Former FDA chief calls J&J misleading on Risperdal

Former U.S. Food and Drug Administration Commissioner David Kessler said Friday in Philadelphia that Johnson & Johnson officials were "at best" misleading when they told the FDA in 2005 that there was no correlation between the drug Risperdal and higher levels of breast growth in adolescent boys.

It was Kessler's third day testifying for the plaintiffs, a mother and father from Alabama, who sued J&J and its Janssen Pharmaceuticals subsidiary in Philadelphia Common Pleas Court because their severely autistic son developed breasts after taking the antipsychotic drug from 2002 through 2007. The couple argues that J&J failed to adequately warn of the risk of the condition, gynecomastia.

"I'm just having a hard time right now, hearing what the pharmaceutical company was doing," the mother, Benita Pledger, said Thursday evening outside the courtroom.

"Janssen appropriately analyzed and reported data from clinical trials," spokeswoman Robyn Reed Frenze said in a statement Thursday evening.

On Friday, J&J attorney Diane Sullivan began cross-examining Kessler, but only after Judge Ramy Djerassi denied her request to strike all of Kessler's testimony.

Sullivan questioned Kessler about other drug companies he had testified against since leaving the FDA in 1997, and pointed to places in reports, letters, and company e-mails where Janssen officials mentioned gynecomastia.

Before the FDA expanded the approval of Rispderal in 2006 for use in adolescents with autism behavior disorders, Sullivan said, the FDA denied Janssen's request to include dosing information for children.

Kessler said the FDA was correct to do so, as dosing information would be a backdoor approval of the drug for use in children without the required studies. "There is nothing that prevents you from disclosing safety information," Kessler said.

Djerassi did not rule on Sullivan's request to question Kessler about the FDA's having disagreed with him in a 2013 Risperdal matter, but the judge warned her that the tactic carried risk.

"You will open the door to how the government views J&J on this drug in the last few years," Djerassi said. In 2013, J&J agreed to a $2.2 billion settlement over criminal and civil allegations it promoted Risperdal and other drugs for unapproved uses.


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