Fifth Circuit Judges Hear Arguments in Abortion Pill Case

A federal appeals court will hear arguments Wednesday in a case that could determine the availability of a drug used in most abortions in the country.

A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit is considering whether to uphold a preliminary ruling by a Texas federal judge that in April overturned the 23-year-old Food and Drug Administration’s approval of the pill . mifepristone.

While the case is still in its early stages and any decision is likely to be appealed, it could ultimately have far-reaching consequences.

If the first court’s ruling is upheld, access to abortion medications would be disrupted in states where abortion is legal, not just those where bans and restrictions are in place. The FDA’s regulatory authority over other drugs could be challenged with other lawsuits, and drug companies say uncertainty about the FDA’s role could complicate drug development in the United States.

The arguments included whether the parties that filed the lawsuit – a coalition of anti-abortion organizations and doctors who don’t prescribe the pill – could show that they would really be harmed if the medication remained available and whether they had too long waited to challenge the approval of mifepristone, the first pill in a two-drug regimen.

Prosecutors allege that mifepristone is unsafe and that the FDA failed to follow proper regulatory protocols when it was approved in 2000 — claims the government strongly disputes, citing years of research and other support for the agency’s actions.

The panel, consisting of two President Donald J. Trump appointees, Justices James C. Ho and Cory T. Wilson, and George W. Bush appointee Jennifer Walker Elrod, declined to make a decision at Wednesday’s hearing. That will come later, although there is no deadline for the judge to decide. Any decision may be appealed, first to the Full Court of Appeal and then to the Supreme Court.

In a preliminary ruling in April, Judge Matthew J. Kacsmaryk of the Northern District of Texas, a Trump appointee who has long opposed abortion, suspended FDA approval of the drug.

Central to the arguments on Wednesday is whether the plaintiffs — four anti-abortion doctors and an umbrella group called the Alliance for Hippocratic Medicine — could show they would actually be harmed if access to and approval of the pill remains unchanged. Lawyers call this demand standing.

In a summary judgment filed with the Fifth Circuit, plaintiffs said the FDA’s continued approval of mifepristone would force emergency room physicians who oppose abortion to treat patients who experience complications after taking mifepristone. The letter said the situation would subject doctors to “tremendous stress and pressure” and put them at odds with their religious beliefs.

The FDA has vigorously disputed that plaintiffs suffered or would suffer real harm from the continued availability of the pill.

The plaintiffs “do not prescribe nor prescribe mifepristone,” FDA attorneys wrote in their briefing. And because many studies have shown that complications of medication abortion are rare, with less than 1 percent of patients requiring hospitalization, anti-abortion doctors are unlikely to encounter patients who need treatment after taking abortion pills , says the government.

A lower court order invalidating the drug’s approval “would upend the status quo based on the court’s highly misguided assessment of mifepristone’s safety,” the FDA added. Mifepristone is also used to help patients who are going through a miscarriage, so any decision in this case may also affect the treatment of a miscarriage.

It is also disputed whether the plaintiffs can even challenge the approval process for a drug that has been on the market for 23 years.

The plaintiffs’ letter alleged that the FDA illegally approved mifepristone in a flawed process that “put politics before women’s health” and then “made politically driven decisions to unlawfully push through a dangerous regimen.”

The government pushed back strongly in its briefing, saying, “The FDA’s actions were amply supported by a record developed over decades of safe and effective use of mifepristone in the United States and around the world.”

The agency also argued that the plaintiffs waited too long to file their case.

“They did not prosecute until more than two decades after the approval of mifepristone,” the FDA’s lawyers wrote.

More than a dozen medical associations filed friend-of-the-court statements in support of the agency.

In a shortmedical associations questioned the reasoning behind a Texas federal judge ruling, saying it was based on “pseudoscience and speculation.”

Judge Kacsmaryk, they wrote, ignored “decades of unequivocal analysis supporting the use of mifepristone in miscarriage and abortion care.”