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FDA’s actions with Mifepristone were unlawful says Fifth Circuit Court of Appeals

Supreme Court Stay Remains While Litigation Continues



On August 16th, the Fifth Circuit Court of Appeals did the world a favour and exposed the FDA’s unlawful actions in 2016 and 2021 of loosening regulations pertaining to the drug Mifepristone. The court found that the FDA failed in its duty to adequately consider the safety issues of women who take the drug.


The decision in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), will not change the distribution of the abortion drug until the U.S. Supreme Court weighs in. The ruling, which will not go into effect due to the prior stay by the Supreme Court, would reinstate safety protocols for women which were removed by the FDA.


In the 5th Circuit Court’s decision, the panel of three judges wrote:


We affirm the portions of the stay order regarding the 2016 Amendments and the 2021 Non-Enforcement Decision. In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those “major” and “interrelated” changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.


This decision upheld a previous Fifth Circuit Court decision, on April 13th, that had also challenged the FDA's removal of vital safeguards in 2016, 2021, and 2023.


That three-judge panel restored the original requirements that the abortion drug be used only up to 7 weeks of pregnancy, the requirement of three physician visits, and they removed the ability for the drug to be mailed or dispensed by pharmacies. They also prevented non-physicians from prescribing the drug and reinstated the reporting requirements for non-fatal adverse events.


The Fifth Circuit Court actions have come about because U.S. District Court Judge Matthew Kacsmaryk had issued a national injunction on the use of mifepristone in chemical abortions.

The abortion drug, Mifespristone, blocks progesterone, the main hormone that supports fetal development. It is used in combination with misopristol which causes the powerful contractions which expel the baby. Today, approximately 54% of all abortions are done using these chemical abortion methods.


One of the more serious myths surrounding this deadly drug is that it is safer that Tylenol. This myth must be exposed and is done so brilliantly by Dr. O’Bannon, Ph.D., director of Education and Research for National Right to Life. He writes:


What you have here is a not-so-clever statistical sleight of hand, where advocates try to get you to compare the number of deaths from a relatively lightly used product with one that is used billions of times by people every year.


We are told that about 150 Americans die from Tylenol use every year, usually by overdose or simply taking too much over an extended period of time. At the same time, the FDA tells us that there have been 28 deaths that we know of among American mifepristone patients since the drug was approved in 2000.


So, 28 deaths from mifepristone in twenty years against 150 deaths from Tylenol in just a single year’s time? Sounds like mifepristone is safer.


But wait. That’s 150 Tylenol deaths against a backdrop of 25 billion doses of Tylenol in a year. We’re told that there have been 5.6 million total chemical abortions with mifepristone in the U.S. since that 2000 approval, less than a thousandth of the sales of Tylenol in a single year.


Note what this does to your risk factor.


Using the minimal figures provided by the FDA, your risk of dying from taking mifepristone is about 1 in 200,000. Not large, but not negligible. And remember that your risk of a complication putting you in the emergency room is closer to one in 10.


But your risk of death from Tylenol is actually something like one chance in 166.7 million, even including those who overdose and fail to follow the manufacturer’s instructions.


This means that your risk of dying from mifepristone is about 833 times your risk of dying from Tylenol.


He goes on to say:


When hundreds of thousands of women take these pills, even a couple of percentage points of women hemorrhaging, dealing with infections, or ectopic pregnancy, represents thousands of women desperately seeking treatment, which may or may not be nearby.


His paper "Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone)" can be found here.


The new decision by the Fifth Circuit Court of Appeals can be accessed here.






Cover Photo by Zach Camp on Unsplash

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