PHOENIX — The Food and Drug Administration is urging a federal judge to quash a bid by a Scottsdale-based law firm to block public access to a popular method of terminating a pregnancy used in nearly half the cases of abortion in Arizona.
Attorneys for the federal agency say the lawsuit filed by the Alliance Defending Freedom on behalf of doctors opposed to abortion seeks to upend longstanding scientific determinations of the safety and efficacy of the two-drug regimen “based on speculative allegations of harm offered” that come not only too late but also are “without merit."
“In contrast, issuance of a preliminary injunction would cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades,” wrote Noah Katzen with the U.S. Department of Justice.
What it would not do, he told Judge Matthew Kacsmaryk, is end abortions. Instead, Katzen said, it would leave surgical abortions — or giving birth — as the only option for women.
“An injunction would force them to do so through an invasive medical procedure that increases health risks for some patients and may be otherwise inaccessible to others,” he said. And Katzen called the claims of the doctors — none of whom actually perform abortions — that they are indirectly harmed by the availability of the drugs “speculative” at best.
“Yet they ask this court for emergency relief in the form of a mandatory injunction that would immediately withdraw approval of a safe and effective drug that has been available in the United States for more than two decades — based on speculative allegations of harm and plaintiffs’ untested assertions ... that they know better than FDA whether this drug is safe,” Katzen said. “That request is extraordinary and unprecedented.”
Hanging in the balance is access to the “abortion pill,” which is technically two separate medication together.
The main drug, mifepristone, also known as RU-486, was approved by the FDA as “safe and effective when used to terminate a pregnancy” in accordance with labeling instructions.
Misoprostal was added to the regimen by the FDA after it was determined that the first does not always work by itself. The other drug induces contractions to expel the fetus from the womb.
Erik Baptist of ADF, which describes itself as founded to defend what it says are Christian values in court, wants Kacsmaryk to block access to that drug, too.
Removal of the drugs would affect nearly half the abortions performed in Arizona.
In 2021 — the most recent year for which the state health department has data — there were 6,720 pregnancies terminated using non-surgical procedures, virtually all of them with the two-drug regimen. By contrast there were 7,180 surgical abortions.
In essence, Baptist argues the FDA ignored evidence that the two medications are medically unsafe, charging the agency chose “politics over science.”
“The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an ‘illness’ and argue that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments,” Baptist wrote.
“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion,” he said, calling the FDA’s assertions “transparently false.”
And Baptist said the agency, in granting approval for use in abortions, “needed to disavow science and law” because it never studied the safety of the drugs under labeled conditions of use as required.
Katzen told the judge that wasn’t the case, detailing the steps and safety studies taken since the FDA first approved the drug in 2000. He said all that resulted in increasing the window for use of the drug, from 49 days to 70 and allowing it to be administered with just one office visit so patients could be in an “appropriate and safe location” when cramping and bleeding would begin.
And earlier this year the agency removed the requirement for in-person dispensing.
What’s also missing in the challenge, Katzen said, is other relevant information.
“Plaintiffs fail to acknowledge that the alternatives to mifepristone — surgical abortion or continued pregnancy — also have rates of complications, with childbirths being substantially higher than mifepristone,” he said.
“Plaintiffs identify no sound reason for the court to second-guess FDA’s scientific judgment nor any provision of the federal Food, Drug and Cosmetic Act that supports their contentions,” Katzen told the judge, saying the agency’s decisions were “reasonable and reasonably explained.”
The FDA’s arguments about why the judge should throw out effort to outlaw the abortion pill go beyond the arguments about the safety of the drugs.
Katzen said an injunction requires the person seeking it to establish an “injury in fact.”
“The complaining physicians are not themselves regulated by the FDA, and they do not purport to prescribe mifepristone,” he said.
Instead, Katzen said, the best they can claim is that they will be injured “in a highly roundabout fashion” because other doctors will prescribe the drug to patients, those patients will seek care from them, causing them to divert time and resources, subjecting them to potential liability “and potentially causing them to suffer grief, distress, and guilt.”
“The speculative nature of these claims is self-evident,” he told the judge.
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