Sunday, July 23, 2006

The problem with promoting gamma hydroxybutyrate (GHB)

The case of Dr. Gleason concerning the off-label promotion of Jazz Pharmaceutical's Xyrem has attracted some attention.

Doctors are free to prescribe drugs for uses which have not been approved by the FDA (off label uses). Drug companies are NOT free to advertise off label uses. Thus, there is some incentive for drug companies to "encourage" doctors to do what the drug companies can't do. A variant of this problem came up in the Hatch-Waxman context with the drug Neurontin, discussed by me in Intellectual Property Today.

Dr. Gleason got over $100,000 last year from Jazz. That alone probably is not the problem in the aggressive stance taken against Dr. Gleason. The active ingredient in Xyrem is gamma hydroxybutyrate, or GHB, the "date rape" drug. That reality sets this case a bit apart.


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