By Dave Andrusko
On Monday, less than one business day after Judge J. Kacsmaryk’s decision to suspend FDA approval of mifepristone landed, the Justice Department asked the 5th Circuit Court of Appeals to keep the drug on the market until the appeal is decided.
On Friday, Judge Kacsmaryk said his ruling would not take effect until this Friday. This gives the Biden administration time to appeal before the drug could be pulled from the market.
The judge’s ruling, Justice Department lawyers said, “upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.” The Washington Post reported
The government and the drug manufacturer, Danco Laboratories, asked the appeals court to issue its decision on pausing Kacsmaryk’s order by noon Thursday. In a brief order late Monday afternoon, the 5th Circuit asked the groups challenging mifepristone’s approval to file their response by midnight Tuesday.
If the appeals court does not pause Kacsmaryk’s order while the appeal is decided — or is slow in making that decision — the Justice Department could go directly to the U.S. Supreme Court in an effort to keep mifepristone available for women seeking to terminate pregnancies. The high court will almost certainly hear the case eventually, either before or after the 5th Circuit rules.
In their 47 page brief they argued that the challengers had no right to file the lawsuit since they were not personally harmed by the abortion pill. As it happens, Judge Kacsmaryk spent a lot of time explaining exactly why the plaintiffs do have standing.
The lawsuit was brought by the Alliance Defending Freedom on behalf of pro-life medical organizations and four doctors who say they have treated women with mifepristone. Judge Kacsmaryk held “that both the initial approval of the pills in 2000 as well as more recent FDA decisions allowing them to be prescribed via telemedicine, sent by mail and dispensed at retail pharmacies, are unlawful,” Politico’s Alice Miranda Ollstein wrote.
Meanwhile, in a separate case regarding the status of the FDA’s approval of mifepristone, Judge Thomas Rice of Washington’s Eastern Federal District Court “granted the preliminary injunction requested by the plaintiffs, made up of Democratic attorneys general, and prevents the FDA from ‘altering the status quo and rights as it relates to the availability of mifepristone,’” ABC News reported.
Ultimately, “Rice did not order the FDA to roll back any of its restrictions of mifepristone in his Friday ruling, but he ruled that the status quo must remain” in the 17 states and the District of Columbia which filed the second lawsuit, Ann E. Marimow, Caroline Kitchener Perry Stein, and Robert Barnes wrote for The Washington Post.