How the Texas abortion pill ruling could affect FDA's authority

Nationwide usage of a pill commonly used for abortions is up in the air after a Texas federal judge ruled last Friday that the Food and Drug Administration improperly authorized the usage of mifepristone more than 20 years ago.

AMARILLO, Texas (Nexstar) — Nationwide usage of a pill commonly used for abortions is up in the air after a Texas federal judge ruled last Friday that the Food and Drug Administration improperly authorized the usage of mifepristone more than 20 years ago.

If U.S. District Judge Matthew Kacsmaryk's decision is upheld, it would restrict access to the abortion medication as soon as this Friday. The Department of Justice appealed the Amarillo judge's order on Monday, calling the decision “extraordinary and unprecedented.”

“If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” the Justice Department wrote.

Denise Harle, senior counsel at the Alliance Defending Freedom — the conservative legal firm that brought the lawsuit — said the FDA did not follow its own protocol when approving mifepristone in the year 2000.

"The FDA in this instance, approved chemical abortion drugs without doing any of the required safety testing, to see what actually would happen to women and teen girls. What's happened since then has been years and years and years of terrible medical complications," she said.

Harle said even if it were a drug that had nothing to do with abortion, she would have the same expectations.

"If there's any other instance in which the FDA failed to follow safety protocols and follow the regulations that govern the FDA, then I hope the FDA is held accountable for that," she said. "the FDA really treated this drug gave it special treatment, because it was abortion."

According to the American College of Obstetricians and Gynecologists and the World Health Organization, medication abortion is proven to be safe and effective when taken as prescribed. It's also the most common way women in America terminate their pregnancies.

Possible ramifications on FDA's authority

Depending on the lawsuit's outcome, it could have much broader implications than on abortion access.

"This case legally isn't really about abortion — although, it is," said Josh Blackman, a law professor at South Texas College of Law in Houston.

Blackman, who has expertise in constitutional law, said the ruling raises questions about judicial authority, when it comes to pulling a drug off of the market.

"If this were ruling is upheld, it would allow a lot of people to sue for a lot of things, not just medicine, but sort of any sort of health policy," he said. "If the FDA has authority put these drugs in the market, then the federal court should not be intervening in that process."

Secretary of the U.S. Department of Health & Human Services Xavier Becerra echoed concerns about the case's possible implications during weekend interviews on several cable news networks.

"If this judge says you can overturn [an FDA approved drug] and 23 years of evidence that shows that it is safe and effective, you've put essentially every drug in America in some sort of risk," Becerra told MSNBC on Saturday.

"It is also an attack on FDA authority to review and approve a right range of safe and effective medication for Americans and could open the floodgates for other medications to be targeted and denied to people who need them," she said.

The Biden Administration's appeal will head to the 5th U.S. Circuit Court of Appeals, where Blackman questions if the conservative court will uphold parts or any of Kacsmaryk's ruling.

“Putting aside the sort of difficult issues concerning abortion and drugs, these decisions were made by the FDA many years ago. There's something called a statute limitation that you have to bring your loss within a certain number of years," Blackman said.

The likelihood this case winds up at the U.S. Supreme Court is increased, based on a possible conflicting order by a different federal judge in Washington state, Judge Thomas O. Rice also ruled Friday in a different case that the federal government should not restrict mifepristone usage, at least in 17 states where Democrats are suing to protect access to the abortion drug in a post-Roe America.