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• Posted April 14, 2023

In Emergency Filing, Biden Administration Asks Supreme Court to Keep  Abortion Pill Fully Available

The Biden administration filed an emergency application on Friday that asks the U.S. Supreme Court to pause parts of a recent federal ruling that limit the availability of the abortion pill mifepristone.

On Wednesday, a federal appeals court partially overruled Judge Matthew Kacsmaryk's ruling in Texas last week, which said the U.S. Food and Drug Administration's approval of mifepristone back in 2000 was invalid. The three-judge appeals court panel said mifepristone could remain available for now, but it blocked mailing the pill to patients, as well as other measures the federal government has taken recently to boost access to the medication.

But the government's application brief filed Friday asks the Supreme Court to allow mifepristone to remain widely available while the government pursues an appeal.

The government brief was harshly critical of the Texas ruling suspending approval of the drug, which is typically given as the first of two drugs in a medication abortion.

"The district court countermanded a scientific judgment [the] FDA has maintained across five administrations; nullified the approval of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a health care system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies,"the government's brief said.

Solicitor General Elizabeth Prelogar, representing the FDA, wrote in the brief that the plaintiffs lacked standing to challenge a drug they neither take nor prescribe, and that they had provided no basis for second-guessing the agency's scientific judgment back in 2000, The New York Times reported.

In a second brief, filed by Danco Laboratories, which makes the branded version of mifepristone (called Mifeprex), the company said the federal appeals court's ruling had created "regulatory chaos," the Times reported.

"Leaving the... ruling in place will irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations,"the company's brief said. "The lack of emergency relief from this court will also harm women, the health care system, the pharmaceutical industry, states' sovereignty interests and the separation of powers."

In its preliminary ruling on Wednesday, the federal appeals court suggested a statute of limitations bars any legal challenge to the FDA's original approval of mifepristone. The court also seemed to consider the government's view that removing a long-approved drug from the market would have "significant public consequences."

But it left in place parts of Kacsmaryk's ruling that rolled back a loosening of restrictions on mifepristone by the FDA in recent years. That includes a 2016 move to allow the drug to be used through 10 weeks of pregnancy instead of the initial seven weeks, as well as a decision this year to allow retail pharmacies to dispense the pills.

The battle line over mifepristone was first drawn late last week.

The Texas ruling was swiftly followed by a ruling from Washington state federal judge Thomas Rice that ordered a halt to "any action to remove mifepristone from the market or otherwise cause the drug to become less available."

The two opposing rulings suggest that any final decision on the availability of mifepristone may end up at the Supreme Court.

The Washington state lawsuit originated with Democratic attorneys general who were challenging restrictions in place that made it difficult to obtain mifepristone.

The Texas decision involves a lawsuit filed by a coalition made up of doctors and anti-abortion groups who sought an end to the use of mifepristone, claiming that the FDA's decision 23 years ago to approve the drug was made hastily and without proper regard for its overall safety.

Not just Texas

In a statement released last week, President Joe Biden warned that Kacsmaryk's ruling could affect medicines beyond mifepristone and affect Americans nationwide.

"If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks," Biden said.

Biden added that the ruling "does not just affect women in Texas -- if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state."

Medical abortion now accounts for about half of all abortions in the United States. With the overturning of Roe v Wade last June, obtaining mifepristone and misoprostol for a medical abortion has been seen as a viable option for women who live in states affected by bans who might still want to obtain an abortion.

Mifepristone works by suppressing a hormone that's necessary for pregnancy to continue. The second drug, misoprostol, induces contractions similar to those seen in a miscarriage. In countries where mifepristone is hard to obtain, medical abortions often involve the use of misoprostol alone, although experts believe the efficacy of misoprostol alone is less than the two-drug combo.

Even if the decision to rescind mifepristone's FDA approval is ultimately upheld, experts believe most American women could still access medical abortion, since misoprostol would still remain legal.

More information

Find out more about medical abortion at the Cleveland Clinic.

SOURCES: White House, news release, April 7, 2023; American College of Obstetricians and Gynecologists, statement, April 7,2023, American Medical Association, National Right to Life, statement, April 7, 2023; Danco Laboratories, news release, April 7, 2023; The New York Times