The abortion drug mifepristone (Mifeprex) entered the U.S. market in 2000. 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.”
These warnings are further reflected and elaborated upon on the websites of the Mayo Clinic and the NIH’s National Library of Medicine.
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 doctors or staff present. No more ultrasounds to confirm gestational age or any in-house monitoring for complications for internal bleeding — for a drug well established to cause life-threatening bleeding.
What changed? Did the FDA just unearth data showing that mifepristone is safer than originally thought? The answer is no.
In fact, mifepristone is so unsafe that it could only be dispensed under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) protocol since 2011. REMS protocols are only issued to high-risk drugs which means that mifepristone is one of the rarely selected FDA-approved drugs that although approved, has unusual “serious safety concerns.”
In its recent decision, the FDA did release a medical review. But anyone looking for scientifically meaningful reasoning based on cumulative safety findings will be both disappointed and outraged.
What they will see are many small, non-safety-focused studies and the redundant authorship of pro-abortionists and study sponsorship from places like The National Abortion Federation and the biased UCSF Bixby Center for Global Reproductive Health.
Indeed, studies referenced were shamefully deceptive, and instead of referencing “safety” used muddy, academically unacceptable language like “unplanned clinical encounters.”
The few studies the FDA relied on for its safety determination were not prospectively, longitudinally, statistically or appropriately designed safety-centric studies despite mifepristone currently being a REMS product.
Further, studies that did reference safety used in-house monitoring and ultrasounds to confirm age of the fetus and evaluate bleeding — which are now omitted. Importantly, the one study the FDA referenced with a noteworthy number of participants required in-patient visits and still concluded increased hospital visits.
The laughable, 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 assuring drug safety
The justification that the FDA gives in its report for skirting essentially every safety requirement it had in place decades prior to 2021: “The COVID-19 public health emergency” … which President Joe Biden has already decided to end.
H/T Fox News (read more at FoxNews.com)
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