The FDA Approach to Defining Misleading Advertising

The amount of time, effort, and money invested to promote prescription drugs in this country is staggering. It is estimated that over 1 billion are spent annually to disseminate information to the physician. This figure is more than three times the total annual budget of all U. S. medical schools, and it constitutes 1 out of every 1000 of the American gross national product. Drug promotion was not regulated with any consistency until the early 1960s. At that time, disclosures before Senator Kefauver's Subcommittee on Antitrust and Monopoly revealed that advertising to the medical professions had resulted in serious abuses which required new, specific controls for the protection of the public. On October 10, 1962, the Drug Amendments to the Federal Food, Drug, and Cosmetic Act gave jurisdiction over prescription drug advertising to the Food and Drug Administration (FDA). In most cases, whether a prescription drug advertisement is false can be objectively determined and is independent of any impact it may have on the consumer. For example, if an ad for a penicillin medication claims that it can cure certain types of breast cancer, this claim can be objectively disproved without any input from the consumer/reader of that ad. The difficulty lies mainly with the advertisement that contains true, letter-perfect information from a regulatory standpoint, yet still creates a misleading impression.