The Beginners Guide To Drug Ads Directed to Consumers in U.S.

All drug marketing regulation is not done by the same governmental agency.  The marketing of drugs, in the U.S., is overseen by different departments.  The U.S. Food and Drug Administration (FDA) oversees ads for prescription drugs, the U.S. Federal Trade Commission (FTC) oversees ads for over-the-counter (non-prescription) drugs.  The FDA regulates OTC (over-the-counter) drug labeling, where the FTC regulates OTC drug advertising.


The following information is from the Food and Drug Administration.

 FDA Basics of Drug Ads

Type of Ad	Requirement
Product claim ad: Names a drug and the indication(s); makes claims regarding safety and efficacy	Product claims are made, so “fair balance” does apply and risks are required to be included in a “brief summary.” or (for broadcast ads only) Risks must be included in “major statement,” and “adequate provision” for access to a “brief summary” is required.
Reminder ad: Names a drug, dosage form, and possibly cost, but not its uses	No product claims are made, so “fair balance” doesn’t apply and mention of risks in “brief summary,” “major statement,” or “adequate provision” is not required. However, the FDA does not allow this type of ad for drugs with serious risks (i.e., a boxed warning).
Help-seeking ad: Describes a disease or condition but doesn’t mention a specific drug that treats it	No product is mentioned, nor are any claims made, so “fair balance” doesn’t apply; inclusion of risks in “brief summary,” “major statement,” or “adequate provision” is not required.

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