![Graphic of the number 1 in a circle](images/no1.jpg) |
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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![Graphic referring to critique item 1. Arbitraer (misvastatium) 100mg tablets](images/product_claim_ad_correct_slice1.jpg) |
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![Graphic of the number 2 in a circle](images/no2.jpg) |
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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![Graphic referring to critique item 2. Help Relieve Seasonal Allergy Symptoms](images/product_claim_ad_correct_slice2.jpg) |
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![Graphic of the number 3 in a circle](images/no3.jpg) |
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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![Graphic referring to critique item 3. Arbitraer is a prescription medicine that helps control seasonal allergy symptoms, like runny nose, sneezing, and itchy, watery eyes. By taking Arbitraer, once a day you can relieve your allergy ...](images/product_claim_ad_correct_slice3.jpg) |
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![Graphic of the number 4 in a circle](images/no4.jpg) |
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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![Graphic referring to critique item 4. By taking Arbitraer, once a day you can relieve your allergy symptoms for up to 24 hours. You may begin to experience relief of allergy symptoms 2 hours after taking Arbitraer. You may experience headaches, cold symptoms, coughing, or backaches while using Arbitraer.](images/product_claim_ad_correct_slice4.jpg) |
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![Graphic of the number 5 in a circle](images/no5.jpg) |
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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![Graphic referring to critique item 5. Arbitraer is for use in adults 18 and older. Arbitraer is not for use in children. And there is a graphic arrow pointing to the graphic of the man on the beach.](images/product_claim_ad_correct_slice5.jpg) |
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![Graphic of the number 6 in a circle](images/no6.jpg) |
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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![Graphic referring to critique item 6. See reverse for important information about Arbitraer.](images/product_claim_ad_correct_slice6.jpg) |
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![Graphic of the number 7 in a circle](images/no7.jpg) |
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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![Graphic referring to critique item 7. Ask your doctor if Arbitraer is right for you. This advertisement is entirely fictional — no connection between "Arbitraer (misvastatium)" and any real company or product is intended, expressed, or implied.](images/product_claim_ad_correct_slice7.jpg) |
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![Graphic of the number 8 in a circle](images/no8.jpg) |
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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![Graphic referring to critique item 8. Ace logo Pharmaceuticals 800-555-5555 www.arbitraer.com](images/product_claim_ad_correct_slice8.jpg) |
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![Graphic of the number 9 in a circle](images/no9.jpg) |
Product claim ads may provide sources of further information, such as a website and toll-free telephone number.
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![Graphic referring to critique item 8. Ace logo Pharmaceuticals 800-555-5555 www.arbitraer.com](images/product_claim_ad_correct_slice9.jpg) |