Saturday, July 22, 2006
Criminal Law I: promoting off-label uses of approved drugs
Now, it's horn-book law that physicians can use approved drugs for off-label uses. And it's equally well-settled, though perhaps a little less well-known, that pharmaceutical companies cannot themselves promote their approved drugs for nonapproved (or "off-label") uses without formal FDA approval; they have to limit their claims for the drug's safety and efficacy to those uses for which they submitted data to the FDA and received that agency's marketing approval. (Max Mehlman has a good essay on this. The FDA's rule is here.)
But it is apparently perfectly okay for a pharmaceutical company to pay a physician to promote the off-label use of the company's approved drug or, as the Times article puts it: "Despite the F.D.A.’s constraints on drug makers, though, the companies are allowed to hire independent doctors to talk to other physicians about their medicines. Companies can also sponsor 'continuing medical education' sessions, ranging from lunches to weeklong conferences, where specialist doctors tell other physicians about the latest developments in their fields — including off-label uses for drugs already on the market. For such speaking engagements, doctors can receive $3,000 or more a day from the companies."
So how did Dr. Gleason get into so much trouble? It's not that clear. Perhaps the FDA decided to rein him in because it viewed his claims concerning Xyrem's safety -- i.e., that it was as safe as table salt and safe for children -- extravagant and dangerous, considering that its active ingredient is GBH (the "date rape drug"). Or perhaps it's because Dr. Gleason did not agree to cooperate with the government's investigation of his former benefactor, Jazz Pharmaceuticals, which has not yet been charged with anything. What is clear is that the FDA's rules don't provide much guidance for this practice and the basis for a criminal prosecution in Dr. Gleason's case is shaky at best. Stay tuned . . . .