The abortion drug Mifepristone (Mifeprex) entered the US market in 2000 after the FDA approved the drug. For the past two decades, the drug’s official labeling stated some permutation of the following:
“Mifeprex…Administration must be under the supervision of a qualified physician”
“Mifeprex may be administered only in a clinic, medical office, or hospital, by or under the supervision of a physician, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies.”
Other prominent medical websites such as the Mayo Clinic state: “This medicine is given only by your doctor. You will not be allowed to take it at home. [It] requires three visits to your doctor.” Other websites including the Federal Government’s NIH’s National Library of Medicine website state the many safety issues regarding mifepristone along with “Mifepristone is only available in clinics, medical offices, and hospitals” and “You can only take mifepristone in your doctor’s office or clinic.”
The FDA is now not just approving — but promoting — Big Pharma’s proposal to permit mailed, at home use of mifepristone for “do-it-yourself” abortion. No more doctor or staff present. No more ultrasounds to confirm gestational age or any in-house monitoring for complications for internal bleeding — for a drug well known to cause life-threatening bleeding.
The FDA has chosen to completely ignore the reports of thousands of women who are transported to emergency rooms due to heavy bleeding, retained tissue, infection, or other complications as a result of mifepristone abortions. Even then, 24 of these women still died, and another 500 would have died if they had not reached emergency medical care in time.
What recently changed? Did the FDA just discover that mifepristone is safer than originally thought? Has a major new prospective, purpose-designed safety study been confirmed underlying the FDA decision? The answer is no. Mifepristone for chemical abortion is still very hazardous.
Long History of Hazard Ignored by the FDA
Mifepristone was recognized as so unsafe that for decades it could only be dispensed under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) protocol. REMS protocols are only issued to unusually high-risk drugs, which means that mifepristone is one of the rarely selected FDA-approved drugs that although approved, has explicit “serious safety concerns.”
The FDA did release a medical review showing its justification for allowing “at home” use of its abortion drugs, but anyone looking for scientifically sanctified reasoning based on historical and current safety findings will be both disappointed and outraged. What they will see are many small, non-safety studies from places like the journal Contraception, along with the recurrent authorship of pro-abortion academics and study sponsorship from places like the National Abortion Federation and the biased UCSF Bixby Center for Global Reproductive Health.
The few studies that concluded adequate safety were not prospectively, statistically, or appropriately designed safety-centric studies. Numerous references in the FDA’s medical review did not measure safety at all despite mifepristone currently being a REMS product. Those FDA studies that referenced safety often required ultrasounds in assessing gestational age and bleeding risks, which would no longer be conducted for mailed mifepristone use.
Most importantly, referenced FDA study participants were closely monitored by clinical study personnel and almost always in person; not simply mailing out drugs and leaving patients at home by themselves. Several studies referenced by the FDA deceptively avoided mentioning “safety” and instead used murky, academically unacceptable substitute wording such as “unplanned clinical encounters.”
Importantly, the one study the FDA referenced that emphasized safety and had a noteworthy number of participants required in-patient visits and actually concluded increased hospital visits with mifepristone use, but the FDA didn’t address that finding in its review.
The preposterous, non-clinical and irrelevant conclusions of some studies that the FDA used to justify its decision included: “Medication abortion with mail-order pharmacy dispensing of mifepristone appears effective, feasible, and acceptable to patients.” While “feasible and acceptable” is… nice to know… it’s totally unrelated to the FDA’s safety mission statement on ensuring drug safety for the public.
The reasoning that the FDA gives in its report for skirting essentially every safety requirement it had in place decades prior to 2021 and mailing mifepristone wantonly: “The COVID-19 public health emergency” …which in addition to being questionable in 2022 and 2023, Biden has already prospectively decided to end.
In making a regulatory/safety decision for any drug, cumulative safety should be the FDA’s ultimate concern. However, the studies referenced in the FDA’s medical review were mysteriously limited to an approximate three-year window from 2019-2021. Of note, that window only included when Mifepristone was limited to use in a doctor’s office and only through 49 days gestation.
In contrast, today’s unreliable requirements depend on women unreliably self-assessing gestation up to 70 days. The FDA deceivingly states in its review “there have been no new safety concerns identified,” contemptibly ignoring historic ones and omitting multiple, large specially designed safety studies with obviously negative findings, published during the same 2019-2021 time period. It’s an (undergraduate) textbook example of a confirmation bias fallacy — by America’s very own FDA.
It’s also a remarkable deviation from how the FDA crowed about how critical “safety first” was less than two years ago when it had a regulatory “cow” and deviated from its rules about not giving medical advice inappropriately and selectively warning desperate patients, pharmacists and physicians about ivermectin and hydroxychloroquine. In so doing, the FDA deliberately ignored a veritable cornucopia of available clinical data and instead opted for less-tested, outrageously more expensive non-novel, repurposed Paxlovid. Of note, neither hydroxychloroquine nor ivermectin have a REMS warning nor any discernible observational or epidemiological pattern of life-threatening adverse events, unlike mifepristone.
While the FDA didn’t seem concerned with comprehensively assessing mifepristone safety in its official report, it did make sure to now include gender-neutral language in the updated Patient Agreement Form for mailed, at-home abortion.
Who Wrote/Signed FDA’s Mifepristone Review??
Then, there’s what the FDA removed from its report. Generally, FDA redactions of anything related to public health is questionable, but this time the FDA took the unprecedented maneuver of hiding not only its authors of the medical review, but even the name of the FDA division which wrote the report.
That same ~100-page FDA medical review was then signed off by the FDA’s senior executive leadership in less than one hour, with all signer’s names redacted as well. The signature timeline also questions whether or not signers even actually read the entire review.
FDA CDER Leadership Following White House Orders?
Reading between the lines: This was not a safety-based, clinical decision. Mailing abortion pills is quite clearly a partisan response by the White House that ignores safety, women’s health and is a knee-jerk reaction to the Dobbs Supreme Court decision in an effort to chalk up an abortion “win” regardless of the safety risk to America’s women.
The biggest problem is that it’s just one more in a series of dozens of examples of the FDA ignoring clear clinical data pointing in the opposite direction to force through unscientific political rulings.
To be exact: the problem here isn’t so much the White House, but rather the FDA career employees who refuse to reign in White House politicians and forbid this clear safety risk. Normally, the FDA and its purported “non-partisan public health scientists” are supposed to reign in politics and not waiver on drug safety.
Today’s FDA appears to be little more than a marionette performing for the Biden White House and Big Pharma. I had warned over a year ago that this would be a pattern under the FDA’s new CDER leadership, who had spent her entire decades-long career in Big Pharma prior to joining the FDA where she is now in charge of ~7,000 CDER employees and scientists.
The FDA’s clinical and scientific staff is repeatedly being led astray from its public health mission. It should be obvious to anyone that the cumulative safety profile of mifepristone predicts that the FDA’s political decision to allow mailing of abortion drugs for at-home use will lead to otherwise preventable morbidity and mortality in America’s women.
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