Similarly, he adds, pharmaceutical investment would become worthless. “The industry has to spend a lot of time and resources doing the hard work of identifying promising drugs and determining whether they are safe and effective for a given use,” she says. “That takes a lot of time and a lot of money. And the incentives to do that hard work to create innovative new products are seismically undermined if there is no certainty about the ability to market a product once it has been shown to be safe and effective.”
Earlier this week, executives from biotech and pharmaceutical companies issued a burning letter condemning Kacsmaryk’s decision as an act of “judicial activism” that puts “an entire industry focused on medical innovation” at risk. The letter has garnered more than 600 signatures and counting. The Biotechnology Innovation Organization, the world’s largest biotechnology trade association, was among the organizations that signed an amicus curia brief asking the Fifth Circuit to stay the ruling until an appeal can be heard.
In a sentenceJim Stansel, executive vice president of Pharmaceutical Research and Manufacturers of America, or PhRMA, called the FDA the “gold standard for determining whether a drug is safe and effective” and said the group has “serious concerns with any court that substitutes its FDA Expert Opinion for Approval Decisions.
Marcus Schabacker, president and CEO of ECRI, an independent global nonprofit organization that promotes evidence-based medicine, worries about the effect that failures could have on patient safety. With medical abortion in legal limbo, he creates ambiguity about what health care providers can and cannot do. “When the court steps in and creates that kind of uncertainty, it puts patients at risk. That’s what we were worried about,” he says. “This introduces additional risk.”
Even if mifepristone eventually becomes unavailable in the US, medical abortion is still possible with just misoprostol, the other half of the two-pill regimen. This medication is usually taken 24 to 48 hours after mifepristone to dilate the cervix and cause contractions, which empties the womb. Although less effective than taking both pills, the World Health Organization and the American College of Obstetricians and Gynecologists endorse a misoprostol-only regimen as an acceptable alternative.
However, the latest ruling is not the last word. The FDA could choose to exercise its enforcement discretion, meaning it would not enforce the restrictions set forth by the Kacsmaryk ruling. If that happens, it would allow providers to continue prescribing the pill until 10 weeks into the pregnancy and deliver the pill by mail.
“Enforcement discretion is a normal part of the American justice system,” says Cohen. “Just think of all the times he drove over 55 miles per hour on the highway and police officers didn’t stop him because they were using his discretion.”
There is no clarity on what will happen next. A week ago, the same day Kacsmaryk’s opinion came in, a federal judge in Washington state ruled that the FDA should keep mifepristone available in that state, another 16 and the District of Columbia. Washington state is in the Ninth Circuit, and that puts the rulings of two separate circuits of the judicial system in direct conflict. That kind of conflict usually must be decided by the Supreme Court, and scholars now assume that the battle over access to mifepristone is headed there.
This morning, United States Attorney General Merrick Garland said that the United States Department of Justice seek emergency help of the Supreme Court to block the restrictions on mifepristone created by the Kacsmaryk opinion, possibly taking the matter to court immediately. With things moving so fast, experts said, it’s impossible to predict what the next failure might be.
WIRED will continue to update this story as it develops.