 The record $181 million settlement with Janssen, a subsidiary of
Johnson & Johnson, alleges the company improperly marketed Risperdal,
Risperdal Consta, Risperdal M-Tab and Invega, all antipsychotic
drugs. Illinois will receive $8.3 million under the agreement.In
a complaint filed Thursday, Madigan and the other attorneys general
allege Janssen engaged in unfair and deceptive practices when it
marketed Risperdal "off-label" for certain treatments and conditions
that the U.S. Food and Drug Administration has not approved.
The complaint alleges Janssen promoted Risperdal for off-label
uses to both geriatric and pediatric populations, targeting patients
with Alzheimer's disease, dementia, depression and anxiety, though
those uses were not FDA-approved and Janssen had not established
that Risperdal was safe and effective for those uses.
"Janssen falsely marketed this drug to extremely vulnerable
patients in spite of any recognized medical evidence that the drug
would be safe or effective for individuals with these conditions,"
Madigan said.
Following an extensive, four-year investigation, Janssen agreed
not only to change how it promotes and markets its antipsychotics
but also to refrain from any false, misleading or deceptive
promotion of the drugs. In addition to the record-setting payment to
the states, the settlement addresses specific concerns identified in
the investigation, including restricting Janssen from promoting its
antipsychotic drugs for off-label uses.
Additionally, over a five-year period, Janssen must:
-
Clearly and
conspicuously disclose in promotional materials for
antipsychotic drugs the specific risks identified in the
black-box warning on its product labels.
-
Present
information about effectiveness and risk in a balanced manner in
its promotional materials.
-
Not promote its
antipsychotic drugs while using selected symptoms of the
FDA-approved diagnoses unless certain disclosures are made
regarding the approved diagnoses.
[to top of second column] |
-
Require its
scientifically trained personnel, rather than 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 antipsychotics.
-
Refrain from
providing samples of its antipsychotics to health care providers
whose clinical practices are inconsistent with the FDA-approved
labeling of those antipsychotics.
-
Not use grants to
promote its antipsychotics nor condition medical education
funding on Janssen's approval of speakers or program content.
-
Contractually
require medical education providers to disclose Janssen's
financial support of their programs and any financial
relationship with faculty and speakers.
-
Implement policies to ensure that
marketing and sales personnel are not given financial incentives
that encourage or reward off-label marketing.
Joining Madigan in the settlement Thursday were attorneys general
from Alabama, Arizona, Colorado, Connecticut, Delaware, the District
of Columbia, Florida, Hawaii, Idaho, Indiana, Iowa, Kansas, Maine,
Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New
Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio,
Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota,
Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming.
[Text from file received from the office
of
Illinois Attorney General Lisa
Madigan]
 |
