Drugmaker Allergan recently agreed to pay $600 million to resolve federal charges that the company improperly marketed Botox (onabotulinumtoxinA) for off-label use. On Call wondered whether dermatologists think that this increased effort in enforcing off-label marketing rules is a good pursuit for the government. Would derms rather they never be allowed to hear about potentially beneficial off-label uses from drug reps?
Ironically, the Food and Drug Administration (FDA) is currently reviewing Botox's effectiveness in relieving migraine headache pain; that indication has already been approved in Europe.
While physicians are allowed to use any FDA-approved medications for any indication they think will benefit, the federal government has been strenuously enforcing rules against drug manufacturers marketing drugs for off-label uses, even when the use has become generally accepted.
Several dermatologists who spoke to On Call say they have mixed feelings about the issue. Although they agree the government has the right to pursue companies for off-label marketing and they understand the need for some type of control on the companies, they say they also would like manufacturers to have more leeway when it comes to providing information on off-label uses of their drugs.
Most of the doctors interviewed suggested that a major part of this issue comes down to money - at least one way or another.
Daniel Kaplan, M.D., of Minneapolis, says, "Allergan just got caught; that's what happened. Everybody does it, and they look at it as just naturally drumming up business."
Primarily a researcher in immunology, the assistant professor at the University of Minnesota says, "If dermatology didn't use medications off-label, we would have no medications. So many of the diseases we treat occur infrequently that we have been somewhat ignored by a lot of big drug companies. As a result, dermatologists have to use medications off-label."
Dr. Kaplan suggests there are better ways, however, for doctors to get information about beneficial off-label uses than through company promotion.
"There's enough obfuscation that occurs in marketing and advertising; unless you have a basic set of rules, it can be taken too far. There's no rule against publishing findings from off-label use. Then, if it's a big enough advantage for the companies, they'll do the studies that will allow them to market the product," he says.