A Small Victory For The Rule Of Law

On April 7, FDA Approval Of Abortion Pill Mifepristone Was Revoked by a federal judge Matthew Kacsmaryk in Texas, with a 7-day stay for the FDA and other litigants to seek a further stay pending appeal in the 5th Circuit. Top Democrats such as Senator Ron Wyden and Representative AOC called on the Biden administration to “ignore” the ruling.

Today the White House press secretary said the Biden administration rejected calls to ignore the ruling:

“We are going to always follow the law, always,” White House press secretary Karine Jean-Pierre said Monday. “That doesn’t mean that we’re not going to fight.”

Today the FDA filed an Emergency Motion for a Stay Pending Appeal, pointing out not only the contested legal issues, but also the widespread use of mifepristone, which has been used in 5 million abortions (emphasis added):

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More than two decades ago, the Food and Drug Administration (FDA) determined that mifepristone is safe and effective to terminate early pregnancies. FDA has consistently adhered to that judgment across five presidential administrations. During that time, more than five million Americans have chosen to end their pregnancies using mifepristone. Today, more than half of women who terminate their pregnancies rely on that drug. When mifepristone is used as FDA directs, serious adverse events are exceedingly rare, just as they are for many common drugs like ibuprofen.

Rather than preserving the status quo, as preliminary relief is meant to do, the district court upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety….

The district court’s extraordinary and unprecedented order should be stayed pending appeal. Plaintiffs lack standing to challenge FDA’s approval of a drug they neither take nor prescribe; their challenge to FDA actions dating back to 2000 is manifestly untimely; and they have provided no basis for second-guessing FDA’s scientific judgment….

The court’s sweeping nationwide relief was especially unwarranted given the balance of harms: If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity. This harm would be felt throughout the country, given that mifepristone has lawful uses in every State….

Danco Laboratories, which is a distributor of mifepristone and is an intervenor in the case, also filed a similar motion for a stay. The Court has ordered the plaintiffs to respond to both motions by midnight on April 11.

Alliance Defending Freedom, which represents the plaintiffs in this and many other abortion pill cases issued the following statement on the stay motion, attributed to Senior Counsel Erin Hawley:

“By illegally approving dangerous chemical abortion drugs, and imposing its mail-order abortion regime, the FDA put women in harm’s way, and the agency should be held accountable for its reckless actions. Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they can cause serious and life-threatening complications to the mother, in addition to ending a baby’s life. The district court’s ruling last week was a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women and girls. ADF remains committed to their protection.”

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