In a statement, Jim 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”. by substituting its opinion for the FDA’s expert approval decision-making.
Marcus Schabacker, president and CEO of ECRI, an independent global non-profit organization that advances evidence-based medicine, is concerned about the effect the decisions could have on patient safety. With medical abortion in legal limbo, it creates ambiguity about what healthcare providers can and cannot do. “When the court steps in and creates this kind of uncertainty, it puts patients at risk. That’s what worried us,” he said. “That introduces an additional risk.”
Even if mifepristone eventually becomes unavailable in the United States, 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 empty the uterus. Although 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 final decision is not the final word, however. The FDA could choose to exercise its enforcement discretion, which means it would not enforce the restrictions set by the Kacsmaryk decision. If this happens, it would allow providers to continue prescribing the pill up to 10 weeks of pregnancy and distributing the pill by mail.
“Enforcement discretion is an integral part of the American legal system,” Cohen says. “Just think of all the times you’ve been driving over 55 miles an hour on the freeway and the cops haven’t pulled you over because they’re using their discretion.”
There is no clarity on what will happen next. A week ago, the same day Kacsmaryk’s opinion was delivered, 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 sits in the Ninth Circuit, which puts the decisions of two separate circuits of the court system in direct conflict. This type of conflict usually has to be decided by the Supreme Court, and researchers now assume that the battle over access to mifepristone is headed there.
This morning, United States Attorney General Merrick Garland said the United States Department of Justice would seek emergency assistance from the Supreme Court to block restrictions on mifepristone created by Kacsmaryk’s opinion, which could take the matter to court immediately. With things moving so fast, experts said, it’s impossible to predict what the next move might be.
WIRED will continue to update this story as it develops.
