Since a group of pro-life plaintiffs first challenged the Food and Drug Administration’s approval of mifepristone, one of the two drugs used in chemical or medication abortions, the reporting on the case has been predictable.
Most of the news coverage of the legal threat to the “long-approved abortion pill” have focused only on the conservative credentials of the federal judge in Amarillo overseeing the case.
Very few have tried to explain the nature of the legal challenge, its merits and the health implications for women across the United States — which are significant.
Perhaps that’s because to our modern political sensibilities abortion is easiest to explain as a morality play.
But the current case, the Alliance for Hippocratic Medicine v. FDA, doesn’t fit this narrative.
It doesn’t contemplate the typical existential questions abortion raises or even ponder the ethics of its practice.
It is instead, an infinitely complex, deeply technical squabble over administrative law, and — as the plaintiff’s take painstaking care to describe — the FDA’s decision to effectively ignore its own regulations for purely political reasons, much to the detriment of women.
The 100-plus-page complaint, brought by the Alliance for Hippocratic Medicine, four other pro-life medical organizations and four individual doctors (represented by the Alliance Defending Freedom), details a more than 20-year history of what the plaintiffs contend is the FDA’s failure to protect women and girls from abortion drugs that some studies have shown can be dangerous.
This failure begins, they assert, with the FDA’s initial approval of mifepristone in 2000. The FDA did it by way of an accelerated drug approval authority, called subpart H. That regulatory authority is reserved for drugs that treat serious or “life-threatening illnesses and provide a meaningful therapeutic benefit to patients over existing treatment.”
It’s a very specific authority and rarely used.
Indeed, as the court noted during oral argument, before mifepristone was approved in 2000, the FDA had completed only 37 accelerated approvals.
Most of those treatments were for HIV. Several were for cancer. There was even one for leprosy.
How exactly the FDA determined that pregnancy — a natural physiological state experienced by many women — qualified as such an “illness” is a question worth asking.
The answer, though, is probably no more complicated than political pressure. After taking office in 1993, President Bill Clinton made approving the abortion pill a particular priority.
The FDA, of course, obliged, approving the drug conditionally in 1996 and fully in September 2000, when it became available for doctors to prescribe under certain conditions.
But as the complaint describes, in addition to the FDA’s misuse of subpart H, the drug’s approval violated the Federal Food, Drug, and Cosmetic Act because the agency did not study the drug’s safety under the labeled conditions. For example, it did not require an ultrasound to accurately date the pregnancy and rule out the possibility of ectopic pregnancy, even though ultrasounds were used in the studies upon which the FDA’s approval relied.
These regulatory violations did not go unnoticed, and in 2002, several medical organizations (including some of the plaintiffs) filed a citizen petition asking the FDA to remove its approval of mifepristone. They cited multiple studies that found a high rate of severe complications from the drug’s use, much higher than surgical abortion. They included excessive bleeding and incomplete abortion that endangered women and forced many to seek emergency medical care.
The agency responded by sitting on the petition for almost 14 years, finally rejecting it in 2016. At the same time, the FDA made major changes to the established safeguards for mifepristone’s use.
This included changes to the dosage and route of administration for the chemical abortion drugs; a reduction in the number of required in-person office visits from three to one; and an expansion of who could prescribe and administer chemical abortion drugs beyond medical doctors.
The FDA also extended the gestational age for which the drug could be prescribed from seven to 10 weeks, even though studies showed that the chance of complications increased along with the duration of the pregnancy.
In perhaps one of the most worrying decisions by the FDA yet, it eliminated the requirement that medical providers report adverse events — with the exception of death.
This all but ensured that complications and emergencies from mifepristone’s use would remain unknown to its prescribers and potential users. It also failed to satisfy the rigorous scientific standard to which the FDA is held by the public and the law.
But the horse had long ago left the stable, so, as the plaintiffs contend, the FDA continued to exceed its authority, approving the generic drug in 2019 without requiring any new clinical investigations or studies.
In 2021, the agency allowed the drugs to be prescribed via telemedicine (eliminating even the one-visit requirement) and delivered by mail, opening up the FDA to violating another federal law, the century-old Comstock Act.
While those changes were initially made in response to the COVID-19 pandemic, the Biden administration (perhaps in anticipation of the Supreme Court decision reverting abortion law to the states) quickly made them permanent.
Later that year, the FDA rejected a second citizen petition from the plaintiff’s which had sought to restore and strengthen the pre-2016 drug regimen, leaving the plaintiff’s few remedies other than to file suit.
While the facts of the case would leave anyone breathless with their complexity, you need not be a pro-life ideologue to find the merits compelling.
Yet most observers choose instead to focus on the low-hanging fruit — the conservative judge who will decide mifepristone’s fate.
As is frequently noted, Judge Matthew Kacsmaryk most recently worked at the First Liberty Institute, a Texas-based organization focused on defending religious freedom (including, contrary to popular belief, the religious freedoms of non-Christians). He has the perhaps unfortunate distinction of being an appointee of President Donald Trump.
His affiliation with a Texas crisis pregnancy and adoption organization, motivated by his own sister’s experience with unplanned pregnancy and adoption, is also frequently mentioned.
Seldom is it noted that Kacsmaryk’s robust legal experience also includes a stint in private practice (where he defended pharmaceutical companies, among other clients), and five years as a federal prosecutor at the U.S. Attorney’s Office in Dallas-Fort Worth.
Indeed, during his tenure at the Justice Department, Kacsmaryk earned accolades from none other than Attorney General Eric Holder, the Obama lieutenant who presented Kacsmaryk a 2013 award for national security work.
During this time, Senior Judge Terry R. Means of the Northern District of Texas came to appreciate Kacsmaryk’s careful writing and meticulous legal reasoning.
“I suspect that many who criticize him for his rulings haven’t actually read his opinions,” Means said. “One may legitimately disagree with his findings of fact and even his conclusions on the law, but I do not believe that they can honestly say that they are unfounded, unreasonable, frivolous, or arbitrary.”
Kacsmaryk’s ruling, which is expected any day, could range from ordering the FDA to take mifepristone off the market (at least while the case is further litigated), to compelling the agency to begin an administrative process called withdrawal. That means the FDA, of its own accord, would remove from the market the drug on the basis that it is not shown to be safe under the conditions used, prescribed, recommended or suggested in the labeling.
He could also reject the plaintiff’s claims. Expect the ruling, like the case itself, to be complex.
There has been widespread criticism that the plaintiff’s in this case went “judge-shopping,” a common practice of attorneys across the ideological spectrum.
As Josh Blackman, a professor at South Texas College of Law Houston, explained to the Texas Tribune, “lawyers have a duty to file a case in a district that best serves [their] client.”
Still, there isn’t any reason for the defendants — or the plaintiffs — to believe that Kacsmaryk’s personal beliefs or professional past will have any bearing on his decision in this, or any, case.
“Judge Kacsmaryk is not an ideologue,” Means said. “Nor does he know in advance of his consideration of a case how he wants to decide it.”
We have good reason to believe that. In the case of the “long-approved” abortion pill, for all of its 20-year, mind-numbing complexity, the facts speak for themselves.
The real question is, are people listening?
