LG: NY Joins 'Off Label' Marketing Drug Settlement

‘Deceptive Marketing’ Claims Yield $161 Mill. Settlement

by ROBERTO X. CRUZ Legislative Gazette  September 10, 2012

New York State Attorney General's Eric Schneiderman's push for consumer protection from deceptive marketing is paying off-in the form of $161 million.

The Attorney General's office announced on Aug. 30 a record resolution with Janssen Pharmaceutical, a subsidiary company of pharmaceutical giant Johnson and Johnson, in the largest multi-state financial payout for a pharmaceutical company in history. The formal complaint filed in New York State County Supreme Court charged Janssen with improperly marketing and advertising anti-psychotic medications including Risperdal and Invega for uses not approved by the U.S. Food and Drug Administration from 1998 to 2004. 

New York will receive $9 million from the settlement. The remainder is to be shared between 36 other states and the District of Columbia. 

Janssen is also prohibited from marketing any of their drugs for "off-label" uses in the future. 

Among the unapproved uses cited in the complaint are the treatment of dementia in elderly patients, depression, and anxiety, and obsessive compulsive disorder, conduct disorder in children with autism, post-traumatic stress disorder and Alzheimer's disease. Risperdal and Invega are often used to treat schizophrenia and bipolar mania. 

The precedent set by the Attorney General's complaint sends a strong message to pharmaceutical companies looking to repurpose their drugs.

"This landmark settlement holds the companies accountable for practices that put patients in danger and serves as a warning to other pharmaceutical giants that they must play by one set of rules," Schneiderman said. "People should be able to trust their doctor's advice without fear that drug companies are manipulating their physician's independent judgment." 

In a statement released by Janssen, the company admits to no wrong doing or any law breaking, and made it clear all parties involved acknowledge the restitution is neither a fine nor penalty. 

Harvey Rosenthal, the executive director of the New York Association of Psychiatrist Rehabilitation, said the efforts by state attorneys general, including Schneiderman, to ensure medications are accurately and honestly presented to both the prescriber and patients is necessary to protect their health and ability to make informed choices.

"This settlement underscores the critical importance of insuring that New Yorkers are taking the right psychiatric medication for the right and approved purpose," Rosenthal said.

This settlement also prohibits Janssen from awarding grants to health care professionals based on the number of prescriptions they write, an allegation company spokesperson Theresa Mueller denies ever happened.

"Our company strongly disagrees with many of the allegations and the characterizations of the evidence in the state's complaints," said Mueller. "We take our obligation to ensure the safe and appropriate use of our medications very seriously."

Janssen will no longer be allowed to promote their drugs to treat individual symptoms. They will also be required to provide accurate and objective responses to requests for all off-label uses by doctors. 

In March 2002, the FDA-approved indication of Risperdal was changed to include the treatment of schizophrenia, and in December 2003, the label was expanded to include the short-term treatment of acute manic or mixed episodes associated with bipolar disorder