FDA Approves Risperdal for Children: A Medical Advance or a Marketing Game?

For those who follow the mental health news, a big news release was issued recently:

FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents.

Per the news release:

"The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups.

Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up."

For those of you who don't know how the approval process works, here is a good thumbnail from an article done by Loren R. Mosher, Richard Gosden and Sharon Beder called Drug companies and Schizophrenia: Unbridled Capitalism meets Madness. There is a bias to the article, and it focuses on schizophrenia, but it's still applicable to bipolar disorder, and an informative read:

"The American process will be described but it is roughly similar in all western European countries. For a new drug, two studies must be submitted to the Food and Drug Administration (FDA) indicating the drug is better than placebo and is without serious adverse effects for condition "X". The drug need not be more effective than ones already available for condition "X". Data from "failed studies"-those showing no significant drug placebo differences- are not supplied to the FDA. If approved, the drug can be marketed for condition "X". The companies can later apply, by submitting new studies or new analyses from old studies for the drug's indications to be extended to new conditions or new populations (e.g., youth, the elderly). This opens a new market. The "new indications" technique has proved to be highly successful with the SSRI's: first approved only for depression but now approved for obsessive compulsive disorder ("OCD"), post traumatic stress disorder, and various anxiety disorders.

Of great importance is the fact that once a drug is on the market an individual doctor can legally prescribe it for "off label"(unapproved) indications..."

So what has happened here is the manufacturer, Janssen, has taken the time and huge expense to pursue the approval process with respect to Risperdal and youth. This is understandable, as it potentially opens up a whole new market for them. Or does it? I would imagine many, if not most, medical professionals who would prescribe Risperdal for youth are already doing it off-label. And another thing, Risperdal goes off-patent soon, next year if I'm not mistaken. Janssen has little time to recoup their investment. So what gives?