Allergan would seem to have a compelling free-speech case in its suit against the U.S. federal government. In essence, Botox is approved for certain uses, including smoothing facial wrinkles. But off-label uses include treating migraines and easing spasticity. Allergan claims Food and Drug Administration rules barring it from talking about unapproved potential uses of Botox violate its constitutional free-speech rights. As DJN colleague Tom Gryta writes, the regulator lets drug makers “distribute reprints of medical-journal articles that discuss certain off-label uses of drugs, but generally bars company representatives from proactively discussing the material further.” An Allergan executive tells Tom the company isn’t pursuing the case on any other firm’s behalf. Still, if it prevails “drug companies inclined to push the envelope on off-label marketing may feel emboldened,” Tom writes. My father, who died in June 2008, was treated with Botox for spasticity – his hands had become rigid and clawlike as a result of his Parkinson’s or Multiple Myeloma or both. He couldn’t move his fingers at all. A physician prescribed Botox injections to loosen the muscles, so to speak. The FDA allows doctors to prescribe drugs as they see fit, even for unapproved treatments. In my Dad’s case, the Botox didn’t work particularly well – but that might have been because his illness was so far gone or he didn’t pursue the injections long enough. The issue of non-approved uses of prescription drugs is an enormously important one. The Allergan case is certainly one to watch.
