FDA Abortion Pill Stance Endangers Patients, Undermines Doctors

On March 26, Alliance Defending Freedom Senior Counsel Erin Hawley argued before the US Supreme Court on behalf of doctors and medical associations. These medical professionals have witnessed firsthand the harms caused by abortion drugs since the Food and Drug Administration recklessly removed nearly every safeguard it originally deemed necessary for use of chemical abortion drugs.

These controls included in-person office visits to check for ectopic pregnancies, severe bleeding, and life-threatening infections. The FDA’s removal of common-sense, basic safety standards has made taking abortion drugs less safe. And the agency acknowledged from the beginning that gynecologists and emergency room doctors like the ones we represent in this case will handle the fallout.

Yet during the Supreme Court oral arguments, the federal government questioned the right of these doctors to challenge the FDA’s unlawful actions, and went so far as to say no one has the right to question what the agency did.

According to the government, the FDA’s decision to remove safeguards from these high-risk drugs is untouchable and above the law. Apparently Americans can’t challenge the agency responsible for the health and safety of our food and drugs—even if it breaks the law and harms tens of thousands of people in the process.

When removing safeguards for high-risk abortion drugs, the FDA violated federal law and its duty to keep patients safe. We must be able to file lawsuits when the government has engaged in practices that put so many people at risk.

In this case, patients are suffering the consequences. The FDA’s own label for mifepristone says roughly one in 25 women who take it will end up in the emergency room and up to 7% will require surgery. Americans shouldn’t let the FDA fool them into thinking this is as safe as taking ibuprofen (something it irresponsibly told the lower courts).

On the contrary, these are high-risk drugs, and we should all agree that people deserve ongoing care from in-person doctors when taking them—safeguards the FDA said in 2020 were “necessary” and “minimally burdensome.”

Yet now the FDA’s actions have pushed patients to receive these drugs in the mail or take them in their dorm room alone without being checked by a doctor for life-threatening conditions. As evidenced again before the Supreme Court, the FDA continues to show callous disregard for women’s health.

It’s particularly appalling that the FDA based its decision to remove the last remaining in-person visit on studies it acknowledged were “not adequate, ” even though federal law that governs the FDA requires the agency have “adequate tests” or other information supporting its actions.

It’s a textbook violation of the law. In trying to insulate its actions from legal review, the FDA ignores that the doctors we represent are directly affected and the most obvious candidates to challenge what the agency did.

The FDA has spent years saying a significant number of patients who take these abortion drugs will need to go to emergency rooms. Our clients are the very doctors who are called upon to treat them. It takes a lot of nerve to design a flawed and dangerous scheme that depends on doctors in emergency rooms and deny those doctors’ interests when they come to court.

The Supreme Court should see past this ruse, declare the FDA isn’t above the law, and hold the agency accountable for its reckless actions. Americans should be deeply concerned by what the FDA has done.

Regardless of one’s views on abortion, women’s health shouldn’t come second to pharmaceutical profits. Yet as we heard during the oral arguments, Danco Laboratories—the manufacturer of mifepristone—conceded that making money from women taking abortion drugs is its primary interest in this case.

We urge the Supreme Court to hold the FDA accountable to do its job and reinstate the necessary abortion drug safeguards. All Americans deserve a federal government that looks out for their health and well-being.

The case is FDA v. Alliance for Hippocratic Medicine, U.S., No. 23-235, oral argument 3/26/24.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

Author Information

Kristen Waggoner is CEO, president, and general counsel of Alliance Defending Freedom.

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