December 9, 2023

The judge ruled that the FDA’s actions in approving mifepristone were “arbitrary and capricious” and therefore in violation of the Administrative Procedure Act, which governs federal agencies’ regulatory procedures.

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Antivaccine advocates say a federal judge’s injunction to reverse the Food and Drug Administration’s approval of the abortion pill mifepristone is a good sign for their own legal efforts. His response is just one indication of how judges may be able to roll back drug approval, thereby fundamentally disrupting the pharmaceutical industry.

“The court’s recent ruling in the abortion pill case shows why we should prevail on appeal,” said Robert Barnes, legal counsel for the antivaccine group Children’s Health Defense. organization is appealing dismissal It has filed a lawsuit challenging the FDA’s emergency-use authorization of a COVID-19 vaccine for children.

US District Court Judge for the Northern District of Texas Matthew J. Kaxmarik’s decision on mifepristone has unsettled the biopharmaceutical industry. This raises the possibility that the FDA approval process, around which drug companies organize billion-dollar drug development campaigns, may not be the final word on whether a drug can be sold in the US.

In comments on CNN over the weekend, Javier Becerra, the secretary of the Department of Health and Human Services, said “reverting the entire FDA approval process” threatens all kinds of drugs, including vaccines, insulin and Alzheimer’s disease treatments.

Vaccines that could face challenges include COVID-19 shots from Pfizer (ticker: PFE) and Moderna (mRNA), and Merck’s (MRK) human papillomavirus vaccine Gardasil.

“One can imagine for-profit corporations pulling out of the US market altogether if we had the highest standards for approval and the least amount of clarity. [marketability]says Jennifer Reich, a professor of sociology at the University of Colorado Denver who has written on vaccines.

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in his statement to Baron’sBarnes, of Children’s Health Defense, said the organization was still looking to pursue litigation with the FDA over COVID-19 vaccines. Barnes said, “We want to stand up to challenge the FDA’s actions on COVID vaccines, and the court’s recent decision in the abortion pill case shows why we should prevail on appeal to that same Fifth Circuit. “

A federal district court judge in Texas dismissed Children’s Health Defense’s case in January, saying the plaintiffs do not have standing to sue. Children’s Health Defense has said it plans to appeal to the US Court of Appeals for the Fifth Circuit, the same court to which the Justice Department appealed Judge Kaczmarić’s abortion pill decision.

It’s unclear what effect Barnes believes Kaczmarik’s decision will have on appeal in the Children’s Health Defense case. Children’s Health Defense did not respond to a request to elaborate on Barnes’ comments, and the attorney did not immediately return calls made to his office.

It’s impossible to say how successful any copycat legal effort to force the FDA to revoke approval of the vaccine might ultimately be. Much depends on how the mifepristone litigation progresses, and whether higher court judges allow Kaczmarić’s injunction to stand.

One question focuses on Kaksmarik himself. Appointed by Trump, Kaczmarik is the only federal judge in his division, which means that plaintiffs can be assured that he will oversee any cases filed there. The tendency among conservative activists and the Republican attorney general to file cases in his division has led to allegations of judge-shopping.

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So far, legal efforts have been made to stop the practice. fail,

Kaczmarić’s own views, then, can have a significant impact on whether copycat efforts are successful. “How much did the judge do here because from the judge’s point of view the abortion is charged so much that the normal rules don’t apply?” asks Dorit Reiss, professor at the University of California College of Law, San Francisco. “And how much is it because the judge feels comfortable second-guessing the FDA?”

Reiss says that while portions of Kacsmaryk’s rule in the mifepristone case are specific to abortion and irrelevant to vaccines, others can be applied more broadly. “The same thought, ‘I can second-guess what the FDA can do and how safe things are, I don’t necessarily accept the agency’s view of safety,’ he continues,” Reiss says.

In his abortion-pill decision, Kacsmaryk wrote that the FDA’s actions in approving the drug mifepristone were “arbitrary and capricious,” and therefore in violation of the Administrative Procedure Act, which governs federal agencies’ regulatory procedures. “That’s part that could be used for another drug,” Rees said.

The Children’s Health Defense has helped bring several lawsuits against Merck that claim its HPV vaccine caused injuries; Those cases have now been combined into a federal multi-district litigation. Merck did not respond to a request for comment.

In a statement, Pfizer said the FDA “reviews each drug to a high and rigorous federal standard before it can be deemed safe and effective and able to be prescribed in the United States,” and That the role of the agency is “essential” to be maintained.

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Write to Josh Nathan-Kazis at [email protected]