The Food and Drug Administration is the agency charged with regulating food, drugs, medical devices and cosmetics. The agency has issued a guidance document for manufacturers providing information on comply with FDA marketing guidelines.
Direct-to-Consumer Advertisement
Consumers often receive information about prescription drugs and medical devices from the manufacturer's direct-to-consumer advertisements. For this reason, consumers should be made aware of risk factors associated with a prescription drug or medical device.
Entire Advertisement Approach
The FDA evaluates marketing and promotional materials using a whole material approach. The agency reviews not only individual statements but considers whether the entire content presents consumers with a fair and balanced idea of the risks and benefits associated with a product.
Reasonable Consumer Approach
When evaluating marketing and promotional materials, the FDA considers whether a reasonable consumer would be misled by the content. If materials contain statements that could be interpreted in other ways, the agency holds the manufacturer responsible for the misleading or erroneous interpretation.
Presentation of Risk Information
When evaluating marketing and promotional materials, the FDA also considers how risk information is presented to consumers. For example, the FDA encourages manufacturers to use clear and consistent language in marketing and promotional materials that will be easily understood by consumers.
