1. What would you do if you were a pharmaceutical sales rep and were told to promote a drug for off-label use? What protections and incentives are available under the Federal False Claim Act to encourage employees to report illegal behavior?
2. What traits and behaviors should an ethical salesperson possess? What role does the sales manager play in ethical selling behavior?
Johnson & Johnson agreed to a $2.2-billion settlement over the marketing of its antipsychotic drug Risperdal. Pfizer agreed to a $2.3-billion settlement and Eli Lilly paid $1.4 billion to settle disputes with the U.S. government. Glaxo recently agreed to a $3-million settlement-its fourth settlement with the government over the marketing of its products. By law, pharmaceutical companies are allowed to market their drugs only for uses approved by the Food and Drug Administration (FDA), but doctors may prescribe any approved drug as they see fit. Drug manufacturers have been training their sales forces to educate doctors on nonapproved uses and dosages, called "off-label" marketing. Almost 75 percent of the largest pharmaceutical settlements with the government are for off-label marketing. Glaxo even went so far as to have a questionable article ghost-written by a company and later published in a medical journal under the names of academic authors to convince doctors that Paxil was proven effective in treating depression in children, a use that the FDA has not approved. The reported clinical trial was later criticized by the medical community, but doctors probably are not aware of that because a majority of them rely on pharmaceutical companies for information on drugs. Most unlawful practices by the pharmaceutical industry come to light only because an insider-someone in management or a sales rep-blows the whistle. Fortunately, the Federal False Claim Act provides protection and even incentive for employees to come forward. Pharmaceutical companies settle these types of investigations because, even if they plead guilty to criminal charges, which J&J and Glaxo did, they don't lose the ability to sell drugs to the government as they would if found guilty after a trial.