The government has regulated the advertising of drugs since the 1906 Wiley Act.  Written before the creation of mediums such as radio and television, the Wiley Act attempted to regulate the labeling of drugs and rid the country of falsely labeled and dangerous medications.  The act, however, did little to protect the public from false advertising, because the agency in charge of regulating drugs at the time, the Federal Trade Commission (FTC), only had the authority to regulate false advertising if it could prove that such advertisements injured another company, rather than consumers.[1]

In 1938 the Congress replaced the outdated Wiley Act with the Federal Food, Drug and Cosmetic Act, which provided for the creation of the FDA.  One of the primary reasons for the act was the rapid increase in technology, and subsequently advertising, at the time.  Radio had become an extremely popular medium, and Americans were constantly exposed to marketing of food, drugs, and cosmetics.  The act gave the FDA jurisdiction over the labeling of all drugs.  The FTC, however, was left in charge of regulating the advertising of all such products.[2]

In 1951, the Congress enacted much needed legislation creating a clear division between prescription drugs and over-the-counter (OTC) medication.  The Durham-Humphrey Amendments to the Food, Drug and Cosmetic Act required drugs that are not safe for use except under the supervision of a physician to be dispensed only by a prescription.  Prior to the law the dissemination of such medication was left to the discretion of pharmacists.  The law provided for a clear line between prescription and OTC drugs.[3]

Finally in 1962, the Kefauver-Harris Drug Amendments gave the FDA regulatory power over the advertising of prescription drugs.  The legislation, however, did not discuss the specifics of DTCA.  Rather, it focused on the predominant advertising technique of the time—physician advertising.  Prescription drug advertisements in the United States have historically been aimed at physicians.   Over the past thirty years, however, consumer awareness and the desire for information have risen substantially, and the drug manufactures have responded by marketing their products directly to consumers.  In 1981 a British drug company named Boots Pharmaceuticals placed an advertisement for its drug  Rufen in magazines and became the first documented case of DTCA in America.  Merck followed with advertisements for its pneumonia drug Pneumovax.  After the actions of these two campaigns the FDA was bombarded with submissions of potential DTC ads.[4]

The effect of DTCA of prescription drugs was unknown, and understudied at the time.  Fearing unwanted consequences from this new form of advertising, the FDA issued a formal request to the drug companies for a voluntary moratorium on DTCA.  The purpose of the moratorium was to allow the FDA more time to research the effects that DTCA could potentially have on the public.[5]

The studies done by the FDA were not enough to produce a conclusion on the effects of DTCA.  As a result in 1985 the FDA decided to allow DTCA but maintained pre-existing regulations designed for physicians.[6] Next