(The Daily Signal) Liberals are predictably apoplectic about a recent case that makes a first-of-its-kind claim: that the U.S. Food and Drug Administration never had the authority to approve the chemical abortion pill mifepristone when it did so in 2000.
In the lawsuit, the plaintiffs—a coalition of national medical associations and doctors experienced in caring for pregnant and post-abortive women—have requested that the court find the FDA’s approval of the pill and its years of subsequent loosening of restrictions on its use to be unlawful. They have requested that the court order the FDA to withdraw its approval of the drug.
That outcome would have an unprecedented impact on the availability of the drugs that are part of the FDA’s two-drug regimen for chemical abortion: mifepristone and misoprostol. Those drugs are responsible for nearly 50% of American abortions annually and represent the most common way to terminate unborn life in the U.S.
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The FDA’s stated mission is to protect the public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. But the plaintiffs in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration argue that the agency ignored that mission in pushing mifepristone through its accelerated approval process and ignoring the relevant law and science governing chemical abortions.
Because FDA regulations on accelerated approval of drugs require that “new drugs [be] studied for their safety and effectiveness in treating serious or life-threatening illness and … provide meaningful therapeutic benefit to patients over existing treatments,” the FDA would have had to classify pregnancy as an “illness.” And not just an “illness,” but a “serious or life-threatening” one at that.
This, plaintiffs argue, would be in addition to a showing that chemical abortion pills provide a “meaningful therapeutic benefit.”
Abortion as a “therapeutic benefit” to treat the “serious illness” of pregnancy doesn’t pass the straight-face test.
The Administrative Procedure Act governs the process by which federal agencies develop and issue regulations and take formal action. If a federal agency’s action is found to be arbitrary, capricious, or an abuse of discretion, a judge may nullify that action. The plaintiffs seek this result because, they argue, the FDA’s findings on mifepristone are at odds with the clear letter of its regulations on accelerated approvals.
The plaintiffs also argue that the FDA never appropriately studied the safety of the drugs under their “labeled conditions of use” despite being required to do so by the Federal Food, Drug, and Cosmetic Act. The plaintiff doctors argue that among other things, the FDA didn’t follow testing protocols, including making sure that the trials were blinded, randomized, and controlled.
Finally, the plaintiffs claim that the FDA ignored the potential hormonal impacts of the drugs on adolescent girls in violation of the Pediatric Research and Equity Act. That law requires pediatric studies to be performed for certain drugs and biological products with the goal of obtaining pediatric labeling for the product that sufficiently warns of any related harms.
Here, the doctors argue, not only did the FDA ignore substantial evidence that chemical abortion drugs cause even more complications than surgical abortions, but it waived the pediatric study requirement without any explanation whatsoever. This claim is particularly poignant, as tragic news broke recently that a 19-year-old died of septic shock after taking the FDA-approved abortion pill regimen.
According to Alliance Defending Freedom, the law firm representing the plaintiffs, the suit is the culmination of decades-long efforts by their clients to hold the FDA accountable for its actions on abortion drugs. In 2002, some of them filed a citizen petition with the FDA arguing that the mifepristone approval exceeded the agency’s authority and offering scientific reasons to withdraw its approval.
The FDA sat on the petition for 14 years, ultimately rejecting it in 2016. But on the same day it rejected the petition, it expanded mifepristone’s approved use from seven weeks to the first 10 weeks of pregnancy.
Since 2016, the agency has continued to loosen abortion drug restrictions—efforts that reached their zenith during the COVID-19 pandemic—when it allowed doctors to prescribe the drugs by telemedicine rather than in-patient visits.
And earlier this year, for the first time, the FDA allowed retail pharmacies to dispense mifepristone if they got certified with the federal government, effectively turning neighborhood CVS or Walgreens stores into abortion clinics.
“Abortion rights” advocates and the Biden administration have grown increasingly concerned that the case is likely to be decided entirely by conservative textualist judges who will interpret the law as written, which could lead to restricted abortion access even in Democrat-led states.
If it loses in the trial court, the Biden administration would have to appeal to the U.S. Court of Appeals for the 5th Circuit in New Orleans, where its arguments might not fare well.
A decision on the case is expected as early as this week.
Editor's note: This article was originally published by The Daily Signal, the Heritage Foundation's news platform.
