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Judges to hear arguments on federal abortion pill appeal

Some are arguing mifepristone was not approved correctly by the FDA more than two decades ago, and that it should be banned nationwide.
Judges to hear arguments on federal abortion pill appeal
Posted at 3:53 PM, May 16, 2023

Abortion access is about to be back up for debate. A Texas judge in April ruled mifepristone, the most commonly used abortion medication in America, was not approved correctly by the Food and Drug Administration more than two decades ago, and that it should be banned nationwide.

That set off a court process now on the steps of the 5th Circuit Court of Appeals in New Orleans, but not before it made a pit stop at the nation's highest court. Seven Supreme Court justices agreed to stay the decision, meaning the drug can still be used pending the Appeals Court decision.

Justices Clarence Thomas and Samuel Alito were the only two to dissent, with Alito writing the drug makers "are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim."

"While we have backup drugs that we can use, this is the most effective one. We know that there will be a substantial harm if it's taken off the market," said American Medical Association President Dr. Jack Resneck.

SEE MORE: Access to abortion pill threatened amid competing rulings

Dr. Resneck says not only is this the main way physicians manage abortions, but miscarriages as well. France first approved the drug 35 years ago, more than a decade before approval in America.

Anti-abortion advocates say the drug was approved too quickly and is not safe for women.

"When it comes to the safety, there's virtually nothing the FDA can do because of the way that this drug acts on a woman's body," said Mary Szoch of the Family Research Council. She says the FDA should be making sure these drugs are safe and believes it hasn't done its due diligence. "They failed to do that in this case, and they should be held accountable for that."

Records show there were four years between the FDA application and approval.

"Even when it first came up for approval, it asked for more and more studies. We have just extensive data. We know that it's safe and effective," Resneck explained.

Medication advocate Kirsten Moore says the FDA is no stranger to these kinds of lawsuits, but up until this case, judges have deferred to the FDA's scientific expertise.

"It's been really more around interpretation of the law," she said. "Congress gave you this authority, they didn't give you this authority. You didn't treat this patent correctly, so this generic is not approved. And that that's split between courts giving FDA deference. FDA also gives courts deference. So if a court orders FDA to do something, FDA typically does it."

SEE MORE: Newsy investigates: Abortion pill's safety record

There are also concerns a decision in favor of opponents of abortion could change the way the courts handle any drug approval by the FDA.

"That is going to have a chilling effect on our ability as drug makers, as drug sponsors, to continue to innovate, because it just throws everything up into the air," Moore explained.

"You can imagine that pretty soon we'd start seeing lawsuits because somebody doesn't like contraceptives, or somebody doesn't like HIV drugs, or somebody doesn't like cancer drugs that happened to have been tested on stem cells," Resneck added.

The appeals court won't give a decision right away, but no matter what the three judge panel decides, it will likely bounce back up to the Supreme Court in the future.

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