law should be a non-starter. This would cede extraordinary power to the federal agency put in charge of protecting Americans’ health and safety. It would mean that the only entity with a say in a drug approval process is the profit-motivated drug manufacturer. We hope and pray that the court disagrees with the FDA and instead holds the agency accountable for its harmful decisions.

—The author represents the 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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