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U.S. Department of Health and Human Services

Drugs

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Product Claim Ad (Correct)

Be Smart About Prescription Drug Advertising: A Guide for Consumers

A product claim ad names a drug, says what condition it treats, and talks about both its benefits and its risks. An ad must present the benefits and risks of a prescription drug in a balanced fashion. Balance depends on both the information in the ad itself and how the information is presented. In this ad, the benefits and risks are presented to give a balanced impression of the drug.

Choose a yellow number in the ad for detailed information.

View an Incorrect Product Claim Ad

 

Correct Ad for Arbitraer

 
Number 1Product 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 Ad Slice 1
 
Number 2Product 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 Ad Slice 2
 
Number 3Product 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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Product Claim Ad Slice 3
 
Number 4This 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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Product Claim Ad Slice 4
 
Number 5The 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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Product Claim Ad Slice 5
 
Number 6

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 MedWatch, or call 1-800-FDA-1088."


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Product Claim Ad Slice 6
 
Number 7Print 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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Product Claim Ad Slice 7
 
Number 8The 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 Ad Slice 8
 
Number 9Product claim ads may provide sources of further information, such as a website and toll-free telephone number.

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Product Claim Ad Slice 9


Note: This website does not purport to set forth all the ways in which an ad may violate the law, but rather to explain to the public some of the basic concepts related to drug advertising. 

This site was developed as a collaborative effort between FDA and EthicAd to educate consumers about DTC prescription drug advertisements.