Federal appeals court judges on Wednesday appeared to express support for opponents of the abortion pill mifepristone to pursue their challenge to its U.S. approval, which has potentially far-reaching consequences for abortion access across the country.
From the start of the high-stakes oral arguments before the 5th U.S. Circuit Court of Appeals in New Orleans, all three judges on the panel repeatedly pressed lawyers for the U.S. government and Danco Laboratories, which sells the drug under the brand name Mifeprex.
Circuit Judge James Ho interrupted the government’s attorney, Sarah Harrington, almost as soon 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 have this sort of ‘FDA can do no wrong’ theme,” Ho said.
The judges appeared skeptical of the government’s and Danco’s views that the doctors and organizations who brought the lawsuit could not sue because they have not been harmed by the U.S. Food and Drug Administration approval of the drug in 2000.
The government and Danco want the panel to overturn last month’s ruling by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas suspending mifepristone’s approval.
The challenge to the drug’s availability comes as Republican-led states have enacted an increasing number of abortion bans and restrictions since the U.S. Supreme Court in June overturned its landmark 1973 Roe v. Wade decision that had legalized the procedure nationwide.
Anti-abortion groups and doctors, led by the recently formed Alliance for Hippocratic Medicine, defended Kacsmaryk’s order during Wednesday’s argument. They claimed in their lawsuit last year that mifepristone is unsafe and that the FDA’s approval of it was illegal.
Harrington was interrupted several times by the judges when asked to explain why the government thought the doctors lacked standing to sue.
The emergency room doctors said in court filings they were being 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 in making this more available,” said Circuit Judge Cory Wilson, “is you’ve made it much more likely that patients are going to go to emergency care or a medical clinic where one of these doctors are a member.”
The judges questioned and interrupted Erin Hawley, the attorney for the anti-abortion plaintiffs, less than the government and Danco’s lawyers. The toughest questions for Hawley were aimed at the timeliness of the plaintiffs’ case, which challenges the FDA’s approval of mifepristone in 2000, as well as the agency’s 2016 loosening of restrictions on mifepristone, 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 sue.
Conservative court
The oral arguments concluded after about two hours, with little attention on the merits of the case.
By filing their case in Amarillo, the plaintiffs assured it would go before Kacsmaryk, a conservative and former Christian activist, and that any appeal would go 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 appointed by Donald Trump. The third judge, Jennifer Walker Elrod, was appointed by George W. Bush.
Kacsmaryk’s ruling last month alarmed the pharmaceutical industry. Hundreds of drugmakers banded together to urge the decision 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 sort of remarks directed at a lower court “we normally don’t see from learned counsel,” Walker Elrod said.
Safe and effective
Mifepristone remains available for now, following an emergency order from the U.S. Supreme Court putting Kacsmaryk’s order on hold during the appeal.
Mifepristone is part of a two-drug regimen with misoprostol used for medication abortions, which account for more than half of U.S. abortions. 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 said in court filings that pulling mifepristone off the market would harm patients by forcing them to undergo more invasive surgical abortions.
The court could issue its decision in the coming weeks or months and it is sure to be appealed, first to the full 5th Circuit and then to the U.S. 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)
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