Supreme Court to Rule on Whether Abortion Drug Safeguards Can Be Removed

By Dan Hart

On Wednesday, the U.S. Supreme Court announced that it would hear a case challenging a series of Food and Drug Administration decisions that removed safeguards governing the use of the abortion drug. Pro-life advocates and medical experts are hopeful for a victory, which they say will help protect women from significant health risks posed by the drug.

In 2000, the FDA controversially approved mifepristone for use in the U.S., a drug that starves an unborn child by blocking her from receiving the natural growth hormone progesterone, which eventually causes her death. At the time of its approval, several safeguards were put in place governing the dispensing of the drug due to the health risks it posed to women, including severe hemorrhaging, infections, and even death.

But in 2016, according to the Alliance Defending Freedom, the Obama administration’s FDA “extended the permissible gestational age of the baby for which a girl or woman may take chemical abortion drugs — from seven to 10 weeks’ gestation — removed two of three required office visits, allowed non-doctors to prescribe the drug regimen, and eliminated the requirement that providers report non-fatal adverse events to the FDA Adverse Event Reporting System.” Then in 2021, the Biden administration’s FDA rescinded a further restriction on the drug by allowing it to be distributed by mail.

In response, a group of medical associations and doctors represented by Alliance Defending Freedom (ADF) filed suit against the FDA earlier this year, noting that the reversals removed critical safeguards, including requiring doctors to assess the gestational age of the unborn child and determine whether or not it was an ectopic pregnancy before they could prescribe the drug.

In August, the Fifth Circuit Court of Appeals ruled in their favor, directing that the FDA must restore its original guardrails. The Biden administration promptly appealed the decision to the Supreme Court, which will hear the case in March of next year and will likely hand down a ruling in June.

On Thursday, Erik Baptist, a senior counsel at ADF, joined “Washington Watch” to discuss the details of the case.

“[The other side is] going to say that the FDA is essentially above the law and above reproach, that the FDA does not make any mistakes when it comes to drug regulation,” he explained. “And that’s simply false. We’ve seen that throughout the history of the FDA, but in particular in this case where it’s so egregious what they did, where they cut corners, disregarded women’s health, all in its zeal to push chemical abortion drugs across this country. … Can federal agencies such as the FDA be held accountable by the courts? The answer is emphatically ‘yes,’ and the Supreme Court has a long history of doing so.”

Baptist further highlighted a variety of adverse consequences as a result of the Obama and Biden administration’s decision to deregulate the abortion drug.

“The FDA removed [safeguards] and absolved the abortionist,” he pointed out. “Essentially, the abortionist now can push these drugs onto the women, then push them out the door. And then who’s going to have to clean up the mess and care for these women when they’re harmed? It’s our clients, the emergency room doctors across this country.”

Baptist continued, “[W]hat the Biden administration did most recently was authorized mail order abortion. Now, they say you don’t even have to meet with a prescriber or a doctor or any other medical professional before taking these drugs. Again, they induce labor and delivery. You would want to know if a woman has a life threatening ectopic pregnancy, if the gestational age of her baby is a lot farther along than she estimated, because that affects directly the health of the mother. The FDA disregarded that as well and wants to push these in all 50 states. That’s inherently dangerous. And if anybody wants to promote women’s health, they should want these safeguards coming back. … [T]hat’s what the FDA is disputing in front of the Supreme Court today. They don’t want women to have these pre-screening exams and these follow-up care visits. That’s simply egregious, dangerous, and immoral, frankly.”

Baptist went on to observe that because of the politics surrounding abortion, Democratic administrations spanning the last three decades have consistently ignored the health concerns that have dogged the abortion pill.

“[We’ve] seen that with every decision where they’ve cut corners, abused the law, and twisted it to try to get this drug approved and then took actions that failed to meet a scientific threshold that even the courts have questioned these days,” he argued. “… [A] lie that’s been told by the Biden administration, by the FDA and others that this is ‘safer than Tylenol’ — that is simply false, because the FDA’s own label says upwards of 5% of women will end up in the emergency room if they take chemical abortion drugs. You don’t see that on the Tylenol label. Five percent of people who take Tylenol do not end up in the emergency room. So that is simply a false statement, and it’s misleading women into taking this dangerous drug unsupervised, unmanaged, in their own homes, in their dorm rooms. And that’s why they’re presenting themselves to America’s emergency rooms today.”

Baptist concluded by expressing hope that the Supreme Court will “restore commonsense safeguards … to make sure [women are] cared for throughout the process. Because this is not just a one-day process. It’s not even just a two-week process. FDA says it can do upwards of 30 days [that] you can be experiencing pain and complications from these drugs. So it’s something that women in this country deserve, and FDA has not given women what they deserve.”

Editor’s note: Dan Hart writes for the Family Research Council. He is the senior editor of The Washington Stand.