Once the FDA approves a drug for one condition or disease, doctors are free to prescribe it for another, a situation defined as prescribing “off-label.” This is not always a good idea, but there is latitude in a legal sense to use a drug for a condition not strictly approved by regulation, but considered by the physician to be useful (if not necessarily safe or appropriate). As for marketing, however, pharmaceutical companies are not allowed to promote such off-label uses. Usually, when this occurs (or is discovered), the company responsible is subject to heavy fines by the FDA.
The New York Times, however, just reported that the former head of a drug company was convicted of wire fraud for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug. The former chief executive of InterMune was, however, acquitted of the related charge of “misbranding,” that is, off-label marketing itself. It seems like splitting legal hairs, yet the gentleman in question faces a jail term if his appeal fails.
This should strike fear into corporate executives who can hide behind a corporate shield when they promote drugs with false or misleading information.
The whole concept of off-label use by doctors and promotion of drugs for unapproved uses of new-and old drugs-deserves to be reassessed, not only by the Government, but by the research community. I can offer many examples in a coming blog.
The next time your doctor prescribes a new drug for, let us say, fibromyalgia or depression,or anything else, it might be wise to ask him or her if this is an off-label use. Sometimes, in the case of life-threatening illness when options have been exhausted, off-label use of a drug might make sense, but in other situations, it might conceivably lead to patient-and doctor’s-remorse.