Some good pro-life news: The Fifth Circuit Court said yesterday that the U.S. Food and Drug Administration (FDA) erred when it allowed mail order abortion pills in 2016 and 2021. Let’s take a closer look.
Is this a big deal? This is a “significant victory” exclaimed Erin Hawley, an attorney with the Alliance Defending Freedom who argued the case. She continued:
“Today the Fifth Circuit rightly required the FDA to do its job and to restore crucial safeguards for women and girls, including ending illegal mail-order abortion. The FDA will finally be made to account for the damage it has caused to the health of countless women and the rule of law by unlawfully removing almost every meaningful safeguard from the chemical-abortion drug regimen.”
What is the FDA’s history with mifepristone, aka the ‘abortion pill’? The FDA approved the brand name Mifeprex in 2000. Then in 2016 under direction from the Obama administration, they loosened restrictions on distribution of the drug to include the U.S. Postal service. The relaxed standards, according to Ms. Hawley, were driven by politics “without regard to women’s health or the rule of law.”
In a lower court decision in April, Judge Matthew Kacsmaryk has suspended the FDA’s original approval of the abortion pill, writing that the:
“FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
So did that mean that the abortion pill was yanked off the market? No. The challenge was filed after the statute of limitations had expired. However, a three-judge panel on the Fifth Circuit voted 2 to 1 to delay implementation of the FDA’s new, looser standards for the abortion pill.
What are these looser standards? They increased the gestational age at which the abortion pill could be administered from 7 weeks to 10 weeks; they reduced the number of office visits required to get the abortion pill from three to one; they eliminated the mandate for prescribers to report non-fatal adverse events attributed to mifepristone. And in 2021, the pandemic was used as cover to allow the deadly pills to be delivered through the mail.
The court wrote:
“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.”
So what, if anything, has immediately changed? In the short term, nothing. The Supreme Court decided earlier this year to impose a full stay on this case until all appeals have been heard. But Ms. Hawley said that it …
“puts the FDA on notice as well as gives women a reason to maybe think twice about taking mifepristone unsupervised, certainly through the mail.”
Has anyone ever died from taking Mifepristone? Yes, 28 women according to the FDA.
How many adverse events have been reported? 4213 according to the FDA.
How many women were hospitalized because of Mifepristone? 1048 according to the FDA.
How many women experienced blood loss requiring transfusions? 604 according the FDA.
How many women suffered infections? 414 according to the FDA.
In light of the high number of injuries women have experienced from taking Mifepristone, why would the FDA want to eliminate reporting requirements for non-fatal adverse effects? That is a good question. Perhaps you should ask your Congressional representatives to ask the FDA this very question.
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