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Fifth Circuit Court of Appeals Determines that Food and Drug Administration’s 2016 and 2021 Changes to Mifepristone Were Unlawful

by | Aug 16, 2023

Stay on Lower Court Ruling Remains While Litigation Continues

WASHINGTON, D.C.— Today, a three-judge panel of the Fifth Circuit Court of Appeals, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), determined that when the FDA loosened regulations in 2016 and 2021 regarding the drug mifepristone, it did so unlawfully, failing to give adequate consideration to demonstrated safety issues with the drug.

Today’s decision will not impact the distribution of the abortion drug Mifeprex (generic: mifepristone) until the U.S. Supreme Court weighs in.

“The Fifth Circuit Court of Appeals concluded that the FDA’s actions loosening the regulations involving Mifeprex were unlawful,” said Carol Tobias, president of National Right to Life. “Our hope is that today’s decision will be affirmed by the U.S. Supreme Court.”

“Today’s ruling, though not in effect because of the prior stay by the Supreme Court, would also reinstate long-standing safety protocols for women which were removed during COVID and made permanent because of pro-abortion pressure on the FDA,” said Tobias.

In today’s decision, the court noted:

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.

On April 21st, the U.S. Supreme Court issued an order that stayed the district court’s order and returned the issue to the Fifth Circuit.

Justice Alito dissented from the Court’s order, writing about the original ruling of the three-judge panel of the Fifth Circuit: “It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations.”

The circumstances that existed from 2000 to 2016 were a series of protections meant to reduce the many dangers of chemical abortions.

In the lawsuit, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), the plaintiffs argued that the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses.

On April 13, a different three-judge panel of the Fifth Circuit removed the 2016, 2021, and 2023 changes the FDA had made to the original safeguards it had applied to mifepristone. That three-judge panel left in place the original requirement that it be used only up to 7 weeks of pregnancy, the requirement of three physician visits, removed the ability for the drug to be mailed or dispensed by pharmacies, prevented non-physicians from prescribing the drug and reinstated the reporting requirements for non-fatal adverse events.

The Fifth Circuit action followed a decision by U.S. District Court Judge Matthew Kacsmaryk in the Northern District of Texas who issued a national injunction on the use of mifepristone in chemical abortions.

According to the Guttmacher Institute, the research organization affiliated with the abortion industry, approximately 54% of all abortions are done using chemical abortion methods like mifepristone and misoprostol.

Mifepristone is used in combination with misoprostol, a prostaglandin, to cause an abortion. Mifepristone blocks progesterone, leading to the death of the unborn baby, while the second drug, misoprostol, causes powerful, painful uterine contractions to expel the dead or dying baby.

The FDA recently weakened the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug to allow it to be dispensed and even mailed by pharmacies.

“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,” said Dr. Randall K. O’Bannon, Ph.D., director of Education and Research for National Right to Life.

One of the common myths about the drug is that it is “safer than Tylenol” (or a similar argument is that it is safer than Advil/Ibuprofen). Dr. O’Bannon recently addressed this:

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 only 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.

Additional myths are addressed in a white paper National Right to Life released on April 5. Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone) can be accessed here.

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