By Tom Hals, Andrew Goudsward and Brendan Pierson
(RockedBuzz via Reuters) – Federal appeals court judges on Wednesday appeared to voice support for opponents of the mifepristone abortion pill to press ahead with their challenge to its approval by the United States, which has potentially far-reaching consequences for access to the abortion across the country.
Since the high-stakes oral arguments began before the US 5th Circuit Court of Appeals in New Orleans, all three judges on the panel have repeatedly solicited attorneys from the US government and Danco Laboratories, which sells the drug under the brand name Mifeprex.
Circuit Judge James Ho interrupted government attorney Sarah Harrington almost as she began her presentation, questioning her use of “unprecedented” to describe the case.
“I guess I’m just wondering why not just focus on the facts of this case rather than having this kind of FDA that can’t do an issue wrong,” Ho said.
The judges appeared skeptical of the government’s and Danco’s views that the doctors and organizations who filed the lawsuit could not sue because they weren’t harmed by the U.S. Food and Drug Administration’s approval of the drug in 2000.
The government and Danco want the commission to reverse last month’s ruling by US District Judge Matthew Kacsmaryk in Amarillo, Texas, suspending the approval of mifepristone.
The challenge to the drug’s availability comes as Republican-led states have enacted a growing number of bans and restrictions on abortion since the US Supreme Court in June overturned its landmark Roe v. decision. Wade’s 1973 legalization of the procedure nationwide.
Anti-abortion groups and doctors, led by the recently formed Alliance for Hippocratic Medicine, defended Kacsmaryk’s order during Wednesday’s discussion. They claimed in their lawsuit last year that mifepristone is unsafe and that the FDA approval was illegal.
Harrington was interrupted several times by judges when asked to explain why the government believed doctors had no standing to sue.
Emergency room doctors said in court that they were forced to complete surgical abortions, which was against their conscience, for women who took the pill but failed to complete a medical abortion.
“It just strikes me that what the FDA has done to make this more available,” said Circuit Judge Cory Wilson, “has made it much more likely that patients will go to emergency care or a medical clinic where one of these doctors are a member.”
The judges questioned and cut off Erin Hawley, the plaintiffs’ abortion attorney, less than the government and Danco’s attorneys. The toughest questions for Hawley were directed at the timeliness of the plaintiffs’ case, which challenges the FDA’s approval of mifepristone in 2000, as well as the agency’s easing of restrictions on mifepristone in 2016, making it more widely available.
Hawley argued that the FDA’s 2016 actions were “major changes” that reset the amount of time they had to file lawsuits.
The oral arguments ended after about two hours, with little attention given to the merits of the case.
Filing their case in Amarillo, the plaintiffs assured that it would go before Kacsmaryk, a conservative and former Christian activist, and that any appeals would go to the conservative 5th Circuit. Twelve of the circuit’s 16 active judges were appointed by Republican presidents.
All three judges on Wednesday’s panel are staunchly conservative, with a history of opposing abortion rights. Ho and Wilson were nominated by Donald Trump. The third justice, Jennifer Walker Elrod, was appointed by George W. Bush.
Kacsmaryk’s ruling last month alarmed the pharmaceutical industry. Hundreds of drugmakers banded together to push for the decision to be reversed because it undermined the FDA’s authority.
Walker Elrod told Danco’s attorney she was concerned about “unusual remarks” in the company’s briefs, which described the Kacsmaryk ruling as an “unprecedented judicial assault” on the regulatory process.
Those kinds of remarks addressed to a lower court “we don’t ordinarily see from a learned lawyer,” Walker Elrod said.
SAFE AND EFFECTIVE
Mifepristone remains available for now, following an emergency order from the US Supreme Court that stayed Kacsmaryk’s order during the appeal.
Mifepristone is part of a two-drug regimen with misoprostol used for medical abortions, which account for more than half of abortions in the United States. It is approved for use in the first 10 weeks of pregnancy.
Numerous medical studies have concluded that the drug is safe and effective.
Major medical associations, including the American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association (AMA), have argued in court that withdrawing mifepristone from the market would harm patients forcing them to undergo more invasive surgical abortions.
The court could issue its decision in the coming weeks or months and is sure to appeal, first to the 5th Circuit and then to the US Supreme Court.
(Reporting by Brendan Pierson in New York, Tom Hals in Wilmington, Delaware and Andrew Goudsward in Washington, editing by Alexia Garamfalvi and Bill Berkrot)