Off-Label Marketing
The Legal Part
The Federal Food Drug and Cosmetic Act (“FDCA”), provides a systematic scheme for the approval of new drugs and new drug formulations intended to be marketed for use in interstate commerce. Under the FDCA, a new drug product cannot be marketed unless the FDA approves the product and determines that it is safe and effective for its intended use. When the FDA approves a drug, it approves the drug only for the particular use for which it was tested, but after the drug is approved for a particular use, the FDCA does not regulate how the drug may be prescribed. Thus, a drug that has been tested and approved for one use only can also be prescribed by a physician for another use, known as “off-label.”
Though physicians may prescribe drugs for off-label usage known as off-label marketing, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. A manufacturer illegally “misbrands” a drug if the drug’s labeling includes information about its unapproved uses. A drug is deemed misbranded unless its labeling bears adequate directions for use. The courts have agreed with the FDA that the FDCA requires information not only on how a product is to be used (e.g. dosage and administration), but also on all the intended uses of the product. Oral statements and materials presented at industry-support scientific and educational activities may provide evidence of a product’s intended use. If these statements or materials promote a use that is inconsistent with the product’s approved labeling, the product is misbranded under the FDCA for failure to bear labeling with adequate directions for all intended uses.
The Typical Story
One typical off-label story goes like this … In anticipation of achieving FDA approval, or shortly thereafter, the marketing arm of a manufacturer forms and implements a scheme to increase the sales of drug X while avoiding the substantial expense and delay of research and filing an original or supplemental New Drug Application (NDA) with the FDA for approval of expanded, or additional uses of X.
This scheme is carried out by employing, among other things:
a. the illegal direct solicitation of physicians for off-label uses;
b. the making of false statements to physicians and concerning the efficacy of X for off-label uses.
c. illegal kickbacks to physicians in order to induce them to prescribe large amounts of X for “off-label” purposes.
Indeed, sales representatives are instructed and trained how to make claims concerning the safety and efficacy of X for one or more off-label uses. Physicians can only learn of these off-label uses through the manufacturer’s marketing techniques, as the off-label uses are not published in the Drug Compendia as acceptable uses.