All eyes on SCOTUS for abortion pill ruling

By Caitlin Owens

On April 14, 2023

The Supreme Court could rule as soon as today in the legal battle over abortion pills — and could effectively override the Food and Drug Administration’s decision-making if it doesn’t turn back a ruling limiting the use of the drug mifepristone.

Why it matters: Until last week, such a sweeping blow against the FDA’s authority would have been unprecedented. Now it’s a real possibility — one that could quickly threaten access to the pill used in more than half of U.S. abortions.

What to watch: Justices could decide to stay lower courts’ limitations on abortion pills while the appeals process plays out, punting larger questions about the appropriate role the judicial system can play in regard to drug approvals.

• Or, as two federal courts have already, the high court could issue an order that effectively overrides the FDA’s authority.

Driving the news: The 5th U.S. Circuit Court of Appeals’ partial pause of a Texas judge’s ruling was still met by outrage from abortion rights proponents as well as industry groups, who argue the implications extend to the entire pharmaceutical industry.

• The Department of Justice said yesterday that it was appealing the ruling, which allowed the FDA’s authorization to remain in place but imposed restrictions on mifepristone’s use. The FDA had previously lifted those restrictions.
• The decision is set to take effect Saturday, which could lead the Supreme Court to act quickly.

What they’re saying: The 5th Circuit ruling did little to alleviate concerns about judicial intrusion into the regulatory process.

• “The appeals court elevated speculative pseudoscience over data and evidence, arbitrarily rolling back access to a safe and effective drug and leaving millions of women without a critical medication for reproductive health care,” said American Medical Association president Jack Resneck in response to the decision.
• “Judges and lawmakers should not be substituting their own opinion for the experience, expertise, and authority of the U.S. Food and Drug Administration,” he added.

Between the lines: The Texas judge’s ruling called into question the drug’s safety in a way at odds with scientific consensus and found evidence FDA faced political pressure to approve mifepristone to increase access to medication abortion.

• The AMA said it undermined informed decisions, eroded trust in institutions and put individual and collective health at risk.

The other side: The 5th Circuit ruling specifically called out the FDA’s approach to mifepristone as an unusual circumstance.

• “This is an exceedingly unusual regime. In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way,” the court writes.

What we’re watching: The legal process could shake out in any number of ways.

• But unless the Supreme Court pauses the implementation of any changes until the judicial process has played out, the FDA is likely going to have to make some tough decisions.
• Although the agency has used what’s known as enforcement discretion in the past, the option has become equated with the idea of simply ignoring the courts. Anything less than full compliance with any limits on mifepristone will likely be strongly attacked by Republicans.
• On the other hand, imposing new restrictions could defy a separate federal court in Washington state that ruled the agency had to maintain the status quo on abortion pills in 17 states and the District of Columbia.

• “The FDA is caught in the crosshairs. Though the agency prides itself on scientific independence and seeks to avoid the appearance of partisanship, any reaction the agency has to these cases — even a decision not to act — will appear political to one side,” a trio of abortion rights advocates write in an opinion piece in The Guardian.

This piece was republished from Axios.