DO YOU THINK THAT RECOMMENDING NON APPROVED USES OF A DRUG IS AN APPROPRIATE MARKETING STRATEGY? WHY…
Marketing Gone Wrong: Johnson Johnson and Risperdal
Several years ago, the Food and Drug Administration (FDA) approved Johnson Johnson drug Risperdal to treat psychotic disorders, such as schizophrenia, in adults. However, the National Institute of Mental Health found that schizophrenia affects only about 1.1 percent of adults in the United States. According to a lawsuit by the state of Louisiana, Johnson Johnson therefore decided to seek a wider market for the drug by indirectly promoting it for other purposes.
Under U.S. law, if the FDA has approved a drug for treating at least one disorder, doctors are permitted to prescribe it off label, for any other disorder they think the drug will help—even if the FDA has not approved it for that disorder. (The condition the drug is intended to treat must be stated on the labeling.) However, drug manufacturers are forbidden to promote a drug for any other use than the FDA-approved one.
Recently, the U.S. Department of Justice charged Johnson Johnson with paying hundreds of millions of dollars in kickbacks to Omnicare Inc. to buy and promote Risperdal, among other drugs, for off-label uses. Omnicare, the largest pharmacy for U.S. nursing-home patients, allegedly advocated prescribing Risperdal for elderly patients with Alzheimer disease—even though the FDA never approved Risperdal for treating Alzheimer . Johnson Johnson stated, We believe airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate. We look forward to the opportunity to present our evidence in court.