Kacsmaryk ruling against FDA on mifepristone appealed by Justice Dept.
Kacsmaryk had said his ruling — issued late Friday — would not take effect until this Friday, giving the Biden administration time to appeal before the drug could be pulled from the marketplace. In its filing Monday, the government asked the 5th Circuit judges to keep the order on hold until the appeal is decided.
The judge’s ruling, Justice Department lawyers said, “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 government and the drug manufacturer, Danco Laboratories, asked the appeals court to issue its decision on pausing Kacsmaryk’s order by noon Thursday. In a brief order late Monday afternoon, the 5th Circuit asked the groups challenging mifepristone’s approval to file their response by midnight Tuesday.
If the appeals court does not pause Kacsmaryk’s order while the appeal is decided — or is slow in making that decision — the Justice Department could go directly to the U.S. Supreme Court in an effort to keep mifepristone available for women seeking to terminate pregnancies. The high court will almost certainly hear the case eventually, either before or after the 5th Circuit rules.
The case would present the Supreme Court with its biggest test on abortion access since its landmark decision in June to knock down the federal guarantee of abortion rights provided by Roe v. Wade. The Texas lawsuit comes as more than a dozen states have effectively banned abortions in the post-Roe era, and as abortion opponents are pushing state legislatures and courthouses to restrict access to the procedure elsewhere in the country.
Kacsmaryk’s ruling has had far-reaching effects. California Gov. Gavin Newsom (D) announced Monday that he has secured an emergency stockpile of up to 2 million doses of misoprostol — the pill that is typically used alongside mifepristone in a two-step regimen to perform medication abortions. Misoprostol can be used on its own to terminate a pregnancy, but studies show it is less effective than the two-step regimen and usually causes more cramping and bleeding. In Massachusetts, Gov. Maura T. Healey announced that she is stockpiling mifepristone, with 15,000 doses — enough to last a year in the state — expected to arrive this week.
In their appeals, the Justice Department — which is representing the FDA — and Danco said the antiabortion groups challenging mifepristone lack sufficient legal grounds, or standing, to proceed.
To establish standing, the groups have to demonstrate that they face a risk of injury. The Justice Department characterized as speculative the doctors’ claims that they are directly harmed because their patients claim to have experienced complications from the medication. Mifepristone was approved 23 years ago after clinical trials including thousands of pregnant patients showed a low rate of complications. Since the FDA approved the drug, more than 5 million women in the United States have used the drug to terminate pregnancies.
“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 appeal said.
More than 250 pharmaceutical executives separately criticized the Texas decision in a public letter, saying it “ignores decades of scientific evidence and legal precedent.”
Both abortion foes and abortion rights advocates view the Texas lawsuit as a landmark case that would shape abortion access in the United States.
In November, conservative groups filed a lawsuit in Kacsmaryk’s Amarillo courthouse seeking to reverse the FDA’s approval of mifepristone as safe and effective, including in states where abortion rights are protected.
Kacsmaryk, a lifelong abortion opponent, is the sole judge in his district and has been a go-to judge for conservatives seeking to challenge Biden administration policies. In a four-hour hearing last month, the attorneys for the conservative group argued that mifepristone is unsafe — a claim that has been rejected by medical experts — and that the FDA did not follow proper protocol when approving its use.
The government’s attorneys argued that the scientific evidence has repeatedly proven mifepristone to be safe and effective since the FDA approved its use more than 20 years ago.
Both groups acknowledged in the hearing that there is no precedent for a court to order the suspension of a long-approved medication.
Separately, a group of Democratic state attorneys general filed a lawsuit in February in Washington state seeking to expand access to mifepristone.
Shortly after Kacsmaryk issued his ruling Friday, Judge Thomas O. Rice delivered his ruling in the Washington state case, ordering the FDA to preserve “the status quo” and retain access to the abortion medication in the 17 states — along with D.C. — that filed the lawsuit.
Even the Justice Department was somewhat unclear about the path forward, given the conflicting rulings. On Monday, the agency asked the judge in the Washington state case for clarification on how to reconcile the contradictory opinions.
“The Court did not address the interaction between the two orders, presumably because they were issued less than 20 minutes apart,” the Justice Department wrote. “To ensure that Defendants comply with all court orders in these unusual circumstances, Defendants respectfully request that this Court clarify their obligations under its preliminary injunction in the event that the [Texas] order takes effect and stays the approval of mifepristone.”
Legal experts says that the conflicting orders have thrust the FDA into an unprecedented bind, imperiling the agency’s authority to approve and regulate medications. Congress empowered the FDA, not states, to approve the use of new drugs, and the Justice Department has said that allowing abortion pill opponents to undercut the FDA’s judgment could spark challenges to other approved drugs and fuel public distrust of the process.
“We stand by the FDA’s approval of mifepristone, and we are prepared for a long legal fight,” White House press secretary Karine Jean-Pierre said at a news conference Monday. “That’s what I can say from here. ”
Across the country, abortion clinics are continuing to prescribe mifepristone as they wait to find out whether Kacsmaryk’s ruling will take effect at the end of the week. Several clinic directors said they have been speaking frequently with their lawyers, who are reviewing the decision and parsing its implications.
“We are going to wait for more information, especially from the FDA,” said Tammi Kromenaker, director of Red River Women’s Clinic in Minnesota.
Even if Kacsmaryk’s ruling stands, several clinics said they do not plan to change their protocols until they are explicitly directed to do so by the federal government.
“This judge is not telling our physicians what to do,” Kromenaker said. “This judge is telling the FDA what they can and can’t do.”
In its appeal filed Monday, the drug manufacturer Danco called Kacsmaryk’s ruling an “extreme outlier” and an “unprecedented judicial assault” on the nation’s regulatory process. Blocking access to the most widely used abortion medication in the United States, the company said, will force many patients to chose surgical abortion and interfere with the doctor-patient relationship.