The Supreme Court extended the stay deadline to Friday at midnight to keep mifepristone on the market in the interim without conditions.
Pictured: Judicial gavel and scales of justice/Courtesy iStock
Update (April 20) All New Information:
On Wednesday, the Supreme Court extended the stay deadline to Friday at 11:59 p.m. EST to keep mifepristone on the market in the interim without conditions.
The court voted 6–3 and did not offer an explanation for the extension.
Friday, Supreme Court Justice Samuel Alito issued an administrative stay on a Texas court ruling that would have blocked the sale of the widely used abortion pill mifepristone.
Alito’s decision is in response to an emergency appeal by Pres. Biden on behalf of the FDA, and Danco Laboratories, LLC, which manufactures mifepristone. The stay will be valid until April 19, 2023.
The Alliance for Hippocratic Medicine, which initially brought the case against the FDA in November 2022 and sought to withdraw the regulator’s approval of the abortion pill, has until noon on April 18 to respond.
In their lawsuit, the Alliance alleged that the approval of mifepristone was riddled with politics and that the FDA failed to evaluate the drug’s safety thoroughly.
Last week, District Judge Matthew Kacsmaryk ruled in favor of the Alliance and issued a preliminary injunction to block the sale of mifepristone. In his 67-page decision, Kacsmaryk wrote that the plaintiffs had a “substantial likelihood of prevailing on the merits” of their motion and that the FDA had violated its statutory duty by approving the drug based on “unsound reasoning and studies that did not support its conclusions.”
In response to the ruling, President Joe Biden and Vice President Kamala Harris issued statements promising their administration would fight to preserve access to mifepristone.
A few days later, an appellate court blocked the ruling only partially. The Fifth Circuit Court of Appeals ruled to uphold mifepristone’s approval but kept Kacsmaryk’s restrictions on its distribution, disallowing the drug’s delivery by mail and without a doctor’s sign-off.
In the FDA’s appeal, filed for it by the Office of the Solicitor General, the Agency insisted that mifepristone is a safe drug, backed by several studies that have found that, when taken according to its label and in line with its approved conditions of use, serious side effects are “’exceedingly rare.’”
If the lower courts’ orders are allowed to take effect, the FDA argued, it would “thwart FDA’s scientific judgment and undermine widespread reliance in a healthcare system that assumes the availability of mifepristone as an alternative to more burdensome and invasive surgical abortions.”
Biopharma also blasted Kacsmaryk’s decision, calling it an “act of judicial interference” in an open letter signed by more than 480 industry leaders. The preliminary injunction, the letter read, would weaken the FDA’s authority and could be used to target other approved medicines.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
