A federal judge’s recent ruling striking down U.S. Food and Drug Administration (FDA) approval of abortion pill mifepristone is not likely to survive on appeal, legal experts told The Epoch Times.
The court decision is one of many to have followed across the country in the wake of the Supreme Court’s decision in June 2022 in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and found there was no right to abortion in the U.S. Constitution.
The ruling returned the regulation of abortion to the states.
After the ruling by a federal judge in Texas, it was reported that California and New York are stockpiling supplies of misoprostol, another pill used in medication abortions. Misoprostol is also approved for the treatment of gastric ulcers.
New York Gov. Kathy Hochul, a Democrat, condemned the ruling at a press conference on April 11.
“One judge in Amarillo, Texas, thinks he knows better than thousands of doctors and scientists and experts. And not to mention the countless women who’ve used this medication safely for decades,” Hochul reportedly said during a joint event with Planned Parenthood.
“This isn’t just an attack on abortion, it’s an attack on democracy. Courts have never before revoked a science-backed decision made by the FDA,” she said.
The judge issued a preliminary nationwide injunction retroactively staying FDA approval of the drug but also stayed his own order for seven days to give the federal government an opportunity to appeal the ruling, something it has subsequently done.
Risks ‘Not Properly Assessed’
Kacsmaryk described mifepristone, which is also known as RU-486 or mifeprex, as “a synthetic steroid that blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death.”“Because mifepristone alone will not always complete the abortion, FDA mandates a two-step drug regimen: mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother’s womb,” the judge added.
Kacsmaryk wrote that the FDA had not properly assessed the risks posed by the drug before approving it, buckling under political pressure to get it on the market.
In this case, 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.”
“There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”
The FDA’s failure to impose restrictions on the use of the drug “resulted in many deaths and many more severe or life-threatening adverse reactions.”
Anticipating criticism, Kacsmaryk explained why it took “two decades for judicial review in federal court” and blamed the FDA.
“Simply put, FDA stonewalled judicial review—until now. Before [the] plaintiffs filed this case FDA ignored their petitions for over 16 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 [the] plaintiffs’ first petition and 994 days to adjudicate the second. Had FDA responded to [the] 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,” the judge wrote.
Jim Burling, vice president of legal affairs for the Pacific Legal Foundation, a national not-for-profit public interest law firm that challenges government abuses, said the court seemed to be “creative” in finding that the parties had standing to challenge a two-decade-old approval for a drug.
“You could argue that FDA was perhaps a little aggressive in the way it approved this drug, certainly compared to the way it denies other drug uses … cutting it some slack that it would not cut for other medications that take a long time to approve,” Burling told The Epoch Times in an interview.
Cautious Decision Making
Although the 5th Circuit “is one of the most conservative circuits around,” it is probably going to say “‘we’re just going to keep the status quo,’” Burling said.The circuit “is going to be very cautious in deciding what to do next,” he said. The court will likely opt to keep the drug on the shelves until it can conduct what will probably be an expedited, emergency hearing at which it accepts briefings from both sides, he said.
This is a “dramatic” opinion that “basically covers new ground on the issue of standing and covers new ground on the issue of the disapproval of a drug that was approved 20 years ago,” Burling said.
Kacsmaryk made it clear that he is upset with the FDA because in his view the agency was “acting badly” in “probably deliberately stretching things out, but that doesn’t necessarily have a bearing on ... the underlying question of whether the initial approval was correct or not, or the question of whether the challengers had standing or not,” Burling said.
Legal commentator Curt Levey, president of the conservative Committee for Justice, said Kacsmaryk’s decision likely has a limited shelf life.
The conservative-leaning 5th Circuit may affirm the decision but it “will probably go up to the Supreme Court,” Levey said in an interview.
“People in the pro-life community are celebrating” the judge’s decision but it is not clear how long the decision will last, he said.
“I can’t make any predictions about what the Supreme Court would do,” he said, adding that “a very high bar [must be] overcome.”
Levey said there may not be five votes on the nine-member Supreme Court “to undo a drug approval from 20 years ago.”
It is also possible that challenges to mifepristone could be initiated in the states, although that is not the issue in this case, Levey added.
