Background on Drug Advertising
The Food and Drug Administration (FDA) protects public health by assuring the safety, effectiveness, and security of a wide range of products, including human prescription drugs. We also advance public health by helping people get the accurate, science-based information they need to use medicines appropriately and improve their health.
FDA Authority Over Advertising
We serve the public health and welfare in many ways. One way is overseeing the approval and marketing of prescription drugs. Our authority is based on a number of federal laws, including the Federal Food, Drug, and Cosmetic Act. Among other areas, this law specifically addresses prescription drug advertising. This law requires that advertisements for prescription drugs be accurate and not misleading.
Direct-to-consumer (DTC) advertising is a relatively new area of prescription drug promotion. No federal law has ever banned DTC advertising. Until the mid-1980s, drug companies gave information about prescription drugs only to doctors and pharmacists. When these professionals thought it appropriate, they gave that information to their patients. However, during the 1980s, some drug companies started to give the general public more direct access to this information through DTC ads.
OPDP — Office of Prescription Drug Promotion
Part of the mission of the FDA's Center for Drug Evaluation and Research (CDER) is to ensure that companies that sell prescription drugs also provide information that is truthful, balanced, and accurately described. CDER's Office of Prescription Drug Promotion (OPDP) oversees prescription drug ad activities. OPDP does this work by: (1) looking for and taking action against advertisements that violate the law; (2) educating industry and others about the specifics of the law; and (3) encouraging better communication of promotional information provided both to healthcare professionals and to consumers.
More detailed information on laws, regulations, guidances, and enforcement actions regarding drug marketing, advertising, and communications.
Protecting consumers requires listening to them. We routinely consult the American public when making decisions about drugs. We do this by holding public meetings to get input from experts, patients, and consumers. We also announce many of our proposals in advance. This gives all those who are interested the chance to make suggestions before we make a final decision. All of these meetings improve public input into our planning and priority-setting activities.
Note: This website does not purport to set forth all the ways in which an ad may violate the law, but rather to explain to the public some of the basic concepts related to drug advertising.
This site was developed as a collaborative effort between FDA and EthicAd to educate consumers about DTC prescription drug advertisements.