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FDA Berated Over Inaction on Antipsychotic

PHILADELPHIA (CN) - Regulators failed to act on signs that the popular antipsychotic Risperdal causes teenage boys to grow breasts, a federal complaint from the law firm Sheller PC alleges.

Sheller notes in the Jan. 29 action that it represents hundreds of children suing Johnson & Johnson and its subsidiary Janssen in Pennsylvania over serious side effects attributed to the use of Risperdal, or its generic versions, as well as the newer schizophrenia treatment Invega.

Claiming that the drugs can cause adolescent males to grow abnormal breasts, a condition known as gynecomastia, and other adverse effects on sexual maturation, the law firm says it petitioned the Food and Drug Administration in 2012 to remove the pediatric approval of Risperdal or apply a black-box warning about on the drugs.

Sheller notes that, during the course of its representation of consumers suing the makers of Risperdal, it acquired certain confidential documents that establish the drug's danger.

It allegedly cannot produce these documents to the FDA, however, "because they are subject to confidentiality and protective orders in those cases."

Sheller said its citizen petition to the FDA implored the agency to obtain those confidential documents directly from Johnson & Johnson and Janssen, or to have the drugmakers release Sheller from the confidentiality orders.

The firm wanted the FDA to hold a hearing in 2013 on the confidential documents, but the agency shot down that request in June 2013.

Sheller said the answer "fundamentally" misunderstood the relief that the firm requested since "the FDA invited Sheller to submit the Confidential Documents to the FDA by filing them on the public docket."

In November 2014, after having never given Sheller a reason about why it would not provide a hearing, the FDA denied the petition for removal of pediatric indication or a black-box warning.

Sheller says the FDA's arbitrary actions amount to a violation of the Administrative Procedures Act.

It wants a federal judge to issue one injunction that either revokes the pediatric indication of Risperdal or requires the addition of a black-box warning to the drug's labeling. The firm wants another injunction granting it relief with respect to the confidential documents.

Sheller notes that side effects associated with Risperdal cause pediatric patients to "avoid peers, miss school and forego social opportunities."

"Having to change clothes for gym class becomes a regularly schedule torture session," the complaint says.

The sealed documents "describe the risks associated with the Risperdal Drugs and contradict, complicate, and/or substantially call into question safety data provided by J&J and/or Janssen to the FDA," Sheller says. "The documents are in J&J and/or Janssen's possession and control, and in many instances were generated by J&J, Janssen and/or J&J's predecessor or subsidiary companies."

Risperdal was approved in 2006 for treatment of schizophrenia and bipolar disorder in children and adolescents.

In a November 2013 guilty plea, Janssen agreed to pay the Justice Department more than $2.2 billion over its promotion of Risperdal, Invega and another prescription drug, Natrecor, for uses not approved as safe and effective by the FDA.

Of that amount, $1.391 billion resolved Risperdal-Invega claims, Sheller notes, adding that the drugmaker also faced a $400 million criminal fine.

Johnson and Johnson and Janssen also paid $327 million to South Carolina 2011, and $158 million to Texas, Sheller says.

The firm is represented in it federal action by Robert Palumbos and Andrew Sperl of Duane Morris.

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