Judge Kacsmaryk harshly criticizes FDA for its handling of chemical abortions, issues preliminary ruling invalidating agency’s approval

By Dave Andrusko

On Friday evening, in a much anticipated decision, U.S. District Judge Matthew J. Kacsmaryk ruled that the FDA’s approval of mifepristone, the first of the two drug chemical abortion technique, should be enjoined. He issued a one week temporary stay to allow the government to appeal. Within hours, the Biden administration said it would. On Monday the Justice Department appealed to the 5th circuit.

Chemical abortion is the method used in more than half of abortions in the United States.

The lawsuit was brought by the Alliance Defending Freedom on behalf of pro-life medical organizations and four doctors who say they have treated women with mifepristone. Judge Kacsmaryk held “that both the initial approval of the pills in 2000 as well as more recent FDA decisions allowing them to be prescribed via telemedicine, sent by mail and dispensed at retail pharmacies, are unlawful,” Politico’s Alice Miranda Ollstein wrote

“The Justice Department strongly disagrees with the decision,” Attorney General Merrick Garland said in a statement. The decision “overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective.”

The administration could appeal to the 5th Circuit “but the Biden administration might not want to wait for the 5th Circuit to act before bringing the issue to the Supreme Court,” The Washington Post reported.

Pro-lifers hailed the decision for “shining a light on something that the Biden Administration wants to sweep under the rug – that these drugs do not treat or cure disease but kill unborn children and expose their mothers to dangerous side effects,” said Carol Tobias, president of National Right to Life. “The FDA should be in the business of ensuring safety, not in taking lives.” 

Tobias added, The abortion industry has pushed for lowering protections for women undergoing a chemical abortion, while it peddles lies about the ease of the method.”

Erik Baptist, senior counsel with Alliance Defending Freedom, said in a statement Friday that the FDA “never had the authority to approve these hazardous drugs and remove important safeguards. This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls.”

 “Pro-life Americans have always been deeply invested in protecting the most vulnerable members of our society,” added pro-life champion Rep. Chris Smith [R-NJ] “While the FDA has enabled the abortion industry to prey on women and girls during their most vulnerable moments of need, today’s decision finally puts the health of women first—protecting them from the known and unknown risks of chemical abortion.”

Meanwhile, in a separate case regarding the status of the FDA’s approval of mifepristone, Judge Thomas Rice of Washington’s Eastern Federal District Court “granted the preliminary injunction requested by the plaintiffs, made up of Democratic attorneys general, and prevents the FDA from ‘altering the status quo and rights as it relates to the availability of mifepristone,’” ABC News reported. Ultimately, “Rice did not order the FDA to roll back any of its restrictions of mifepristone in his Friday ruling, but he ruled that the status quo must remain” in the 17 states and the District of Columbia which filed the second lawsuit, Ann E. MarimowCaroline Kitchener Perry Stein, and Robert Barnes wrote for The Washington Post.

“The lawsuit filed in Washington state was intended to be a direct challenge to the Texas case,” The New York Times’s Pam Belluck reported.

The Democratic attorneys general filed the case in late February on the first day that Judge Kacsmaryk could have issued a ruling. While its main claims sought to eliminate a framework of extra restrictions that the F.D.A. has long applied to mifepristone, the suit also asked the judge to declare that the F.D.A.’s “approval of mifepristone is lawful and valid” and to enjoin the F.D.A. “from taking any action to remove mifepristone from the market or reduce its availability.”

According to CNN’s Tierney Sneed, the contrast between the two opinions was pronounced.

“In a striking split screen to the ruling out of Texas, where US District Judge Matthew Kacsmaryk in Texas tore apart the process the FDA used to approve the drug, mifepristone, which is the first drug used in a two-drug regime to terminate a pregnancy, Judge Thomas Owen Rice in Washington state took a more deferential tone toward to the FDA, ordering that the status quo be maintained by keeping the drug on the marker,” she wrote.

“It is not the Court’s role to review the scientific evidence and decide whether mifepristone’s benefits outweigh its risks without REMS and/or ETASU. That is precisely FDA’s role,” Rice said. But he said “the record demonstrates potentially internally inconsistent FDA findings regarding mifepristone’s safety profile.”

The lawsuit before Judge Kacsmaryk struck the FDA’s lackadaisical approach to mifepristone at its most vulnerable points, beginning with an abysmal failure to address legitimate questions in a timely fashion.

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.

 Judge Kacsmaryk went on

“Contrary to popular belief and talking points, the evidence shows chemical abortion is not ‘as easy as taking Advil.’ Compelling evidence suggests the statistics provided by FDA on the adverse effects of chemical abortion understate the negative impact the chemical abortion regimen has on women and girls.)

Roughly half way through the 67-page opinionJudge Kacsmaryk wrote

”The court does not second-guess F.D.A.’s decision-making lightly. But here, F.D.A. 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 F.D.A. faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”

 Promoters of these pills “like to trumpet high safety rates, but neglect to mention how that with hundreds of thousands of women taking these pills, even a couple of percentage points of women hemorrhaging, dealing with infections, and 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.

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.