Pharma executives condemn decision overturning FDA approval of abortion pill

More than 400 executives said the decision ignores both scientific and legal precedents and that, if upheld, it would create uncertainty for the pharmaceutical and biotechnology industries.

The pharmaceutical industry plunged into a legal confrontation on Monday over the abortion pill mifepristone, condemning in a manner virulent a ruling by a federal judge that overturned the Food and Drug Administration's decision approving the drug and calling for the decision to be reversed.

The The statement was signed by more than 400 executives of some of the most prominent pharmaceutical and biotech investment firms and companies, none of which manufacture mifepristone, the first pill in the two-drug abortion regimen. This shows that the scope of this case extends far beyond abortion. Unlike Roe v. Wade and other landmark abortion lawsuits, this one could challenge the foundation of the regulatory system for all drugs in the United States.

"If courts can overturn drug approvals without regard to science or evidence, or the complexity required to fully verify the safety and efficacy of new drugs, any drug risks having the same outcome as mifepristone,” the statement read.

Also Monday, the Justice Department filed a motion asking the United States Court of Appeals for the Fifth Circuit to stay the decision of Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas until the department's appeal of the case can be heard. Judge Kacsmaryk, a Trump appointee who criticized Roe v. Wade, had only granted a seven-day reprieve from his decision to allow the government to appeal.

"If allowed to take effect, the court order would thwart the scientific judgment of the FDA and seriously harm women, especially those for whom mifepristone is a medical or practical necessity," said the Justice Department's petition, which noted that mifepristone was also used. in treating miscarriages.

He added, "This harm would be felt nationwide, given that mifepristone has legal uses in all states. healthcare and dependency interests of corporations and healthcare providers until midnight Tuesday to file a response.

Plaintiffs' attorney Erin Hawley, said in a statement on Monday: "Chemical abortifacient drugs provide no therapeutic benefit – they can cause serious and life-threatening complications for the mother, in addition to ending a baby's life. put women at risk, and the agency should be held accountable for its reckless actions. This case, filed in Washington State against the F.D.A. by 18 Democratic attorneys general who challenged the agency's additional drug restrictions, filed a contradictory order less than an hour after Texas' decision, released Friday night.

Judge Thomas O. Rice, an Obama appointee, did not lift the additional restrictions but told the F.D.A. to do nothing to limit current access to mifepristone in the jurisdictions that filed the complaint, which represent the majority of states where abortion remains legal.

In its motion in the case, the Justice Department said there was "significant tension" between the Texas and Washington rulings and asked Judge Rice to clarify what the F.D.A. would be forced to do if the Texas decision took effect - essentially seeking instructions from the judge that would allow the agency to continue to keep mifepristone available.

The decisions in duel by two federal judges have set up a legal showdown that will likely end in the Supreme Court.

"This is absolutely a test of our system's ability legal to operate," Phil Weiser, Colorado's attorney general, said in an interview. Colorado is a plaintiff in Washington's case and one of nearly two dozen states that have signed briefs supporting...