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08/30/2012

CT Joins 181 Million Settlement With Janssen Pharmaceuticals

For immediate release                                                                   THURSDAY AUG. 30, 2012

 

HARTFORD -- Attorney General George Jepsen and state Department of Consumer Protection Commissioner William Rubenstein announced today that Connecticut has joined a $181 million dollar settlement agreement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson.

 

Thirty-three other states and the District of Columbia also are participating in the agreement, the largest multi-state consumer protection settlement with a pharmaceutical company. It follows an extensive, four-year investigation and stems from allegations that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.

 

Connecticut’s share of the settlement is $3,539,549. Approximately $3.1 million will be paid into the General Fund; the remainder will be paid into the OAG and DCP consumer funds and the DCP’s prescription-drug monitoring program.

 

The complaint alleges that Janssen promoted Risperdal for off-label use to treat Alzheimer’s disease, dementia, depression, and anxiety, even though the U.S. Food and Drug Administration had not approved the drug for these purposes, nor had Janssen shown that Risperdal was safe and effective in treatment of these conditions.

 

“The law prohibits off-label marketing for a reason: to protect the health and safety of consumers. This settlement will require this company to follow the law and end the practice of off-label marketing for these drugs,”  Attorney General Jepsen said.

 

"This is an appropriate settlement that will presumably send a message throughout the marketplace that promoting medications for off-label use is off-limits for drug companies," Consumer Protection Commissioner William Rubenstein said.

 

The states alleged that Janssen’s marketing of Risperdal, among a class of drugs known as atypical or second-generation antipsychotics, for unapproved or off-label uses violated the law as an unfair and deceptive practice.

 

Federal law prohibits pharmaceutical manufacturers from promoting their products for off-label uses, although physicians may prescribe drugs for those uses.

 

As part of the settlement, Janssen has agreed to change not only how it promotes and markets its atypical antipsychotics, but the company also agreed to refrain from any false, misleading or deceptive promotion of the drugs.

 

Additionally, for a five-year period, Janssen:

  • Must clearly and conspicuously disclose the specific risks identified in the black-box warning on its product labels in promotional materials for atypical antipsychotics;
  • Must present balanced information about effectiveness and risk in promotional materials;
  • Shall not promote its atypical antipsychotics using selected symptoms. Instead the company can only promote using FDA-approved indicated use.
  • Shall require its scientifically trained personnel, rather that its sales and marketing personnel, to develop the medical content of scientific communications to address requests for information from health care providers regarding Janssen’s atypical antipsychotics;
  • Must refrain from  providing samples of its atypical antipsychotics to health care providers whose clinical practices are inconsistent with the FDA-approved labeling of those atypical antipsychotics;
  • Must not use grants to promote its atypical antipsychotics nor condition medical education funding on Janssen’s approval of speakers or program content;
  • Must contractually require medical education providers to disclose Janssen’s financial support of their programs and any financial relationship with faculty and speakers; and
  • Must have policies in place to ensure that financial incentives are not given to marketing and sales personnel that encourage or reward off-label marketing.

 

Assistant Attorney General Thomas Saadi handled this matter for the Attorney General with Assistant Attorney General Phillip Rosario, head of the Consumer Protection unit.

 

View complaint: http://www.ct.gov/ag/lib/ag/press_releases/2012/20120830_janssencomplaint.pdf

 

 

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