“Off-label” marketing by drug companies is conducted to expand market share and sales without conducting the requisite scientific testing to to gain FDA-approval for an indication that others in the class enjoy. “Off-label” drug utilization, when driven by deceptive marketing, is proven to be a risk-laden and potentially harmful practice. A common tactic to drive utilization used by a minority of pharmaceutical manufacturers is to advance the “class effect” assertion to physicians, which by definition attempts to blur the distinction in FDA-approved indications amongst drugs which are in the same or similar family or “therapeutic classes.”
“Therapeutic classes”, it must be emphasized, are grouping of drugs for convenience so as to provide taxonomy, or titling, which makes groups of chemical properties and physiologic effects easier to identify. These “classes”, however, are artificial groupings, which may contain drugs with widely disparate medical uses, albeit being structurally, or chemically similar as molecular entities. Not all drugs within each “class” can be assumed to have identical medical effects when given to patients. The following examples are illustrative:
- The broad-spectrum antibiotic ampicillin was first introduced, then followed by two important refinements, amoxicillin and amoxicillin clavulanate. Although all three of these molecules are in a single “therapeutic class”, their antibiotic potencies versus many bacteria are very different. Accordingly, they warrant selection with maximum specificity when treating applicable bacterial infections.
- The cancer drug Daunorubicin belongs to a “therapeutic class” entitled anthracycline anti-cancer drugs. Other drugs in the anthracycline therapeutic class include Doxorubicin and Epirubicin. The approved indications of the “anthracycline” drug class oncology drugs are very different, however.
- In the cardiovascular field, angiotensin-convertingenzyme (ACE) inhibitor and angiotensin type 1 receptor blockers [ARBs] have all been approved by the U.S. Food and Drug Administration for the indication “hypertension.” The indication for hypertension does not necessarily mean that the drug has been shown to reduce multiple indications such as the cardiovascular complications of hypertension, or that it provides protection against heart failure or vascular disease.
These are just a few examples of therapeutic classes where “class effect” marketing could be utilized to the detriment of patients. Such marketing, when misleading, could readily serve as a basis for a False Claims Act lawsuit by whistleblowers.