On August 30, 2012, Janssen Pharmaceuticals (a Johnson & Johnson company) announced that it had reached a settlement with 36 states and the District of Columbia over allegations related to promotional and marketing practices for Risperdal. The company will pay approximately $181 million to resolve claims based on state consumer protection laws. In addition, the company has entered into a Stipulated General Judgment that contains specific compliance provisions relating to the company's distribution of medical information. Specifically, the consent decree states: "Janssen Scientifically Trained Personnel shall be responsible for the identification, selection, approval and dissemination of Reprints Containing Off-Label Information regarding Atypical Antipsychotics. Neither Janssen Sales nor Janssen Marketing personnel shall disseminate these materials, unless Janssen has a pending filing with FDA for approval of the new indication described in the Reprint." The restriction placed on the dissemination of reprints is more stringent than available FDA guidance and implies support for FDA's position that off-label promotion does not have First Amendment protection as argued in several recent cases.
The consent decree also provides that only Janssen "Scientifically Trained Personnel" may respond in writing to an unsolicited request for off-label information regarding an atypical antipsychotic. "Scientifically Trained Personnel" is defined as "personnel who are highly trained experts with specialized scientific and medical knowledge, usually with an advanced scientific degree (e.g., an MD, PhD, or PharmD), whose roles involve the provision of specialized, medical or scientific information, scientific analysis and/or scientific information to health care professionals and includes Regional Medical Research Specialists, but excludes anyone performing sales, marketing, promotional ride alongs, or other commercial roles." Separately, Johnson & Johnson disclosed that it has reached an agreement in principle with DOJ regarding civil FCA matters related to sales and marketing practices, rebates, and payments for Risperdal and other drugs. Some industry experts estimate that the settlement of those matters may involve payments of approximately $2 billion. For more, see here and here.