Improper “off-label promotion” is a form of fraud used by the pharmaceutical industry to increase profits by selling more drugs than necessary. Before a drug becomes available on the market FDA specifies the uses for which it is safe. Off-label promotion encourages using a product for non-FDA-approved purposes. Physicians may lawfully prescribe a drug for an off-label use. However, manufacturers are prohibited from promoting, or marketing a drug for uses other than FDA-approved uses.
Pharmaceutical manufacturers practice a wide range of abusive activities that provide false and misleading information about the safety or efficacy of products for non-approved uses. For example, it was found by the U.S. Department of Health and Human Services’ Office of Inspector General that the drug corporations will use so-called “medical science liaisons” that present themselves falsely as scientific experts in a particular disease to promote off-label uses.
Moreover, manufacturers will pay physicians to “write” advocacy articles about off-label uses of products that are, in fact, written by the manufacturer. This practice is particularly insidious because the publication of such articles, in medical journals, for example, may be sufficient to qualify the off-label use for reimbursement by taxpayers.
Financial harm to Medicare and Medi-Cal is only one problem caused by off-label promotion.
Off-label promotion leads physicians to prescribe a product for a non-FDA-approved use based on false, misleading, and erroneous information, thus, patients suffer. Additionally, Americans rely on the FDA approval process to evaluate the safety and efficacy of pharmaceutical products.
Off-label promotion strips away this trust.