After a decade-long investigation, Johnson & Johnson has agreed to settle civil and criminal claims relating to marketing tactics for three of the drugs promoted by its subsidiaries.
The U.S. Department of Justice announced in early November that Johnson & Johnson agreed to pay more than $2.2 billion to resolve the ongoing investigations. The company will also plead guilty to a misdemeanor. The allegations include off-label marketing and kickbacks to doctors and pharmacists for the drugs Risperdal, Invega, and Natrecor.
Johnson & Johnson’s subsidiary Janssen engaged in an aggressive campaign to promote the antipsychotic drug Risperdal for uses not approved by the U.S. Food and Drug Administration (FDA).
For most of the time period of 1999 to 2005, Risperdal was approved only to treat schizophrenia. Janssen’s sales representatives allegedly promoted Risperdal to doctors and other prescribers for elderly dementia patients to treat symptoms including anxiety, agitation, and depression. The company went so far as to create written sales scripts for their sales agents that minimized any mention of the actual FDA-approved use. The company also provided incentives for its sales team for off-label promotion and basing their bonuses on total sales of Risperdal, including for non-FDA-approved uses.
The U.S. Department of Justice press release also alleged that “J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks.”
The FDA had repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.” In a plea agreement, Janssen admitted to promotion of the drug for elderly patients without schizophrenia. The complaint also alleges that Janssen marketed Risperdal children and people with mental disabilities.
The government alleged, “J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production.”
The press release states, “Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.”
Charges also claimed that Janssen promoted the newer antipsychotic drug Invega for off-label indications, and made false and misleading statements about Invega’s safety and efficacy.
The suits also alleged that the company paid kickbacks to doctors who prescribed Risperdal. The complaint states that Janssen paid speaker fees to doctors to encourage them to write Risperdal prescriptions. Sales reps allegedly told the doctors that if they wanted to receive money for speaking, they had to increase their Risperdal prescriptions.
The civil settlement also resolves allegations that J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. Omnicare is the largest long-term care pharmacy provider, and Janssen was actively promoting the use of Risperdal into nursing homes.
The government also charged that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor. The government alleges that the company had “no sound scientific evidence supporting the medical necessity” of off-label uses it promoted.
According to the U.S. Department of Justice press release, this is “one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.”
U. S. Attorney General Eric Holder went so far as to say that Johnson & Johnson “displayed a reckless indifference to the safety of the American people.” These words may shock some, who have come to know Johnson & Johnson as the promoter and provider of baby shampoo and other family-friendly products.
In addition to the criminal and civil resolutions, J&J was forced to agree to a five-year “probation” period. During this time, it will operate under a Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General. The agreement requires J&J to implement major changes to the way its pharmaceutical affiliates do business.