In a statement, Jim Stansel, executive vice president of the Pharmaceutical Research and Manufacturers of America, or PhRMA, called the FDA the “gold standard for determining whether a medicine is safe and effective” and said the group has “serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making.”
Marcus Schabacker, president and CEO of ECRI, a global independent nonprofit organization that advances evidence-based medicine, worries about the effect the rulings could have on patient safety. With medication abortion in legal limbo, it creates ambiguity about what health care providers can and cannot do. “When the court steps in and creates that kind of uncertainty, it endangers patients. That’s what we worried about,” he says. “This introduces additional risk.”
Even if mifepristone ultimately becomes unavailable in the US, medication abortion is still possible with just misoprostol, the other half of the two-pill regimen. This drug is typically taken 24 to 48 hours after mifepristone to dilate the cervix and cause contractions, which empties the womb. Though less effective than taking both pills, a misoprostol-only regimen is endorsed by the World Health Organization and the American College of Obstetricians and Gynecologists as an acceptable alternative.
The latest ruling isn’t the final word, however. The FDA could choose to exercise its enforcement discretion, meaning it would not enforce the restrictions set by the Kacsmaryk ruling. If that happens, it would allow providers to continue to prescribe the pill up to 10 weeks into pregnancy and dispense the pill through the mail.
“Enforcement discretion is a normal part of the American justice system,” Cohen says. “Just think of all the times you’ve driven over 55 miles an hour on the highway and police officers haven’t pulled you over because they’re using their enforcement discretion.”
There’s no clarity on what happens next. One week ago—on the same day that the Kacsmaryk opinion landed—a federal judge in Washington state ruled that the FDA must keep mifepristone available in that state, 16 others, and the District of Columbia. Washington state lies in the Ninth Circuit, and that puts rulings from two separate circuits of the court system into direct conflict. That kind of conflict usually must be decided by the Supreme Court, and scholars now assume the battle over mifepristone access is headed there.
This morning, US Attorney General Merrick Garland said the US Justice Department would seek emergency relief from the Supreme Court to block the restrictions on mifepristone created by the Kacsmaryk opinion, possibly bringing the issue before the court immediately. With things moving so fast, experts said, it is impossible to predict what the next ruling might be.
WIRED will continue to update this story as it develops.
