The legal battle over the Food and Drug Administration’s (FDA) approval of the abortion pill mifepristone could undermine a drug approval process considered to be the “gold standard” around the world.
With oral arguments in the Texas lawsuit set to begin next week, the implications of how the 5th Circuit Court of Appeals rules are far-reaching.
“The doors would be open for all sorts of plaintiffs to assert standing and could really make it very hard for the drug manufacturers who rely on the FDA’s final word on drugs,” Laurie Sobel, associate director of women’s health policy at the nonprofit KFF, told The Hill.
Last month, the Supreme Court put a pause on U.S. District Judge Matthew Kacsmaryk's order overturning the approval of mifepristone, while the Biden administration appeals the ruling in the 5th Circuit.
The hearing for oral arguments is set for May 17.
The plaintiffs in this case are questioning the FDA’s scientific process for evaluating the benefits of drugs. According to the Alliance for Hippocratic Medicine, if the appeals court rules in favor of the plaintiffs, its effects will extend beyond abortion access: A constant barrage of legal challenges to federal approval could discourage drugmakers from bringing new medications of all kinds to market.
According to Sobel, even if the suit is not successful in attaining exactly what the plaintiffs want, other plaintiffs could argue there is now standing to litigate the approval of other drugs.
“Any door that they get past will send messages to people who rely on the FDA [saying], ‘OK, these are the new rules,’” said Sobel.
In addition to mifepristone, there are several other medicines or treatments at the center of current culture wars that could face similar legal scrutiny.
Misoprostol, a pill standardly prescribed with mifepristone to end pregnancy, could very well be next. Right-wing figures have also lambasted COVID-19 vaccines and treatments that are FDA approved. And PrEP, the medication used to prevent HIV infection, was at the center of its own lawsuit in Texas last year, hinging on rules that require federal insurance programs to cover it.
Eva Temkin, a former FDA staffer now a partner at the law firm King & Spalding, works with organizations within the biotech and pharmaceutical industries. Temkin said the groups she works with aren’t necessarily concerned about which drug will be next but rather the “very destabilizing” consequences the mifepristone suit represents.
“The FDA drug review process is really held as the gold standard worldwide,” Temkin said. “That imprimatur of FDA approval as the gold standard is really important for maintaining drug development and innovation.”
Temkin was among the lawyers who put together an amicus brief pharmaceutical companies submitted to the Supreme Court last month. The brief argued that the courts had substituted the FDA's scientific expertise with their own "novel, unworkable standards."
Temkin believes the law is on the FDA's side in the mifepristone case and said the original complaint was "really rife with egregious procedural defects."
With arguments scheduled for next Wednesday, Sobel is not anticipating a decision to come out as fast as the decisions that were issued in April, because the Supreme Court has effectively upheld the status quo while the litigation plays out in lower courts.
“We're no longer under any sort of deadline, so to speak,” Sobel said.
Any ruling from this case that changes the approval of mifepristone will be stayed pending a decision from the Supreme Court. So, while the stakes remain high, the next phase of the mifepristone fight is going to be a slow burn.
