By Dave Andrusko
Just after 6:30 on Friday evening, the Supreme Court issued a one-paragraph unsigned order granting an emergency application from the Biden administration to maintain FDA approval of mifepristone after the 5th U.S. Court of Appeals placed limitations on the first of two drugs that make up the chemical abortion regimen.
At the request of the Justice Department and Danco, mifepristone’s manufacturer, the high court placed a hold (a stay) on the lower court rulings while the appeals process plays out.
Justice Alito and Justice Thomas dissented. While Thomas did not explain his reasons, Alito did in terse and pointed four-pages.
The lower court wanted to re-impose protective restrictions dropped by the FDA in recent years. Agreeing to restore them would not harm the administration or the public, Alito insisted.
“It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations,” Alito wrote. “Contrary to the impression that may be held by many, that disposition would not express any view on the merits of the question whether the FDA acted lawfully in any of its actions regarding mifepristone.”
The case now returns to another (and probably different) panel of the Court of Appeals which will weigh the underlying issues raised in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA). “Its decision on the merits of the case will likely be appealed to the Supreme Court, and Friday’s order will remain in place until the Supreme Court decides whether to hear such an appeal,” the Washington Post reported.
National Right to Life quickly responded later Friday evening. “We are hopeful that when the court takes up the expedited hearing on May 17 that it will confirm the fact that these drugs are dangerous to women,” said NRLC President Carol Tobias.
“The U.S. Supreme Court gives the 5th Circuit the opportunity to evaluate the case on its merits and review the materials presented to them in a timely fashion,” said Tobias. “What the courts will see is a drug that does not cure a disease or alleviate the symptoms of a disease. It was developed to take the life of an unborn child and always has the potential to harm the mother.”
Erik Baptist, senior counsel for Alliance Defending Freedom that is defending the Alliance for Hippocratic Medicine, said “As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge to the FDA’s illegal approval of chemical abortion drugs and its removal of critical safeguards for those drugs moves forward.”
But as Baptist made clear, “The F.D.A. must answer for the damage it has caused to the health of countless women and girls and the rule of law by failing to study how dangerous the chemical abortion drug regimen is and unlawfully removing every meaningful safeguard, even allowing for mail-order abortions.” Moreover, “We look forward to a final outcome in this case that will hold the FDA accountable.”
Baptist argued that the F.D.A. had not only improperly approved the abortion pill in 2000, he said that mifepristone is also unsafe for women. Dr. Randall K. O’Bannon, Ph.D., director of Education and Research for National Right to Life, concurred.
“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,” Dr. O’Bannon remarked. “Mifepristone has been connected to more than two dozen maternal deaths and thousands of maternal injuries and ‘adverse events.’”
The FDA weakened the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug to allow it to be dispensed and even mailed by pharmacies. Prior to those 2023 changes, the 5th Circuit wrote, the FDA had sapped the protocols for mifepristone by
(1) increasing the maximum gestational age at which a woman can use the drug from 49 to 70 days; (2) reducing the number of required in-person office visits from three to one; (3) allowing non-doctors to prescribe and administer the chemical abortions drugs; and (4) eliminating the requirement for prescribers to report non-fatal adverse events from chemical abortion
The immediate impetus for the fast-moving case was U.S. District Judge Matthew Kacsmaryk’s April 7 decision to suspend FDA approval of mifepristone. He issued a one week temporary stay to allow the government to appeal. Within hours, the Biden administration did so. On Monday the Justice Department appealed to the 5th Circuit.
The following Wednesday a three-judge panel of the 5th Circuit Court of Appeals granted a partial stay, pending appeal. The 5th Circuit kept in place the portion of Judge Kacsmaryk’s order requiring the FDA to restore previous safeguards for chemical abortion drugs. The Biden administration appealed to the Supreme Court and on Friday the Supreme Court ordered a pause.
In the very first paragraph of his opinion, Judge Kacsmaryk wrote
Over twenty years ago, the United States Food and Drug Administration (“FDA”) approved chemical abortion. The legality of the 2000 Approval is now before this Court. Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review — until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition.”But FDA waited 4,971 days to adjudicate Plaintiffs’ first petition and 994 days to adjudicate the second. Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days.
On April 5, National Right to Life released a white paper about the myths involving the Food and Drug Administration’s (FDA) approval and management of mifepristone (generic for Mifeprex).
“Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone)” can be accessed here.