History of Direct to Consumer Advertising of Prescription Drug Products in US

History of Direct to Consumer Advertising of Prescription Drugs in the U.S.

Imagine this: you are at home watching television one evening after work. As you casually flip through the channels searching for something interesting to watch, you notice a multitude of advertisements for prescription drug products. This form of advertisement is known as direct-to-consumer advertising, and is now well-known to practically all American households. One needs only to watch virtually any commercial television program or to browse through any consumer-directed magazine to view advertisements for a variety of prescription drugs. In regard to broadcast media, this is a relatively new phenomenon because, for many years, pharmaceutical manufacturers had to follow certain requirements. These requirements consisted of the inclusion of a substantial amount of material about the drug product's side effects, contraindications, and effectiveness.

Recent changes in 1999 under the guidance of the Food and Drug Administration (FDA) altered the decision making balance between patients and physicians. Historically, prescription drug advertising in the United States was directed primarily at physicians, who were once the sole decision-makers when choosing prescription drugs. As patients became more involved in their treatment, drug companies expanded their promotional efforts to include consumers. The first U.S. prescription drug print advertisement directed to the consumer was issued in 1981 by Boots Pharmaceuticals, for the ibuprofen product. Other drug companies then voluntarily proposed direct to consumer advertisements to FDA. During that time, the FDA and the industry conducted several studies on the effects of these types of advertisements.

In September of 1985, FDA released requirements stating that direct to consumer advertisements must meet the same legal requirements as those directed at physicians. The FDA maintained that pre-existing regulations governing prescription drug advertising would sufficiently safeguard consumers. As a result, pharmaceutical companies began to expand their promotional activities. Historically, the first comprehensive federal legislation regulating food and drugs was the Pure Food and Drugs Act of 1906. This Act was directed toward product labels only and contained no provisions regarding advertising. At the time of its enactment, the labels under which drugs were sold were the primary medium for drug promotions. The Pure Food and Drugs Act defined a product as misbranded only if its label contained false statements about its ingredients' curative or therapeutic effects.

Since the Act did not require manufacturers to prove the safety or efficacy of their products prior to marketing, many false claims for a drug that were not on the allowed unsafe drug products to remain on the market. At that time, the Federal Trade Commission (FTC) did not have the authority to regulate deceptive advertisements unless it could prove that such advertisements injured another company. In 1938, the Federal Food, Drug, and Cosmetic Act repealed and replaced the Pure Food and Drugs Act. This was a result of the significant increase in the advertising of foods, drugs, and cosmetics. Accordingly, consumer protection from fraudulent marketing techniques was one of the important goals behind the new food and drug law. Congress was concerned not only with dangerous products on the market, but false marketing claims as well.