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  • Writer's pictureThe San Juan Daily Star

Drug company leaders condemn ruling invalidating FDA approval of abortion pill

Senior executives of more than 400 pharmaceutical and biotech companies and investment firms on Monday, April 10, 2023, issued a scorching condemnation of a ruling by a federal judge that invalidated the FDA’s 23-year-old approval of the abortion pill mifepristone, and they called for the decision to be reversed.

By Pam Belluck and Christina Jewett

The pharmaceutical industry earlier this week plunged into a legal showdown over the abortion pill mifepristone, 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 United States.

“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,” the statement said.

Also Monday, the Justice Department filed a motion asking the 5th U.S. Circuit Court of Appeals to stay the ruling by Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas until the department’s appeal of the case could be heard. Kacsmaryk, a Donald 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 Tuesday to file a response.

A lawyer for the plaintiffs, Erin Hawley, said in a statement 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.”

Also Monday, the Justice Department 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 Friday evening.

Judge Thomas Rice, a Barack 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 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 dueling rulings by two federal judges have set up a legal showdown that is likely to end up in the Supreme Court.

“This is absolutely a test of our legal system’s ability to function,” Colorado Attorney General Phil Weiser said in an interview. Colorado is a plaintiff in the Washington case and one of nearly two dozen states that signed briefs supporting the FDA in the Texas case before both the district court and, on Monday, before the appellate court.

Weiser said the Texas decision violated “basic principles” about “how you make judgments based on evidence and about the authority of agencies.” He added, “The challenge is, once you start undermining those rules in one case, you undermine it for others as well.”

The larger destabilizing potential of the Texas ruling was at the root of the letter signed by the biotech and pharmaceutical executives.

Dr. Jeremy Levin, CEO of Ovid Therapeutics and former chair of BIO, a biotech trade association, said in an interview that he and a few other industry leaders had been worried about the Texas lawsuit since it was filed in November. “It completely upends the FDA’s authority,” Levin said of Kacsmaryk’s ruling. “And then, much more importantly, it opens it up to a political determination of what a medicine is or isn’t, and that is deeply harmful for vaccines, Alzheimer’s drugs, all the others.”

Legal scholars said the Texas ruling appeared to be the first time a court had tried to invalidate the approval of a drug over the objection of the FDA. For decades, Congress has given the agency authority to determine whether drugs are safe and effective.

The ruling could be so far-reaching for pharmaceutical companies that the letter from industry leaders is probably just the beginning of the industry’s actions to oppose it, said Jennifer Oliva, a professor of law at the University of California College of the Law, San Francisco, who signed a brief submitted to Kacsmaryk’s court by drug policy scholars in support of the FDA.

“They’re going to heavily lobby state legislatures, Congress and get involved in the courts in these battles going forward because it threatens their livelihood,” Oliva said.

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