Dr. Richard Hoffmann, Ask the Pharmacist, 03/19/13

Q: How does the Food and Drug Administration (FDA) protect the public from false advertising?

A: The United States is one of the few countries in the world that allows direct-to-consumer advertising of prescription drug products. Chances are you have seen these commercials on TV. They often feature a celebrity spokesperson discussing a particular drug or an actor playing the role of a satisfied patient.

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 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 advertisements and other promotions must be truthful, accurately communicated, and balanced in presenting a drug’s risks and benefits. 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.

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.

Richard P. Hoffmann, Pharm.D., has been a pharmacist for more than 40 years. Send questions to him at 2960 E. Coventry Court, Hernando, FL 34442.