Abortion issue returns to Supreme Court as DOJ fights ruling on FDA’s pill approval

The Biden administration will ask the Supreme Court to lift newly imposed court restrictions on a popular abortion pill, sending the pregnancy termination issue back to the high court less than a year after its historic decision overturning Roe v. Wade was supposed to return the issue to the states to regulate.
 
At the Justice Department on Thursday, Attorney General Merrick Garland said he would press for “emergency relief” after the 5th U.S. Circuit Court of Appeals, based in New Orleans, temporarily scaled back the period when the two-pill regimen can be taken from 10 to seven weeks of gestation and blocked the delivery of the drug by mail.

“We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care,” Mr. Garland said in a statement.
 
In an order issued just before midnight Wednesday, the three-judge panel sided 2-1 with the Justice Department in staying U.S. District Judge Matthew Kacsmaryk’s preliminary injunction against the Food and Drug Administration’s 2000 approval of mifepristone for use with misoprostol to terminate pregnancies.
 
At the same time, the court kept in place the Texas judge’s temporary hold on the FDA’s 2016 Risk Evaluation and Mitigation Strategy overhaul, which loosened the 2000 safety restrictions on the abortion pill protocol.
 
The 2016 changes extended the approved period for use of the drug from 49 to 70 days after conception, reduced the number of required in-person office visits from three to one, allowed medical providers who are not doctors to prescribe mifepristone, and eliminated the requirement to report nonfatal adverse side effects.
 
The appeals court’s decision means medical providers must abide by the stricter 2000 rules, which also prohibit sending abortion pills via mail, pending the outcome of the lawsuit filed by the conservative Alliance Defending Freedom on behalf of pro-life medical associations and doctors.
 
The court said it will expedite the case and hear oral arguments on its next available date.
 
“Mifepristone users who present themselves to the plaintiffs have required blood transfusions, overnight hospitalization, intensive care, and even surgical abortions,” the court wrote in its ruling. “As a result of FDA’s failure to regulate this potent drug, these doctors have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects.”
 
Pro-life advocates cheered the appeals panel’s decision, even though it softened Judge Kacsmaryk’s outright ban on the abortion pill protocol.
 
“The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” said Alliance Defending Freedom senior counsel Erin Hawley.
 
The American Association for Pro-Life Obstetricians and Gynecologists, one of the plaintiffs, called the ruling a “victory for our patients.”

Statement from Merrick B. Garland on Alliance for Hippocratic Medicine v. FDA Appeals Decision https://t.co/IkBZULyNfD

— Justice Department (@TheJusticeDept) April 13, 2023

Meanwhile, Democrats and pro-choice advocates denounced the ruling. They accused the court of substituting its own judgment for that of the FDA on a medical issue. A group of drug companies and industry investors wrote a joint letter warning that the decision could have a chilling effect on the development and distribution of other pharmaceutical products given FDA approval.
 
“This case should be immediately appealed and the decision must be overturned,” said Rep. Frank Pallone, New Jersey Democrat. “Even if conservative judges are not persuaded by the harm this decision poses to reproductive rights, they must understand it will cast our nation’s drug approval process into chaos if allowed to stand.”
 
The pro-choice group UltraViolet urged the Biden administration and the FDA to “ignore the ruling,” echoing the calls of a handful of lawmakers after Judge Kacsmaryk’s April 7 decision.
 
The Women’s March announced protests Saturday in Washington and Amarillo, Texas. Judge Kacsmaryk sits on the U.S. District Court for the Northern District of Texas.
 
“Let’s call this case what it really is: a manipulation of our judicial system to impose a radical, anti-woman political agenda,” said Women’s March Executive Director Rachel O’Leary Carmona. “The courts have been stacked with radical politicians cloaked in robes, and used forum-shopping to find a fast-track to a Supreme Court completely captured by their agenda.”

Politics and policy

Democrats, who have had recent electoral successes even in some conservative states challenging new abortion restrictions, were quick to condemn the appeals court ruling. White House press secretary Karine Jean-Pierre, traveling with President Biden in Dublin, said Mr. Biden was determined to fight the restrictions.

“We are going to continue to fight in the courts. We believe the law is on our side, and we will prevail,” Ms. Jean-Pierre told reporters.

Adding to the legal confusion is a separate federal judge in Washington state last week who ordered the FDA not to do anything that might curb mifepristone’s availability in 17 states controlled by Democrats that have sued to keep the drug on the market.
 
Two of the 5th Circuit panel’s judges, Judge Kurt Engelhardt and Judge Andrew Oldham, are appointees of President Trump. Judge Catharina Haynes, a George W. Bush appointee, said she would expedite the case for oral arguments but put the lower court block on hold entirely.
 
The 5th Circuit also suspended the FDA’s 2019 approval of the generic version of mifepristone, ordering the manufacturer, GenBioPro, to cease production by Friday.
 
The abortion-pill regimen has become the most common method of pregnancy termination in the U.S. in the past few years, but the court ripped the argument that mifepristone is “safer than ibuprofen.” It noted that the FDA requires a “black box” warning on the drug about “serious and sometimes fatal infections or bleeding.”
 
About 5 million women have used mifepristone since the 2000 approval. The FDA-approved “patient agreement form” for mifepristone says the pill does not work for 2 to 7 out of 100 women who use it, or 100,000 to 350,000 women. Many of those women wind up in emergency rooms, where they have undergone “blood transfusions, overnight hospitalization, intensive care, and even surgical abortions,” according to the decision.
 
Two pro-life medical groups challenged the FDA’s 2000 approval in 2002. The agency denied their petition in 2016, or 14 years later.
 
“The FDA ignored science and placed politics over the safety of women and girls, as well as the lives of countless unborn children,” said Katie Daniel, Susan B. Anthony Pro-Life America state policy director. “Finally, they are beginning to be held accountable.”

FDA data shows that more than 5.6 million women in the U.S. had used the drug as of June, with 4,200 reports of complications. The agency argued strenuously against the Texas court’s findings on the drug’s safety.

“There is no basis in science or fact for plaintiffs’ repeated claims that mifepristone is unsafe when used in the manner approved by FDA,” Justice Department lawyers wrote in seeking a stay of Judge Kacsmaryk’s order.

The Supreme Court overturned Roe v. Wade in its June 24 decision in Dobbs v. Jackson Women’s Health Organization, sending decision-making on abortion back to the states.