America's Most Admired Lawbreaker

The Rise of Risperdal

Johnson & Johnson (J&J) developed Risperdal to replace its antipsychotic drug Haldol, which by 1986 was no longer under patent protection. J&J sought to market Risperdal as a “step up” from Haldol. It also hoped to capture the broad market share that Haldol targeted as a treatment for a wide range of conditions, including dementia and Attention Deficit Disorder. However, the US Food & Drug Administration (FDA) did not approve J&J’s broad-uses pitch for Risperdal. Regulators found that J&J hadn’t provided proof that it was in any way superior to Haldol. Moreover, the FDA claimed J&J’s tests didn’t establish Risperdal’s safety or effectiveness in seniors and children or for any use except treating adult schizophrenia.

Circumventing the FDA

To meet its desired profit margins, J&J had to expand the sale of Risperdal beyond its label. To this end, J&J focused its marketing efforts on doctors – who aren’t required to follow FDA guidelines when they prescribe if they believe a given drug is the best course of treatment for a patient. Specifically, J&J wanted Risperdal to...