U.S. District Judge Matthew Kacsmaryk suspended the U.S. Food and Drug Administration’s approval of mifepristone more than 20 years ago, arguing that it was flawed and invalid. Kacsmaryk issued a temporary stay on his ruling for seven days to allow the Biden administration to appeal. The ruling is likely to pull the drug from pharmacy shelves unless a higher court intervenes while the case moves through the appeal process.
But just hours later, a district judge in Washington state issued a conflicting ruling in a separate case, prohibiting the FDA from taking the drug off the market. Despite the confusion caused by these dueling decisions, legal experts say even the threat of a legal gray area is likely to cause providers to stop distributing the drug.
Mifepristone is the first of a two-drug regimen that makes up the majority of abortions in the U.S., according to the Guttmacher Institute, a reproductive health research and policy center. It blocks the pregnancy hormone progesterone and is also used to manage miscarriages.
While the U.S. Supreme Court’s Dobbs decision last June rescinded federal abortion protections, it left intact states’ ability to set their own abortion laws. California legislators and Gov. Gavin Newsom jumped at the chance to make the state a beacon for progressive politics, even approving financial assistance for people in other states seeking abortions in California.
But Kacsmaryk’s ruling addresses the FDA’s authority nationally, and leaves little room for states to mitigate the fallout.
“We’re in uncharted territory,” Lisa Matsubara, an attorney for Planned Parenthood Affiliates of California and vice president of policy, told CalMatters a day after Kacsmaryk heard arguments in the case in mid-March. “It will take some time to understand how this will play out in California.”
The addition of the COVID-19 vaccine to the CDC’s recommended vaccines for kids is not a mandate for states’ school attendance requirements. Any additions to California’s list must be made by the state Legislature or the state Department of Public Health. In the last 12 months, the Newsom administration and the Legislature separately tried to mandate the COVID-19 vaccine for kids to attend school, and both failed.
People involved in those efforts said they do not expect the Legislature to consider a mandate for children again next year, barring a big spike in hospitalizations or deaths.
“Our goal should be getting the immunization rate up,” said Sen. Richard Pan, a pediatrician Sacramento Democrat, whose bill last session would have mandated the vaccine for children to attend school, with only a medical exemption. “We have work to do on outreach, making sure people have access and educating people about the vaccine.”
Since the federal government approved vaccines for children on an emergency use basis, children have received the COVID-19 vaccine at much lower rates than adults. So far, 67 percent of 12-to-17-year-olds have received the first series of the vaccine, 38 percent of children 5 to 11 have received the first series and of those under 5 years of age, 5 percent have received the shots, according to state data.