Author: Dee L. Mahoney
Many subtle off-label behaviors occur in an effort to differentiate a product from its competitors. Sara Bloom, Assistant U.S. Attorney in the U.S. Attorney’s Office in Boston, recognized this in late 2009 when she said:
“There are all sorts of ways of going off-label apart from simply asking for a diagnosis that is clearly off-label.”
In sales, product differentiation is ultimately done by describing and highlighting the differences between your products and those of your competitors. One of the best ways to differentiate a product is to position it as superior to a competitor’s product. It is not surprising that unsubstantiated superiority and comparative claims are the most common violations that DDMAC handles, according to Thomas W. Abrams, Director, DDMAC. A typical example of a superiority claim is “Drug X is the best drug on the market for treating depression.”
The laws states that promotional claims may not state or suggest that a drug’s efficacy or safety is comparable or superior to another drug’s without “substantial evidence” to support the claim. Substantial evidence in the world of pharma is defined as:
- Having two or more adequate, well-controlled studies in which the drugs were compared head-to-head using comparable dosing regimens or a single, head-to-head, large, well-controlled study.
- The studies must demonstrate a statistically significant difference to claim superiority.
- Claims may not use verbiage that implies superiority such as drug of choice or preferred, unless there is substantial evidence to support the claim.
Since product differentiation is “ingrained” in the mindset of most sales representatives, companies must make every effort to educate their sales’ teams on compliant and effective promotion. Companies must also invest in clinical research that will meet the substantial evidence guidelines, so sales representatives will be better able to differentiate their products.