J&J recently settled with 36 states over claims that it marketed the antipsychotic drug Risperdal for unapproved uses (a/k/a Off-Label). J&J agreed to pay $181 million to the states. What is interesting about this settlement is that one provision, for the first time ever, restricts the way J&J markets their antipsychotics.
J&J agreed to not distribute reprints of peer-reviewed scientific articles showing their drug can be used for purposes other than what is on the FDA approved label. Pharmalot recently posted an interview with industry insider Arnie Friede about the implications of J&J’s agreement to restrict off-label marketing.
Mr. Friede thinks that this agreement has far reaching implications. He went on to say,
J&J/Janssen has said they won’t use sales or marketing personnel to disseminate any off-label reprints unless they’ve already submitted an application to FDA covering that particular use and they may well apply the same “rule” in the marketing of other FDA-regulated products.
Using prescription drugs for unapproved uses is a serious problem. Studies reveal that off-label use counts for 1-in-5 prescriptions. Also, studies supporting the use of drugs for unapproved uses are often biased. An article written on pharmawatchdog.com (my firm’s website) provides,
[A]ccording to a study by international researchers, conflict-of-interest statements made by physicians and scientists in their medical journal articles after they had been allegedly paid by pharmaceutical manufacturers as part of off-label marketing programs are often inadequate, highlighting the deficiencies in relying on author candidness and the weaknesses in some journal practices in ensuring proper disclosure, according to the study published in PLoS Medicine.
Big Pharma was finally caught with their hand in the cookie jar. It’s nice to see beleaguered J&J step-up and agree to curb this practice. This is a significant step towards protecting the public’s health.
Read the Friede interview here: J&J Deal With The States ‘Is Huge’: Friede Explains @Pharmalot.com
Read the PharmaWatchdog article here: Physicians Not Forthcoming With Big Pharma Relationships In Studies Promoting Off-Label Drug Use