The Justice Department asked the Supreme Court Friday to intervene in an emergency dispute over a Texas judge’s medication abortion drug ruling, requesting that the court step in now rather than wait for an appeal to formally play out at the federal appellate level.
The case is the most important abortion-related dispute to reach the high court since the justices overturned Roe v. Wade last term. It centers on the scope of the US Food and Drug Administration’s authority to regulate a drug that is used in the majority of abortions today in states that still allow the procedure.
Solicitor General Elizabeth Prelogar said in the filing that it “concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone.”
She said that if the ruling were allowed to stand it would “inflict grave harm on women, the medical system, the agency, and the public.”
Danco, a manufacturer of the drug, also asked the justices to step in on an emergency basis before Friday, with an attorney for the company saying in its filing that leaving the lower court opinion in play will “irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations under the FDCA nationwide.”
“The lack of emergency relief from this Court will also harm women, the healthcare system, the pharmaceutical industry, States’ sovereignty interests, and the separation-of-powers,” the attonrey, Jessica L. Ellsworth, told the justices.
The clock is ticking. If the Supreme Court does not step in, the district court’s ruling, as amended by a subsequent appeals court opinion, will go into effect at midnight CT, and access to the drug, Mifepristone, will be restricted while the appeals process plays out.
Both the government and Danco are asking the court to freeze the lower court opinion, or alternatively, agree to take up the case themselves and hear arguments before the summer recess, a very expedited time frame.
The controversy began when US District Court Judge Matthew Kacsmaryk issued a broad ruling that blocks the FDA’s 2000 approval of the drug, as well as changes the FDA made in subsequent years to make the drug more accessible.
Late Wednesday, the 5th US Circuit Court of Appeals froze part of the ruling. The court said the drug, that was approved in 2000, could stay on the market, but agreed with Kacsmaryk that access could be limited.
The appeals court ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers rather than traveling to a clinic or hospital to obtain the drug in person.
The restrictions also affect the instructions on the label for the medication, shortening the window of obtaining the pill to seven weeks into pregnancy as opposed to 10. It’s possible however that even with the ruling in effect, some providers could go “off-label” and continue to prescribe mifepristone up until 10 weeks. Mifepristone is one of the drugs used for an abortion via medication as opposed to surgery.
Prelogar, the solicitor general, argued in her filing to the Supreme Court that the FDA’s expert judgment should not be challenged.
“FDA has maintained that scientific judgment across five presidential administrations, and it has modified the original conditions of mifepristone’s approval as decades of experience have conclusively demonstrated the drug’s safety,” she wrote, reminding the justices that currently, “more than half of women in this country who choose to terminate their pregnancies rely on mifrepristone to do so.”
She highlighted a key threshold issue in the case, arguing that the doctors opposed to abortion who are behind the suit do not have the legal right to be in court. That is because, she said, they neither “take nor prescribe” the drug, and the FDA’s approval “does not require them to do or refrain from doing anything.”
CNN Supreme Court analyst Steve Vladeck, who is a professor at the University of Texas School of Law, said the 5th Circuit’s ruling “froze the craziest, most harmful parts of Kacsmaryk’s ruling,” but that access to mifepristone is still significantly limited.
“The panel ruled that the challenge to the 2000 approval of mifepristone itself is likely time-barred, so it froze that part of the ruling,” he wrote on Twitter. “But it *didn’t* freeze Kacsmaryk’s block of the 2016 and 2021 revisions that (1) make mifepristone available up to 10 weeks; and (2) by mail.”
Medication abortion has emerged a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year overturned the Roe v. Wade precedent that protected abortion rights nationally.
In November, anti-abortion doctors and plaintiffs brought the lawsuit challenging the FDA’s 2000 approval of the drug and targeting how the agency has since changed the rules around its use in ways that have made the pill easier to obtain.
A split 5th Circuit panel said in its order that it was reinstating the approval of the drug because of certain procedural obstacles the plaintiffs face in challenging it. But the appeals court said that the abortion pill’s defenders had not shown that they were likely to succeed in defeating the plaintiffs’ claims against the FDA’s more recent regulatory actions toward mifepristone.
The appellate order was handed down by Circuit Judges Catharina Haynes, a George W. Bush nominee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump nominees. Haynes, however, did not sign on to some aspects of the order.
The FDA approved mifepristone after a four-year review process. It has shown to be a safe and effective way to terminate a pregnancy in the two-plus decades it’s been on the market. But anti-abortion doctors and medical associations allege that the agency ran afoul of the law by not adequately taking into account the drug’s supposed risks.
This story has been updated with additional developments.
Source: www.cnn.com