Rekubit Exchange:How 5th Circuit Court of Appeals mifepristone ruling pokes holes in wider FDA authority

By interfering with the Food and Rekubit ExchangeDrug Administration's authority to regulate an abortion drug, the courts have undermined its authority over all medications, legal and medical experts told USA TODAY.

"The meaning of FDA approval will always be unclear now," said Dr. Peter Lurie, a former FDA associate commissioner for Public Health Strategy and Analysis. "Is (approval) just something that has not yet been reversed? Will it be subject to some extended legal process, which will be called into question in all kinds of ways?"

"From the agency's point of view," he said, "its very essence is at stake."

The 5th Circuit Court of Appeals Tuesday ruled the FDA overstepped its authority when it allowed the abortion drug mifepristone to be delivered by mail, administered by a pharmacist and given to women further along in their pregnancy than the initial label allowed. The ruling somewhat dialed back a Texas court, which had argued the FDA should not have approved the drug in the first place.

The decision will not take effect immediately because of an earlier Supreme Court decision that paused any changes to the status quo, though it might make some people think they don't have access, said Carl Tobias, a law professor at the University of Richmond.

The ruling, which contradicts one made by the D.C. Circuit Court, will be appealed to the Supreme Court, which will almost certainly take up the case, Tobias said.

A central question, he and other legal experts said, is whether the ruling will affect the FDA's ability to make medical decisions going forward and whether its past decisions will also be questioned by the courts.

"I'm cautiously optimistic that FDA will move on and keep doing the high-quality work it's always done," said Tobias, who has served as a legal consultant to the FDA. He said he hopes the political nature of the abortion debate will make it an exception, though he remains concerned about the potential for broader implications of the decision.

Others were more worried the decision could undermine the FDA's decisions on other scientifically validated but politically controversial approvals, such as those involving COVID-19 vaccines and treatments, needle exchanges and opioid inhibitors.

Even companies that want to promote their product, such as a new Alzheimer's drug, might sue to overturn an FDA decision on a competitor's drug, said Lurie, now president and executive director of the Center for Science in the Public Interest, a watchdog, consumer advocacy agency.

The FDA follows a careful, scientific process designed to treat all companies and products equally and to protect public safety ‒ a process the latest court decision undermines, he and others said.

"Judges with no scientific knowledge are micromanaging the decisions of career professionals at the FDA," said Lawrence Gostin, who directs the O’Neill Institute for National and Global Health Law at Georgetown University. "If the Supreme Court would uphold this, it would unleash vast litigation against the FDA, even well beyond abortion."

I. Glenn Cohen, an expert in health law policy at Harvard Law School, said the ruling "subjects the FDA decision making in this case to a very detailed scrutiny and second guesses FDA review of some of the evidence."

Courts handled challenges to the FDA differently in the past, he said. "It is hard to know if that’s an attitude that really is being influenced by the connection to abortion or a signal to the agency to expect this kind of very deep review more generally."

Judges do not have the scientific expertise to analyze the data that FDA considers on products like mifepristone, the experts said.

FDA officials were particularly careful in their investigation of mifepristone because of the public scrutiny, Lurie said, ensuring through clinical trials that it was safe for pregnant people to diagnose themselves, to safely administer the drug and to understand the labeling material.

While the court decision won't have an immediate effect, pharmaceutical industry representatives worry about long-term consequences.

"We remain concerned about the destabilizing effect this decision could have on FDA's drug safety determinations," said Jim Stansel, executive vice president and general counsel of PhRMA, which represents the pharmaceutical industry. "Congress gave the agency authority to evaluate the safety of medicines, and that certainty is vital for patients, providers and manufacturers alike.”

The American Medical Association also criticized the court's decision on mifepristone, affirming its safety and saying, "The FDA approval process is one that is based on extensive, evidence-based, scientific review of efficacy and safety. Continued efforts to insert the ideology of judges and courts to question sound regulatory science and evidence-based review of therapeutics poses a significant risk to our drug approval process and may ultimately serve to stifle innovation in the pharmaceutical space."

The FDA declined to comment, saying through a spokesperson only that it "does not comment on possible, pending or ongoing litigation."

Contact Karen Weintraub at [email protected].

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.