Earlier this year, the FDA revisited its policies on distributing reprints of medical and scientific journal publications in its revised draft guidance entitled, “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” . If it stands as drafted, the new guidance will basically allow industry to distribute journal articles and clinical practice guidelines (CPGs) regarding off-label use of their products to the medical community.
It’s a fine line between the drug company informing doctors about a new potential benefit in an off-label indication and the illegal promotion of product for increasing sales. In my (KW) opinion, this new guidance sends mixed messages. On the one hand, the FDA states that it “recognizes the value to health care professionals of truthful and non-misleading scientific or medical publications on unapproved new uses.” But as everyone knows, including the FDA, the medical journal articles are often biased because the authors or ghostwriters are paid by the company whose product is being studied. This should be very concerning to the doctors and patients alike.
In recent years, over $13B in fines has been paid by major drug companies to settle lawsuits against them for their fraudulent marketing practices, including off-label promotion of their drugs/devices not approved by the FDA. Based on their current track record, the drug companies will continue to use misleading publications to promote off-label use of their products. As Dr. Catherine DeAngelis, former editor-in-in chief of JAMA, stated about drug makers using reprinted journal articles: “Of course they are doing it promotionally. Why else would they do it”?
Off-label prescribing has always been a big concern of mine as my husband, Woody, was prescribed an antidepressant off-label for an insomnia diagnosis. Five weeks later without any history of depression or any other mental illness he took his own life. I doubt Woody was even aware that the drug given by his doctor wasn’t approved for insomnia. Drugs are often used off-label, with nearly 80 percent of off-label prescriptions lacking “strong scientific evidence,” which means we do not know if their risks outweigh their benefits. Ultimately, its buyer beware.
It’s one thing if you have a rare disease and are desperate to try something that might offer hope. Its another thing if you went into your doctor because you’re having trouble sleeping due to stress of a new job. Again, it’s a fine (yet potentially deadly) line patients are walking. We need to be told if the FDA has approved the product or if its being used off-label based on an article that appeared in some journal. Otherwise, we are just guinea pigs.