PhRMA and congressional Democrats file briefs to reverse court ruling on mifepristone

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The Pharmaceutical Research and Manufacturers of America has waded into the mifepristone controversy by filing an amicus brief – along with other industry stakeholders – asking for a reversal of a lower court decision in Alliance for Hippocratic Medicine v. the U.S. Food and Drug Administration.

More than 250 congressional Democrats have also filed a brief urging an appeals court to reverse the lower court decision in Texas.

Both cite as a reason the implications of a court overriding drug decisions by the FDA. 

The U.S. Court of Appeals for the Fifth Circuit in New Orleans is set to hear arguments on May 17. A decision could return the case back to the Supreme Court.

WHY THIS MATTERS

For PhRMA, the Advanced Medical Technology Association, Consumer Healthcare Products Association and the National Association of Manufacturers, the decision by the district court is a threat to future FDA drug approval.

"It is wrong for any court to replace the FDA's expert scientific decision embodied in a drug approval with its own judgment. The FDA is authorized by Congress to evaluate the safety and efficacy of medicines – and the agency is the gold standard for regulatory review. The district court's ruling would upend the successful regulatory framework on which biopharmaceutical research and development depends," said PhRMA executive vice president, general counsel and corporate secretary Jim Stansel.
 
In the brief, PhRMA said the district court erred in replacing FDA's scientific judgments with its own views and further overstepped by imposing additional requirements not found in the statute. Specifically, the district court required that a medicine's approved use conditions must match the supporting clinical trial conditions, and that a controlled clinical study and extra adverse event reporting must support modifications to Risk Evaluation and Mitigation Strategies (REMS). 

"Importantly, Congress did not impose these requirements and for good reason: they run contrary to well-understood and accepted scientific methods and FDA's proper use of its expertise," PhRMA said.  

Secondly, the district court decision jeopardizes the certainty long afforded by FDA approval, PhRMA said. 

"The district court's ruling makes it possible – if not probable – that any FDA approval decision for a medicine could be subject to unwarranted challenge in court," PhRMa said. "Under the district court's reasoning, any healthcare provider could bring a lawsuit challenging any drug approval at any time, and a court could invalidate the approval without providing drugmakers the notice and hearing required by Congress as part of any suspension or withdrawal of an FDA approved drug."   
 
The district court's order strikes a blow to Congress's regulatory framework and the investments that hinge upon it, PhRMA said. 
 
"In short, the district court's ruling is deeply flawed and would jeopardize biopharmaceutical innovation," it said. 
 
The brief from the congressional Democrats said, "Amici believe that the district court's stay of the U.S. Food and Drug Administration's September 28, 2000 approval of mifepristone and other challenged agency actions has no basis in law, threatens the Congressionally mandated drug approval process, and poses a serious health risk to pregnant individuals by making abortion more difficult to access--when access has already been seriously eroded in the aftermath of Dobbs v. Jackson Women's Health Organization."

They asked for a reversal, saying the Texas court's decision could threaten access to other medications that have been approved by FDA.

In June, the Supreme Court overturned Roe v. Wade and Dobb's v. Jackson Women's Health Organization, rulings that upheld a woman's right to an abortion.

THE LARGER TREND

On Friday, April 21, the Supreme Court stayed the U.S. District Court for the Northern District of Texas's order blocking the FDA's approval of mifepristone.

In the order, the Supreme Court allowed the abortion pill to remain available while the case moves forward. 

The justices granted emergency requests by the Justice Department and the pill's manufacturer Danco Laboratories to put on hold an April 7 preliminary injunction issued by U.S. District Judge Matthew Kacsmaryk in Texas, blocking FDA approval of mifepristone, according to Reuters.

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org