In a statement, Jim Stansel, executive vice president of the U.S. Pharmaceutical Research and Manufacturers Association (PhRMA), called the FDA “the gold standard for determining whether a drug is safe and effective,” and that the group “does not approve of any I have serious concerns about the court,” he said. Substitute that opinion for approval decision-making by FDA’s experts. ”
Marcus Shawacker, president and CEO of ECRI, a global independent nonprofit that advances evidence-based medicine, is concerned about the impact of the ruling on patient safety. As medical abortion faces legal challenges, there is ambiguity about what health care providers can and cannot do. “When courts step in and create that kind of uncertainty, it puts patients at risk. That’s what we were worried about,” he says. “This poses additional risks.”
Even if mifepristone eventually becomes unavailable in the United States, misoprostol, the other half of the two-tablet regimen, will still allow medical abortion. This drug is usually taken 24-48 hours after his mifepristone to cause contractions that dilate the cervix and empty the uterus. Although less effective than taking both tablets, a misoprostol-only regimen has been approved by the World Health Organization and the American College of Obstetricians and Gynecologists as an acceptable alternative.
However, the latest judgment is not final. FDA can choose to exercise its enforcement discretion, which means it will not enforce the limits set by the Kacsmaryk decision. In that case, your health care provider can continue to prescribe the pills until you are 10 weeks pregnant and have the pills dispensed by mail.
“Enforcement discretion is a normal part of the American justice system,” says Cohen. “Think of how the police didn’t stop you even though you were driving over 80km/h on the highway because they exercised their discretion to enforce.”
It’s not clear what happens next. A week ago, the same day Kacsmaryk’s opinion landed, a federal judge in Washington ruled that the FDA should keep mifepristone available in that state, 16 other states, and the District of Columbia. made the decision that there was Washington State is in the 9th Circuit, a court system where decisions from two separate circuits are in direct conflict. Disputes of this sort usually have to be decided by the Supreme Court, and scholars currently assume that the battle over access to mifepristone is headed there.
This morning, U.S. Attorney General Merrick Garland said the U.S. Department of Justice would seek emergency relief from the Supreme Court to block restrictions on mifepristone created by Kaksmalik’s opinion and likely bring the matter to court immediately. Experts say things are moving so fast that it’s impossible to predict what the next verdict will be.
WIRED will continue to update as this story unfolds.
