"Janssen Followed All Rules," Yet Has Paid Billions of $ to DOJ for Illegal Risperdal Marketing | Disease mongering | Scoop.it
From www.philly.com - January 30, 2015 4:23 PM

David Kessler, the former U.S. Food and Drug Administration commissioner, testified Wednesday that as a pediatrician, it "certainly is a red flag to me" that a Janssen Pharmaceuticals Inc. study of the use of its antipsychotic drug Risperdal in young children and adolescents, mainly boys, showed high rates of breast growth.


Kessler was FDA commissioner from 1990 to 1997, when Janssen, a subsidiary of Johnson & Johnson, received approval in 1993 for the drug to be prescribed to adults with psychosis. In the ensuing years, Janssen sought to expand the approved uses and the range of patients.


Kessler testified in Philadelphia Common Pleas Court as a witness for two Alabama parents who sued Janssen because their severely autistic son, now 20, was prescribed Risperdal for the first time when he was about 7½, without their fully knowing its risks. The boy developed breasts, a condition called gynecomastia.


Not until 2006 was Risperdal approved for use in autistic adolescents. By then, the boy had been on Risperdal for five years. Janssen sales reps had visited his pediatric neurologist, Jan Mathisen, 20 times between 2002 and 2004, bringing samples.


Testifying Monday, Mathisen said he had been the most frequent prescriber of Risperdal in Alabama. He said he would have liked to have known about the Janssen study.

"Janssen followed all rules for reporting data from clinical trials, and we believe that the prescribing information for Risperdal has been appropriate at all times," Janssen spokeswoman Robyn Reed Frenze said in a statement.


Via Pharma Guy