Setting the Record Straight on the FDA Case at the Supreme Court

F ederal agencies must be held accountable. They are not above the law. Yet the U.S. Food and Drug Administration seeks to avoid accountability in the Supreme Court case challenging its reckless decisions to remove long-standing safeguards for women who use abortion drugs — requirements that once ensured women received basic in-person doctor visits.

The organization I lead — Alliance Defending Freedom — represents the medical associations and doctors in that case who are challenging the FDA’s removal of those safeguards. The most shocking revelation at oral argument on March 26 was the FDA’s insistence that no one has legal standing to challenge its actions as unlawful — not even women harmed by those FDA actions. That should alarm everyone concerned about the safety of our nation’s drugs and the seemingly unchecked power of the administrative state.

The FDA insists that these abortion drugs are safe, and that our doctors are not affected by its actions. But the agency admits that roughly one in 25 women who use these drugs will go to emergency rooms — an outcome that the FDA itself calls a “serious adverse reaction.” And the agency openly concedes that doctors in emergency rooms — where our clients work — are critical to dealing with abortion-drug complications. Because more than 640,000 chemical abortions now occur annually, the FDA’s own data indicate that abortion drugs are sending tens of thousands of women to the emergency room each year.

That’s not all. The FDA cited studies in 2021 indicating that the removal of the initial in-person visit would increase trips to the emergency room. And the agency also cited a study indicating that hospitalizations would rise threefold.

It takes real chutzpah for an agency to design a plan that relies on emergency-room doctors to fill the gap created by withdrawn safeguards and then deny that those doctors are affected when they seek legal recourse.

Does anyone (except the pharmaceutical industry) want to insulate the FDA from judicial review? This is the same agency that approved opioid use for chronic pain because it said the risk of addiction was rare. Opioid litigation over the past decade has proven that view to be profoundly wrong. Tell the tens of thousands of Americans who die from opioid overdose each year that this agency should be free from oversight.

Some critics of our lawsuit say that we did not identify any doctors tangibly affected by the FDA’s changes. That’s nonsense. Three of our doctors have each had to treat women suffering from abortion-drug complications more than a dozen times.

Other naysayers doubt our doctors’ conscience claims. They are sorely mistaken. Our doctors are all pro-life. Some object only to engaging in the physical act that ends an unborn baby’s life, but others object to participating in an elective chemical-abortion process through the gruesome procedure of removing retained baby parts and tissue even after the baby has died. The Supreme Court has long recognized these kinds of complicity-based conscience harms. It should do the same in this case.

The FDA conceded at oral argument that federal law protects our doctors’ consciences. But just months before we filed this case, the government said the opposite: It said federal law does not require hospitals “to accommodate an objecting employee.” The FDA’s eleventh-hour about-face doesn’t cast shade on our lawsuit. It smacks of self-serving gamesmanship.

More important: It is not practicable for our doctors to invoke any conscience protection that might exist. Our doctors are frequently called into emergency situations. When they encounter a profusely bleeding woman with retained baby parts, the exigencies force our doctors, who care deeply for all of their patients, to help the woman and violate their conscience, regardless of what federal law says. They don’t have time to opt out. The FDA’s irresponsibility shouldn’t force doctors to choose between their conscience and their patients’ well-being when restoring an initial in-person visit would reduce the number of women suffering severe complications.

Courts have allowed environmentalists who want to view animals to sue over land-improvement projects. Religious employers likewise have standing to challenge a requirement to sign forms that excuse them from providing insurance coverage for abortion. It naturally follows that doctors who entered their professions for the joy of bringing life into the world should also be allowed to sue when the FDA’s actions force them into the emotional turmoil of participating in the grisly chemical-abortion process and watching women suffer from abortion complications.

It’s no surprise that the FDA wants to keep the court from reviewing its actions. They’re egregious. Federal law requires the agency to point to “adequate tests” or other sufficient proof of safety. But in 2021, the FDA removed the initial in-person visit based on studies that it said were “not adequate” and reporting data that it elsewhere recognized were unreliable (just years after eliminating the requirement that abortion facilities report all serious adverse events). A court doesn’t need to second-guess the FDA’s expertise to invalidate this action. It need only look at the agency’s own words.

Another false narrative is that a Supreme Court ruling for our doctors would prevent women from accessing abortion drugs. Not so. A ruling for us would simply reinstate the safety standards under which millions of women took these drugs for more than 15 years. Abortion drugs would be no more difficult to access than they were under the Obama administration. As recently as 2020, the FDA said that the initial in-person visit was only “minimally burdensome” to women. Isn’t restoring these modest safety standards better than leaving girls to induce labor alone in their dorm rooms? Shouldn’t we do away with these new back-alley abortions?

Some have criticized our lawsuit for seeking a nationwide pause that restores commonsense safeguards such as in-person doctor visits. Though nationwide injunctions are often inappropriate, no one disputes that a court may give broad relief if necessary to solve the harms before it. That’s the case here. Our associations’ thousands of member doctors are located throughout the country, and our doctors are asserting the interests of the women they treat — many of whom travel across state lines — to vindicate the harm they’ve experienced. The only way to protect all these interests is to stop the FDA from carrying out its reckless actions.

For years, the FDA has considered doctors in emergency rooms to be the backstop for women harmed by these drugs. Now that the agency must answer for what it has done, it is singing a different tune. Yet the FDA can’t rely on our doctors to fill the gaps it caused and then deny that they’re affected. The court should see through this ruse and hold the FDA accountable.

Editor’s note: This article has been updated since its original publication.