Federal judge lets Nevada company intervene in abortion pill case

Mifepristone tablets are seen in a Planned Parenthood clinic Thursday, July 18, 2024, in Ames, Iowa. Photo by: Charlie Neibergall / AP, file

The Nevada-based manufacturer of mifepristone, one half of the generic abortion pill regimen, will be allowed to intervene in a court case challenging the Food and Drug Administration’s approval of the drug and limiting the use of the name brand version, a federal judge in Texas ruled this week.

While Missouri, Kansas and Idaho’s attorneys general argue that the FDA was wrong to continuously relax requirements for the drug since 2016, GenBioPro CEO Evan Masingill wrote in a statement to the Sun that its safety was “backed by more than a quarter-century of rigorous scientific research.”

On Monday, U.S. District Judge Matthew Kacsmaryk granted GenBioPro “permissive intervention,” writing that the company’s filings were timely and that their involvement wouldn’t delay the case.

“We welcome the court’s order,” Masingill said. “This ongoing case is nothing but an extremist attempt to interfere with the FDA’s regulatory authority and to restrict access to essential care.”

The case has been a game of musical chairs, most notably having the original plaintiffs — a group of anti-abortion medical professionals with the Alliance for Hippocratic Medicine — swap themselves out after the Supreme Court decided they lacked standing in June.

Danco Laboratories, which distributes the name brand drug Mifeprex, and the FDA are also defendants in the case.

Just like it did with the alliance, Masingill wants to see the court dismiss the attorneys generals’ case, calling it “baseless.”

“GenBioPro remains steadfast in its commitment to protect the rights of patients and providers nationwide, and we will use our legal tools to defend access to mifepristone and uphold the integrity of the FDA’s approval process,” he added.

The FDA may not stay on GenBioPro’s side for long. New Health and Human Services Secretary Robert F. Kennedy Jr. said at his confirmation hearing that President Donald Trump asked him to look into the drug’s “safety issues.”

In a request to push back a court deadline, the FDA’s legal team said it would use the time to “ensure that the new administration … is able to familiarize themselves with the issues in this case.” The administration’s next reply is due Monday.

In U.S. trials, mifepristone resulted in a successful abortion over 97% of the time, according to the FDA.

“It is incredibly clear that mifepristone is a safe medication,” reproductive epidemiologist Dr. Laura Schummers previously told the Sun. “There have been many studies already on the safety and efficacy of mifepristone.”