R.I. to receive $2.67M from Janssen settlement

By Emily Greenhalgh
PBN Web Editor
Twitter: @EGreenhalgh

PROVIDENCE – Rhode Island will receive $2.67 million as part of a $200 million settlement with Johnson & Johnson subsidiary, Janssen Pharmaceuticals Inc., Attorney General Peter F. Kilmartin announced Thursday.

The $200 million marks the largest-ever multi-state consumer protection settlement with a pharmaceutical company. Kilmartin worked with 37 other Attorneys General nationwide on the lawsuit.

In Rhode Island’s complaint, Kilmartin alleged that Janssen improperly marketed its antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.

The complaint, which was filed Thursday in Providence County Superior Court with the settlement, alleges that Janssen engaged in “unfair and deceptive practices when it marketing Risperdal for unapproved or off-label uses.”

Risperdal is among a class of drugs known as atypical or second generation antipsychotics.

“The public has a right to expect that the representations made by pharmaceutical companies be truthful and accurate,” Kilmartin said in prepared remarks. “Our office will continue to hold drug companies accountable when they put profits ahead of patients’ health.”

“This historic settlement is a major milestone in our continued efforts to root out healthcare fraud, and it sends a clear warning that the marketing and sales of drugs for unapproved, off-label uses will not be tolerated,” added Kilmartin.

The settlement comes after what a release referred to as an “extensive four-year investigation.” Janssen has agreed to change how it promotes and market atypical antipsychotics as well as to refrain from any false, misleading or deceptive promotion of the drugs.

In addition to the record setting payment, the settlement restricts Janssen from promoting its atypical antipsychotic drugs for “off-label” unapproved by the U.S. Food and Drug Administration.

For a five-year period, Janssen:

• Must clearly and conspicuously disclose, in promotional materials for atypical antipsychotic products, the specific risks identified in the black-box warning on its product labels

• Must present information about effectiveness and risk in a balanced manner in its promotional materials

• Shall not promote its atypical antipsychotics using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses

• 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.

Thus far in 2012, Rhode Island has received more than $12.6 million as a result of multi-state consumer protection settlements.