The pharmaceutical industry plunged into a legal confrontation Monday over the abortion pill mifepristone, issuing a torrid condemnation of a federal judge ruling that invalidated the Food and Drug Administration’s approval of the drug and called for the decision to be reversed .
The statement was signed by more than 400 leaders from some of the leading investment firms and companies in the pharmaceutical and biotech industries, none of whom make mifepristone, the first pill in the two-drug abortion regimen. It shows that the reach of this case extends far beyond abortion. Unlike Roe v. Wade and other landmark abortion lawsuits of the past, this one could challenge the basis 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 investigate the safety and efficacy of new drugs, then any drug risks having the same outcome as mifepristone,” he said. the explanation.
Also on Monday, the Justice Department filed a motion asking the U.S. Court of Appeals for the Fifth Circuit to stay the ruling of U.S. District Court Judge Matthew J. Kacsmaryk for the Northern District of Texas until the appeal of the department could be set up in the case. heard. Judge Kacsmaryk, a Trump appointee who has written critically of Roe v. Wade, delayed his ruling for just seven days to give the administration a chance to appeal.
“If enacted, the court’s order would frustrate FDA’s scientific judgment and seriously harm women, especially those for whom mifepristone is a medical or practical necessity,” said the Justice Department’s motion, which noted that mifepristone was also used in the treatment of miscarriages.
It added: “This damage would be felt across the country as mifepristone is used legally in every state. The order would undermine healthcare systems and the dependency interests of corporations and medical providers.”
The appeals court gave the plaintiffs, a coalition of anti-abortion groups and doctors, until midnight Tuesday to file a response.
Plaintiffs’ attorney Erin Hawley said in a statement Monday: “Chemical abortion drugs provide no therapeutic benefit — they can cause serious and life-threatening complications for the mother, in addition to ending a baby’s life.”
She added that “the FDA has put women at risk and the agency should be held accountable for its reckless actions.”
Also on 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 challenging the agency’s additional restrictions on the drug, produced a contradictory injunction less than an hour after the Texas ruling, issued Friday night. .
Judge Thomas O. Rice, an Obama appointee, did not lift the additional restrictions, but told the FDA not to do anything to limit current access to mifepristone in the jurisdictions that filed the lawsuit, which represent a majority of the states where abortion remains legal.
In its motion in that case, the Justice Department said there was “considerable tension” between the Texas and Washington rulings and asked Judge Rice to clarify what the FDA would have to do if the Texas ruling were to take effect — essentially seeking instructions from the judge that would allow the agency to continue to keep mifepristone available.
The dueling rulings of two federal judges have led to a legal confrontation that will likely end in the Supreme Court.
“This is absolutely a test of our justice 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 to sign a letter in support of the FDA in the Texas case in both district court and appeals court Monday.
Mr Weiser said the Texas decision violated “basic principles” about “how you base judgments on evidence and about agency authority.” He added: “The challenge is that once you start undermining those rules in one case, you undermine it for others.”
The greater destabilizing potential of the Texas ruling was at the root of the letter signed by biotech and pharmaceutical executives.
Dr. Jeremy Levin, the CEO of Ovid Therapeutics and the former president of BIO, a biotech trade association, said in an interview that he and a few other industry leaders have been concerned about the Texas lawsuit since it was first filed in November. “It completely turns the FDA’s authority on its head,” said Dr. Levin on Judge Kacsmaryk’s ruling. “And then, more importantly, it opens it up to a political determination of what a drug is or isn’t, and that’s very detrimental to vaccines, Alzheimer’s drugs, everyone else.”
Dr. Shehnaaz Suliman, the chief executive of ReCode Therapeutics, said she and Dr. Amanda Banks, the former chief executive of Blackfynn Therapeutics, began drafting the letter a few weeks ago, following a March 15 hearing in the case in Judge Kacsmaryk’s court in Amarillo, Tex.
“The main message is the concern about the court’s reach and how it might apply to other areas of disease or products regulated by the FDA,” said Dr. Suliman, who was involved in organizing a “call to action” among industry members in response to the Supreme Court’s decision last year to overturn Roe v. Wade.
“The FDA evaluation of product safety and effectiveness is the gold standard in the world,” she said, “and our industry relies on it to drive the kind of innovation that has resulted in medicines that have saved millions.”
On Friday night, after the ruling was made, Dr. Suliman and Dr. Banks their design with Dr. Levin and three other executives, and had virtual meetings to fine-tune it. Then “Dr. Banks and others pulled through all night,” said Dr. Levin, who worked Friday night through Saturday to finish it off.
The group emailed the draft to about 100 industry leaders, many of whom signed it and also distributed it to their employees and other industry executives, said Dr. Levin. Asked if anyone refused to sign, he said: “In our experience, people don’t refuse — they just don’t respond.”
Most signatories are not concerned with reproductive health. One signatory, Pfizer, makes a small percentage of the US supply of the second drug in the drug-abortion regimen, misoprostol, which is approved for other medical conditions but used off-label for abortion.
A spokeswoman for Pfizer said the company did not support off-label use of any of its drugs, but that the FDA “plays a critical role in the U.S. public health system by bringing new drugs to patients and conducting ongoing safety reviews that assess the continued use of them – that should be maintained.
Legal scholars said the Texas ruling appeared to be the first time a court had attempted to invalidate a drug’s approval over an FDA objection. For decades, Congress has empowered the agency to determine whether drugs are safe and effective.
The ruling could be so drastic for drug companies that the letter from industry leaders is likely just the beginning of industry actions to oppose it, said Jennifer Oliva, a law professor at the University of California College of the Law, San Francisco. , who signed a letter submitted to Judge Kacsmaryk’s court by drug policy scholars in support of the FDA
“They are going to heavily lobby the state legislatures, Congress and get involved in the courts in this battle going forward because it threatens their livelihoods,” Ms. Oliva said.
