The pharmaceutical industry plunged into a legal showdown over the abortion pill mifepristone on Monday, issuing a scorching condemnation of a ruling by a federal judge that invalidated the Food and Drug Administration’s approval of the drug and calling for the decision to be reversed.
The statement was signed by more than 400 leaders of some of the drug and biotech industry’s most prominent investment firms and companies, none of which make mifepristone, the first pill in the two-drug medication abortion regimen. It shows that the reach of this case stretches far beyond abortion. Unlike Roe v. Wade and other past landmark abortion lawsuits, this one could challenge the foundation of the regulatory system for all medicines in the US.
“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” said the statement.
Also on Monday, the justice department filed a motion asking the US Court of Appeals for the Fifth Circuit to stay the ruling by Judge Matthew J. Kacsmaryk of the US District Court for the Northern District of Texas until the department’s appeal of the case could be heard. Judge Kacsmaryk, a Trump appointee who has written critically of Roe v. Wade, had issued only a seven-day stay of his ruling to allow the government a chance to appeal.
“If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” said the justice department motion, which noted that mifepristone was also used in treating miscarriages.
It added: “This harm would be felt throughout the country, given that mifepristone has lawful uses in every state. The order would undermine health care systems and the reliance interests of businesses and medical providers.”
The appeals court gave the plaintiffs, a coalition of groups and doctors who oppose abortion, until midnight on Tuesday to file a response.
A lawyer for the plaintiffs, Erin Hawley, said in a statement on Monday, “Chemical abortion drugs don’t provide a therapeutic benefit — they can cause serious and life-threatening complications to the mother, in addition to ending a baby’s life.”
She added that “the FDA put women in harm’s way, and the agency should be held accountable for its reckless actions.”
The justice department also filed a motion in a separate lawsuit over mifepristone. That case, filed in Washington state against the FDA by 18 Democratic attorneys general who challenged extra restrictions that the agency imposes on the drug, produced a contradictory order less than an hour after the Texas ruling, which was issued on Friday evening.
Judge Thomas O. Rice, an Obama appointee, did not lift the extra restrictions but told the FDA not to do anything to limit current access to mifepristone in the jurisdictions that had filed the suit, which represent a majority of the states where abortion remains legal.
In its motion in that case, the justice department said there was “significant tension” between the Texas and Washington rulings and asked Judge Rice to clarify what the FDA would be obligated to do if the Texas ruling took effect — essentially seeking instructions from the judge that would allow the agency to continue to keep mifepristone available.
The duelling rulings by two judges have set up a legal showdown that is likely to end up in the Supreme Court.
New York Times News Service
