When a Texas district judge ruled on Apr. 7 that mifepristone, a drug for inducing abortion, should have its approval suspended—decades after it was granted—the decision didn’t just threaten abortion access. It raised deeper questions about the U.S. Food and Drug Administration (FDA)’s authority and the separation of its regulatory powers from judicial oversight.
“The fact that there is judicial second-guessing of the FDA’s expertise is frightening,” says Ilisa Bernstein, interim CEO of the American Pharmacists Association and a former FDA official who worked at the agency for more than three decades. “To know that a judge who has no scientific training or expertise is making these judgments is frightening.”
What is scaring doctors and drugmakers alike is the possibility that a judge may be able to suspend the FDA’s approval of any drug, no matter how long it’s been on the market or how safe and effective it is.
“A very dangerous precedent”
The Texas ruling is the first in which a judge’s decision questions the FDA’s authority since the agency was created by Congress in 1906, when it passed the Food and Drugs Act. “This kind of ruling sets a very dangerous precedent for FDA’s authority in terms of other medications that might warrant movement into the marketplace,” Dr. Jane Henney, who was FDA commissioner when mifepristone was approved in 2000, said during a press briefing. The decision is currently being appealed by mifepristone’s maker and the U.S. Department of Justice, but if it holds, “we would be entering totally uncharted territory.”
In order to preserve the FDA’s authority over prescription drugs and maintain the integrity of its decisions to approve medications, Lawrence Gostin, director of the World Health Organization Collaborating Center on Public Health Law & Human Rights at Georgetown Law, says the appeals court or the Supreme Court (depending on how far the case proceeds) would have to side with the FDA in striking down the judge’s ruling. If it doesn’t, “it’s open hunting season against all FDA approved drugs,” he says. “The next case could be red state governors or anti-vax advocates challenging COVID-19 vaccines. That would take the nation on a dangerous path.”
The current legal status of mifepristone
The Texas judge’s decision is under appeal, and there’s another curveball: a Washington district court judge issued an opposing ruling in a case filed by attorneys general in 17 states and the District of Columbia questioning FDA’s restrictive prescribing policies for the drug. In that decision, the judge ordered the FDA to keep mifepristone on the market.
Since the Texas judge gave the FDA until Apr. 14 to file an appeal, for now, mifepristone is currently legally available, but that could change if the appeals court does not grant a stay blocking the suspended approval.
Henney says that mifepristone was properly reviewed and evaluated based purely on scientific evidence of its safety and efficacy—a process corroborated by the General Accounting Office, which conducted its own review of the approval in 2008 and concluded that the agency followed standard procedures and was not influenced by political pressure. The drug is very carefully monitored, subject to more prescribing regulations and oversight than most medications. “This ruling really upends something that has become a very safe practice in this country,” Henney said in a briefing.
If the appeals fail and the Texas judge’s ruling stands, removing mifepristone would have a “chaos-inducing” effect on ob-gyn doctors, said Dr. Jennifer Villavicencio, lead for equity transformation at the American College of Obstetricians and Gynecologists, during a briefing. Not only do doctors prescribe mifepristone for abortions in early pregnancy, but they also use the drug in conjunction with surgical abortions in the second trimester to make the operation safer. The combination of mifepristone and another drug, misoprostol, is also to treat miscarriages. Losing the drug “would be devastating from a lot of different perspectives, and a lot of patients would need less-optimal regimens to manage pregnancy loss and abortion care,” said Villavicencio.
Future concerns for other drugs
Regardless of how this case is resolved, it could embolden states to more aggressively question the FDA’s decisions, undermining the agency and promoting a situation where drug approvals could be re-litigated in the courts. “The question of who is in control of food and drug regulation is vital to America’s health and safety,” says Gostin. Until now, that question has been settled: “Congress undoubtedly delegated food and drug regulation to the FDA, and the agency’s sole consideration should be the gold standard of scientific evidence,” Gostin says. “Law and politics should not get in the way. Lay judges shouldn’t be second-guessing the decisions of career scientific professionals who have rigorously reviewed the evidence.”
More than 250 pharmaceutical and biotech executives signed a letter criticizing the Texas judge’s action, noting that if upheld, it would deter drug development, since companies must invest billions of dollars to research, develop, and test drugs before they reach market. If courts can dismiss FDA approval decades after the fact without scientific basis, that “creates uncertainty for the entire biopharma industry,” the letter states. “Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment.”
“It means that in order to get a drug approved, companies will not just have to survive often hundreds of millions of dollars and years of FDA testing scientifically,” said William Schultz, a partner at Zuckerman Spaeder LLP and former deputy commissioner for policy at the FDA, in a press conference. “But then they’ll have to survive challenges in court, which could be immediate—or, as in this case, 20 years later.”
As the legality of the judge’s decision is hashed out in the courts, physicians and patients are trying to make sense of their ever-changing reproductive rights. “We are seeing patients every day and wondering if we can hand the medication over,” said Villavicencio. “There is a chilling effect as physicians try to explain the situation when they don’t fully understand it.”
—With reporting by Haley Weiss
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