FDA Polices False or Misleading Direct-to-Consumer Prescription Drug Advertising

On September 18, the FDA updated its Special Feature on consumer drug advertising reflecting the latest information on this topic. The United States is one of the few countries in the world that allows direct-to-consumer advertising of prescription drug products. When it comes to advertising and other types of drug promotion, the FDA oversees prescription drug products under the Federal Food, Drug, and Cosmetic Act, and related regulations. The Federal Trade Commission has jurisdiction of over-the-counter drug advertising.


The FDA ensures that drug product advertising is truthful, balanced, and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both health professionals and consumers.


Pharmaceutical companies promote their products to consumers and health care professionals through advertisements appearing in magazines and newspapers, on radio and television, or online. For decades, prescription drug makers promoted products exclusively to health care professionals, who were expected to interpret drug information for their patients. In the early 1990s, some drug manufacturers began targeting consumers. Since then, consumer advertising has become a popular promotional tool.


Drug promotion also includes the use of products such as brochures, notepads, pens, and videos that display drug names or product information. They are often distributed at medical conferences or by pharmaceutical sales reps visiting physicians.


There are several different types of drug promotion. A reminder promotion is designed to increase product name recognition; it does not mention the drug’s uses or make any medical claims. Help-seeking promotion talks about a disease or medical condition, not a particular drug, and encourages consumers to see their doctor if they think they have the condition. A full product promotion describes a specific drug, including information about its uses, benefits, and risks.


Drug advertisements and other promotions must be truthful, accurately communicated, and balanced in presenting a drug’s risks and benefits. “We look for the information presented in drug promotions to be accurate and balanced, and consistent with FDA-approved labeling for the drug,” says Thomas Abrams, director, Office of Prescription Drug Promotion. “Companies must be able to back up any claims made in an ad with substantial evidence from clinical trials or other valid sources,” adds Abrams.


Drug promotion is considered false or misleading if it:

  • promotes the drug as being better or more effective than actually demonstrated
  • implies that a drug is safer or has fewer or less severe side effects than demonstrated
  • claims, without substantial evidence, that its product is better than a competitor’s drug
  • gives a false, misleading or unbalanced presentation of risk information about a drug product
  • promotes the product as being able to treat conditions not approved by the FDA


The FDA’s Prescription Drug Advertising website has some examples of acceptable and unacceptable drug advertisements.


A drug company can submit draft ads or other promotional materials to the FDA for feedback before using them. For the most part, pharmaceutical companies are not required to submit promotional materials to the FDA before they are actually used. But materials must be sent to the agency for review once they are put into use to promote the drug.


Not all promotional materials are submitted to the agency as required. The FDA monitors drug promotion in various ways. For example, the agency closely monitors promotional materials available at professional meetings and conferences. In addition, the FDA receives many complaints from competing drug companies, health professionals, and consumers.


If the FDA finds that a drug advertisement or other promotion is false or misleading, it can take enforcement action. The most common FDA action is a warning letter or a notice of violation sent to the company. Other enforcement actions, though rare, include product seizures, criminal actions, injunctions, and consent degrees.


See the FDA report