Texas abortion pill case does not constitute a morality play. It’s a complex, technical squabble
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 The case is being handled in Amarillo.
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.
The current case is 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 plus-100-page version 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. It was done by an FDA investigator. 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, the court found this out during oral argumentThe FDA had only completed 37 accelerated approvals before the approval of mifepristone in 2000.
Many of these treatments were for HIV. There were many for cancer. One even had 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.
But the answer is probably not more complicated than political pressure. President Bill Clinton took office in 1993. approving the abortion pill A particular priority.
Of course, the FDA obliged. It approved the drug conditionally in 1996, and then fully in September 2000. 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.
FDA PETITION TO REVIEW
These regulatory violations were not overlooked. In 2002, several medical organizations, including some of the plaintiffs, filed a citizen petition to the FDA asking it to revoke 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. These included severe bleeding and an incomplete abortion, which could have dangerous consequences for women. Many were forced to seek emergency medical attention.
The FDA responded by sitting on this petition for nearly 14 years and finally rejecting it in 2016. At the same time, the FDA made major changes to the established safeguards for mifepristone’s use.
These included changes in the route and dosage of the chemical abortion drug; a decrease in the number required in-person visits from three to one; as well as an expansion of the list of people who can prescribe and administer chemical abortion drugs to include other doctors.
Even though the FDA increased the gestational age at which drugs could be prescribed from 7 to 10 weeks, studies have shown that complications are more likely with longer periods.
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 meet the strict scientific standards that the FDA holds it to.
The horse had left the stable long ago, so the FDA did not need to conduct any clinical studies or new clinical investigations in order to approve the generic drug in 2019.
The FDA was allowed to prescribe drugs via telemedicine by 2021. This eliminated the requirement for a one-visit visit and allowed them to be delivered by mail. This opens up FDA to violations of another federal law (the century-old). Comstock Act.
Although these changes were originally made to combat the COVID-19 pandemic in 2001, they were quickly made permanent by the Biden administration in anticipation of the Supreme Court decision that would reverse abortion law to states.
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.
A TRUMP-APPOINTED JOINT JUDGE
The facts of this case are so complex that it would make anyone’s stomach turn, but you don’t have to be a prolifer to find their merits compelling.
Yet most observers choose instead to focus on the low-hanging fruit — the conservative judge who will decide mifepristone’s fate.
Judge Matthew Kacsmaryk, who is often mentioned, was most recently employed at the First Liberty Institute in Texas. This Texas-based organization focuses on religious freedom. He is an appointee for President Donald Trump, which is a shame.
His association 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.
Kacsmaryk was indeed a Justice Department employee during his tenure. earned accolades Eric Holder, Obama lieutenant, was the one who presented Kacsmaryk an award for 2013 for his 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. The FDA could then withdraw the drug from its own initiative. It is being removed from the marketplace because it isn’t safe in accordance with the conditions prescribed, recommended, or suggested on the label.
He could also reject the plaintiff’s claims. The ruling could be complicated, just like the case.
There has been widespread criticism that the plaintiff’s in this case went “judge-shopping,” a common practice of attorneys across the ideological spectrum.
Josh Blackman, South Texas College of Law Houston’s professor, said: 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.”
There are good reasons to believe this. 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 here is, are people really listening?