Off-Label Promotion Versus “Not on the Label”

It continues to become increasingly more difficult for pharmaceutical companies to use field-based representatives to educate physicians about their products. Reasons are multifactorial and include physician time demands, negative media attention to the industry, and restrictive policies by some larger practices. However, one important factor is that some physicians may have seen a substantial decrease in the value that pharmaceutical sales representatives can provide because of their companies’ restrictive policies regarding information they are allowed to share.

It is not surprising that industry policies on the provision of information are so restrictive, given the billions of dollars spent by large pharmaceutical companies to settle claims for off-label promotions. This has led to representatives who can only speak about and provide the information (detail aids, article reprints) that is contained in the package insert.

The Problem with PIs

However, while off-label promotion is certainly illegal, there is a big difference between an off-label indication and one not on the label. Although a plethora of important and meaningful data about on-label uses of many products is available, most companies will not allow their representatives to discuss or share it simply because that study is not in the PI. Sometimes representatives will find themselves in a difficult position when a new study about an on-label use of their product receives national press, but their company policy forbids them to discuss it without going through lawyers, compliance officers, and official training.

Just recently, the FDA announced that they would not appeal a federal court ruling that stated Amarin had a free speech right to inform physicians about off-label studies supporting the use of their product, Vascepa, as long as the studies were truthful. The FDA was careful to state that this settlement was “specific to this particular case and situation, and does not signify a position on the First Amendment and commercial speech.” However, several legal experts have stated that this may be an opening to allow other companies to promote their products for off-label uses.

While I am not advocating product promotion for indications that are clearly off-label, I think it is time that the industry reset its barometer on allowing representatives to bring information to physicians that is “truthful and not misleading”—even if that data or study is not specifically contained in the product’s label. As a primary care physician, I find it incredibly challenging to keep up with all the latest information on the vast array of conditions I treat.

Additionally, most new information relevant to my practice is not in the main journals such as JAMA or the New England Journal of Medicine, but rather in subspecialty journals, which I do not subscribe to. Representatives should be allowed to provide physicians with the latest information that is consistent with a product’s indication—even if that information is not specifically in the PI. If pharmaceutical representatives were truly allowed to bring this kind of value, I believe that more physicians would give up a few moments of their precious time to listen.

  • Matthew Mintz, M.D.

    Matthew Mintz, MD, FACP, is Associate Professor of Medicine and Director, Premier Access and Executive Services at The George Washington University School of Medicine in Washington, DC. Visit his blog at