The Supreme Court, in an interim “emergency” decision requested by the Biden administration, on Friday rejected lower court rulings that placed safety restrictions on the abortion pill mifepristone.
Ironically, only last week, a reminder of the need for drug certification rules was provided in a settlement: Danco Industries, the manufacturer of mifepristone, had to pay $765,000 to the U.S. because from 2011 to 2019, the company failed both to properly label imports of the drug (its single product) as originating in China and to pay customs duties on those imports.
It’s timely that an old scandal concerning the inadequacy of the safety research on the abortion drug has resurfaced.
To this day, there remain significant gaps in the research. Seriously comprehensive research should have been done before the Food and Drug Administration, intimidated by massive political and media pressure, issued a premature approval letter back in September 2000.
Significant safety problems with mifepristone were exposed in two lower courts. An order was issued by District Judge Matthew Kacsmaryk to halt the approval of mifepristone, and a 5th U.S. Circuit Court of Appeals decision then allowed the FDA’s certification of the drug to stand but limited its use.
No more hiding
The time has come for the FDA to face up to the scandal attached to its reluctant, politically coerced approval of mifepristone.
Few today can recall that scandal, but Kacsmaryk, in his April 7 order, drew a clear outline of the shameful history.
Nevertheless, the 5th Circuit Court of Appeals decided that the abortion drug should remain available pending a full hearing of the case, but retained limited access to the first seven weeks of pregnancy, down from 10. The appeals court also decreed that in-person visits would once again be necessary to obtain the pill and blocked the medication from being sent by mail.
Should mifepristone have been approved by the FDA?
Yes: 24% (4 Votes)
No: 76% (13 Votes)
Now, the Supreme Court, at the behest of the Department of Justice and Danco, has temporarily restored complete access. Investigation in the lower courts will still go ahead, but it should have been done 23 years ago.
There can be no hiding that historical scandal now. Eventually, it will reach the Supreme Court again. The truth will be uncovered, and it’s not pretty.
Anatomy of a scandal
Back in 2000, the FDA was manipulated into abandoning the thoroughness of its standard safety investigation regimen.
It adopted instead the accelerated approval process for emergency medications that had been introduced in the ’90s to fast-track new experimental drugs to deal with, inter alia, the alarming HIV/AIDS outbreak. The sponsors of the abortion pill, the Population Council and Danco, opportunistically jumped on the expedited bandwagon.
The FDA, under political and media pressure, reneged on its duty and claimed an emergency need for this drug to be approved. It placed healthy pregnancies in the same basket as the AIDS epidemic. The usual careful regimen was rashly tossed aside in this newly instituted process.
Now let’s take a look at some of the anomalies.
1. In 1996, the Population Council filed a new drug application for mifepristone with the FDA. The real result, after four years of review following the proper protocols, was a thumbs-down — the drug could not be declared safe.
A letter to the Population Council dated February 2000 stated that “adequate information has not been presented to demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended.”
2. On June 1, 2000, the FDA sent another letter to the Population Council setting out proposed restrictions to address serious safety issues.
Doctors were to be trained in administering mifepristone and treating adverse events and must have “continuing access (e.g., admitting privileges) to a medical facility equipped for instrumental pregnancy termination, resuscitation procedures, and blood transfusion at the facility or [one hour’s] drive from the treatment facility.”
3. “When FDA’s proposal was leaked to the press, a political and editorial backlash ensued.” — Kacsmaryk
4. “In response, the Population Council rejected the proposal and repudiated the restrictions the sponsor itself proposed in 1996 — what FDA deemed a ‘very significant change’ in the sponsor’s position. Because ‘[t]he whole idea of mifepristone was to increase access,’ abortion advocates argued that restrictions on mifepristone ‘would effectively eliminate’ the drug’s ‘main advantage’ and would ‘kill[] the drug.’” — Kacsmaryk
5. Only a few months later, the FDA reneged on its safety proposals and gave in to the objections of the Population Council and Danco. Despite its “serious reservations” about mifepristone’s safety, the FDA concluded that “there was no need for special certification programs or additional restrictions.”
6. In September 2000, the FDA’s assessment from earlier that year was abandoned — replaced with a set of precautions that waived the requirement for an assessment of the safety of mifepristone in pediatric patients.
7. Sixteen years later, the safety precautions adopted in lieu of the “adequate information” originally demanded by the FDA were further relaxed.
8. In 2021, precautions were so relaxed that mifepristone could be sent through the mail to be self-administered.
With the unreported and under-reported, research studies were skewed.
Back in 2006, the U.S. House Subcommittee on Criminal Justice, Drug Policy and Human Resources held a hearing to investigate the FDA’s handling of mifepristone and its subsequent monitoring of the drug.
Kacsmaryk quotes a subcommittee report showing that mifepristone was “associated with the deaths of at least 8 women, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection” and that there were “more than 950 adverse event cases” associated with mifepristone “out of only 575,000 prescriptions, at most.”
Kacsmaryk points out that the FDA’s 2016 relaxation of nearly all safety precautions relied on the very conditions FDA is now refusing to adopt.
“Moreover, FDA shirked any responsibility for the consequences of its actions by eliminating any requirement that non-fatal adverse events be reported. Thus, FDA took its chemical abortion regimen — which had already culminated in thousands of adverse events suffered by women and girls — and removed what little restrictions protected these women and girls, systematically ensuring that almost all new adverse events would go unreported or underreported.”
The 5th Circuit Court of Appeals underlined this point, saying that the FDA eliminated REMS (risk evaluation and mitigation strategies) safeguards based on studies that included those very safeguards. “The fact that mifepristone might be safe when used with the 2000 Approval’s REMS (a question studied by FDA) says nothing about whether FDA can eliminate those REMS (a question not studied by FDA).”
The court is scathing: “This ostrich’s-head-in-the-sand approach is deeply troubling — especially on a record that, according to applicants’ own documents, necessitates a REMS program, a ‘Patient Agreement Form’ and a ‘Black Box’ warning.” The patient agreement form requires the signer to have a surgical abortion if the pill fails.
“In sum, applicants’ own documents — from the ‘Patient Agreement Form’ to the ‘Black Box’ warning that have accompanied mifepristone ever since the 2000 Approval up to and including today — prove that emergency room care is statistically certain in hundreds of thousands of cases.”
There is a real scandal in the fact that the FDA has ignored the genuine danger that, without the original requirements, some users will not be able to confirm pregnancy and gestational age, to recognize ectopic pregnancies, or to identify coerced abortions, particularly in cases of abuse or human trafficking.
Finally, we must never forget that behind all Big Pharma is the unquenchable thirst for big money. But that must await another time.
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