The US pharmaceutical industry has called for the reversal of a judicial ruling that could withdraw regulatory approval for a common abortion drug, arguing that the judgment would diminish the authority of government agencies and put the industry at risk.

An open letter signed by more than 400 senior pharma and biotech executives strongly condemned the ruling last week by Texas federal judge Matthew Kacsmaryk, which if upheld would amount to a nationwide ban on mifepristone.

The drug is one of two commonly used to terminate pregnancies. Together, the pills account for more than half of all abortions in the US.

The letter, released on Monday and signed by executives from companies including Pfizer, Biogen and Merck, called for the reversal of Kacsmaryk’s decision, which they argued “ignores decades of scientific evidence and legal precedent” and would put “an entire industry focused on medical innovation at risk”.

Kacsmaryk ordered a preliminary injunction on regulatory approval of mifepristone, which if confirmed will take effect after a seven-day appeal period that ends on Friday. The ruling would affect access to the drug even in states with abortion protections.

The pharma executives warned that the ruling could also set a precedent for challenges to other drug approvals by the US Food and Drug Administration, plunging the pharmaceutical industry into chaos.

“Judicial activism will not stop here,” they wrote. “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 justice department filed an emergency motion on Monday asking the Fifth Circuit Court of Appeals to stay the ruling until a full appeal could be heard.

The Biden administration has said it is weighing “every option” to fight what it has described as a “reckless” ruling by Kacsmaryk, who was appointed by former president Donald Trump.

In its filing, the justice department said Kacsmaryk’s decision “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 department argued that Kacsmaryk’s “extraordinary and unprecedented” decision should be halted pending appeal, asking the court to extend the seven-day period while proceedings were resolved in the appeals court or “if necessary, the Supreme Court”. The government asked for action to be taken by Thursday.

Anti-abortion groups including the Alliance for Hippocratic Medicine had asked the federal court in Amarillo, Texas, to rescind an FDA decision in 2000 to green light mifepristone, arguing that the agency did not properly study the drug’s safety.

The US government also filed a motion on Monday in a district court in the state of Washington, which issued a conflicting decision that called on the FDA to maintain the drug’s availability just minutes after the Texas ruling. The DoJ asked the Washington court to clarify how the two orders interact and how to proceed if the Texas decision took effect.

The clashing rulings increase the prospect of the case working its way to the Supreme Court, which last year overturned Roe vs Wade, a decision that had enshrined the constitutional right to abortion for nearly five decades.

Other healthcare bodies criticised the Texas ruling, including the American Pharmacists Association (APhA), which said it added more confusion to a complicated regulatory landscape for pharmacists and patients.

“The FDA gold standard for approval has been in place for nearly 120 years,” said Ilisa BG Bernstein, interim chief executive of APhA.

“APhA and our nation’s pharmacists stand behind the FDA review and approval process that relies on evidence-based expert review to establish the safety and efficacy of marketed drugs.”


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