Changes in direct-to-consumer pharmaceutical advertising following shifts from prescription-only to over-the-counter status

摘要

Direct-to-consumer advertising (DTCA) can influence the use of prescription drugs.1-2 The US Food and Drug Administration (FDA) regulates prescription drug advertising, including requirements to provide consumers with a "fair balance" of risks and benefits. When prescription drugs switch to over-the-counter (OTC) status, regulatory oversight of their advertising shifts to the Federal Trade Commission (FTC). Unlike the FDA, the FTC holds drug advertisements to the same standards as any consumer product: it applies a "reasonable consumer" standard of truthfulness and nondeception that does not require any balancing of potential benefits and harms. Such a shift may be associated with changes in content.