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 Thursday, Attorney General Merrick Garland said he would press for “emergency relief” after the New Orleans-based 5th U.S. Circuit Court of Appeals scaled back temporarily the two-pill regimen from 10 to seven weeks’ gestation and blocked the delivery of abortion drugs 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,” said Mr. Garland 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 pregnancy termination.
At the same time, the court kept in place the Texas judge’s temporary hold on the FDA’s 2016 Risk Evaluation and Mitigation Strategies 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 non-doctors to prescribe mifepristone; and eliminated the requirement to report non-fatal adverse side effects.
The appeals court’s decision means that 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 also said it will expedite oral argument on the case 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 ADF 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.”
Meanwhile, Democrats and pro-choice advocates denounced the ruling, accusing the court of substituting its own judgment for that of the FDA on a medical issue. A group of drug companies and industry investors penned a joint letter protesting the decision as well, warning it 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 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 it would hold protests Saturday in Washington, D.C., and Amarillo, Texas, where 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 seen recent electoral successes even in some red states challenging new abortion restrictions, were quick to condemn the appeals court ruling. White House press secretary Katrine Jean-Pierre, traveling with President Biden in Dublin, Ireland, Thursday, said Mr. Biden was determined to fight the new pill 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 last week that ordered the FDA not to do anything that might curb mifepristone’s availability in 17 states controlled by Democrats which have sued to keep it on the market.
Two of the 5th Circuit panel’s judges, Judge Kurt Engelhardt and Judge Andrew Oldham, are appointees of former President Trump. Judge Catharina Haynes, a 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 in the last few years become the most common method of U.S. pregnancy termination, but the court ripped the argument that mifepristone is “safer than ibuprofen,” noting 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, which translates to 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.”
The FDA’s own data say that more than 5.6 million women in the U.S. had used the drug as of June 2022, with the agency receiving 4,200 reports of complications from women who used the pill, and the agency argued strenuously that against the Texas court’s findings on the safety of the drug.
“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, sending decisionmaking on abortion back to the states.
• Valerie Richardson can be reached at vrichardson@washingtontimes.com.
• Alex Swoyer can be reached at aswoyer@washingtontimes.com.