Drug maker to pay record-breaking $181 million to NC, 36 other states for faulty marketing, AG Cooper announces
Release date: 8/30/2012
Raleigh: Janssen Pharmaceuticals will pay North Carolina and 36 other states $181 million to resolve allegations that it improperly marketed antipsychotic drugs, the largest ever consumer protection settlement involving a drug company, Attorney General Roy Cooper announced today.
Cooper and the other AGs allege that Janssen, a subsidiary of Johnson & Johnson, engaged in unfair and deceptive practices when it marketed Risperdal, Risperdal Consta, Risperdal M-Tab and Invega (“Risperdal”) for unapproved or off-label uses. These drugs are among a class of drugs known as atypical or second generation antipsychotics.
“Marketing drugs for unapproved uses can have dangerous and sometimes deadly consequences,” Cooper said. “Drug manufacturers need to hear the message that drugs should only be marketed for conditions that they have been proven to treat.”
The $181 million settlement includes $7.1 million for consumer protection efforts in North Carolina. The record-breaking pharmaceutical settlement tops a settlement reached earlier this year where Abbott Laboratories paid $100 million to resolve allegations about the drug Depakote.
Pharmaceutical manufacturers are barred from promoting their drugs for uses not approved by the U.S. Food and Drug Administration, so called off-label uses; although physicians may prescribe drugs for those uses. Cooper and the other attorneys general claim that Janssen promoted Risperdal for off-label uses to both seniors and children, targeting patients with Alzheimer’s disease, dementia, depression, and anxiety. However, the FDA had not approved Risperdal to treat these conditions, nor had Janssen established that Risperdal was a safe and effective treatment for these conditions.
After an extensive four year investigation, Janssen agreed to change how it promotes and markets its atypical antipsychotics and also agreed to refrain from any false, misleading or deceptive promotion of the drugs.
In addition, for a five-year period, Janssen has agreed to:
- Clearly and conspicuously disclose the specific risks identified in the black-box warning on its product labels for atypical antipsychotics;
- Present balanced information about effectiveness and risk in its promotional materials;
- Not use selected symptoms of the FDA-approved diagnoses to promote its atypical antipsychotics unless certain disclosures are made;
- Require scientifically trained personnel, rather that sales and marketing personnel, to address requests for information from health care providers about Janssen’s atypical antipsychotics;
- Refrain from providing samples of atypical antipsychotics to health care providers whose practices are inconsistent with FDA-approved labeling;
- Not use grants to promote its atypical antipsychotics or only fund medical education seminars if it gets to approve speakers or programs;
- Require medical educators to disclose any financial support from Janssen and any financial relationship with faculty and speakers; and
- Ensure that marketing and sales personnel don’t get financial incentives that encourage or reward off-label marketing.
Joining North Carolina in today’s settlement are: Alabama, Arizona, Colorado, Connecticut, Delaware, District of Columbia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming.
Contact: Noelle Talley, (919) 716-6484