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Product claim ads must identify the drug's brand and generic names. The ad correctly mentions the fictional drug's brand name, Arbitraer, and its generic name, misvastatium.
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Product claim ads must accurately state an FDA-approved use for the drug. In addition, the ad may not make a claim that is not supported by substantial evidence or substantial clinical experience. This ad appropriately states that Arbitraer is approved to treat seasonal allergy symptoms.
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Product claim ads should say that the drug is given by prescription only. This ad appropriately states that Arbitraer is a prescription drug.
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This ad provides the required "fair balance" of information about the risks and benefits of Arbitraer. The ad as a whole does not put more emphasis on the drug's benefits than its risks.
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The man on the beach who is pictured in the ad is in the approved age range for users of the drug. The ad also reinforces this point by stating that Arbitraer is for adults 18 and older and is not for use in children.
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As required by the Food and Drug Amendments Act of 2007, print ads must include the statement "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088."
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Print ads must include a "brief summary" of all the risks listed in the drug's FDA-approved prescribing information. The "brief summary" contains one or more pages of important information about a drug's risks. The "brief summary" usually follows the part of the ad that displays colorful images and graphics.
View the Brief Summary (23Kb)
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The ad directs the reader to seek a doctor's advice about taking Arbitraer. The drug company has included this statement as a way to ensure that a consumer will not think he or she is qualified to make the prescribing decision.
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Product claim ads may provide sources of further information, such as a website and toll-free telephone number.
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