In a statement, Jim Stansell, vice president of the 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 about any court action.” Substituting the opinion for FDA’s expert approval decision.
Markus Schabaker, president and CEO of ECRI, an international independent nonprofit organization that promotes evidence-based medicine, worries about the impact the decisions will have on patient safety. Legalizing medication abortion creates uncertainty about what health care providers can and cannot do. “When the court comes in and creates that kind of uncertainty, it puts patients at risk. That’s what we’re concerned about,” he said.
While mifepristone will eventually no longer be available in the US, medical abortions are still only possible with misoprostol, one half of the two-pill. This medication, usually taken 24 to 48 hours after mifepristone, causes the cervix to dilate and contract, causing the uterus to empty. Although less effective than taking both pills, misoprostol-only therapy is supported by the World Health Organization and the American College of Obstetricians and Gynecologists as an acceptable alternative.
But the final decision is not the last word. The FDA may choose to exercise its enforcement discretion, meaning it will not enforce the restrictions set forth in the Casemaric decision. If that happens, it will allow providers to continue to prescribe the pill up to 10 weeks into pregnancy and give the pill by mail.
“The decision to compel is a normal part of the American justice system,” says Cohen. “Think of a time you drove over 55 miles an hour on the highway and the police officers were using their enforcement discretion because they didn’t show you.”
There is no clarity on what happens next. A week earlier — on the same day as Kaczmaric’s opinion — a federal judge in Washington state ruled that the FDA could make mifepristone available in that state, 16 others and the District of Columbia. Washington State is in the Ninth Circuit, and that puts decisions from two different judicial circuits in direct conflict. Such a conflict usually has to be decided by the Supreme Court, and scholars now predict that the battle over access to mifepristone will go there.
This morning, the U.S. Department of Justice said it would seek urgent help from the Supreme Court to block the mifepristone restrictions created by Kaczmaric’s opinion and would likely take the case to court sooner rather than later. Experts say it is impossible to predict what the next decision will be because things are moving so fast.
WIRED will continue to update this story as it develops.