5th Circuit Court sets off chaos on Mifepristone prescriptions
The nation's most reversed circuit court took Mifepristone off the market Friday. SCOTUS Judge Alito (yes, you read that right) temporarily paused the decision. Here's what's next.
What happened
U.S. abortion opponents, increasingly frustrated with the lack of action by the Trump administration to stem the flow of abortion pills prescribed online. Louisiana AG Liz Murrill asked last month that U.S. Food and Drug Administration rules that allow mifepristone to be dispensed through the mail be paused while a challenge to the FDA’s 2023 regulations moves through the courts. Anti-abortion groups have been pushing for years to reinstate the in-person dispensing requirement, alleging that taking mifepristone at home can be dangerous — despite studies that have found it to be safe and effective.
In January, the FDA requested the case be paused until the agency finished conducting its own safety review of mifepristone. Health Secretary Robert F. Kennedy Jr. commissioned the review last year in response to a report that claimed to find a higher rate of serious complications from mifepristone than reported by the FDA. Researchers labelled the new report “junk science” that exaggerated the risks of the medication.
On April 7, a federal judge refused to block filling prescriptions for the abortion pill mifepristone by mail across the US. An appeal was lodged to the notoriously conservative 5th Circuit Court of Appeals; that court holds the contemporary record for the most SCOTUS reversals.
May 1, the 5th Circuit Court of Appeals in Lousiana blocked access to the mailing of mifepristone prescriptions, one of the one of the most common means of abortion in the US. Drug makers Danco and GenBioProOn immediately filed an emergency appeal to SCOTUS, resulting in a temporary stay until at least May 11.
In 2024, the Supreme Court rejected an earlier attempt to overturn the Food and Drug Administration’s approvals for mifepristone. The court said then that those challenging the approvals did not have legal standing.
The new case focuses more narrowly on the Biden administration’s decision the previous year to make permanent Covid-era rules that made it easier to obtain the drug during the pandemic.
What’s next
Judge Alito ordered Louisiana to file its response to the companies’ request by the end of the day Thursday, May 7.
After the May 1 ruling, chaos ensued with some telehealth services immediately halting prescribing. Some switched to sending only misoprostol, which is less effective and more prone to side effects. After today’s pause, shipping of mifepristone was resumed.
NYT notes that “the Trump administration has been silent on the issue and did not file an emergency appeal to SCOTUS when the drug makers did. The administration may have enough to worry about before midterms. “Legal experts say that a court ruling dictating decisions for a federal agency sets a precedent that could open the door for other states to challenge federal agencies if they disagree with their policies and regulation.
“Pharmaceutical companies, as well as health policy experts, have strongly argued against courts shaping F.D.A. policies, saying that it undermines the kind of evidence-based drug regulation that the industry relies on. Notably, in October, under the Trump administration, the F.D.A. granted approval for a new generic version of mifepristone, increasing the number of American manufacturers to three.”
“Administration officials recently told The New York Times that the review would probably be finished toward the end of this year. If the Louisiana case is paused until then, it would likely mean that any outcome of the F.D.A. review would be less of an issue in the midterm elections, at a time when Republicans are struggling to maintain control of Congress and restricting abortion is not considered a broadly winning issue in many races.” See more here. (gift link)
Stay tuned.