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FDA Guidelines for Advertising Copywriters

FDA Guidelines for Advertising Copywriters . MODULE OBJECTIVE. At the end of this module, you will be able to recall FDA regulations related to pharmaceutical advertising with 100% accuracy. Why should I care?. Pharmaceutical companies spend millions of dollars on drug advertising

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FDA Guidelines for Advertising Copywriters

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  1. FDA Guidelines for Advertising Copywriters

  2. MODULE OBJECTIVE At the end of this module, you will be able to recall FDA regulations related to pharmaceutical advertising with 100% accuracy

  3. Why should I care? • Pharmaceutical companies spend millions of dollars on drug advertising • When copy is flagged for lack of regulatory compliance, it causes delays and increases cost • Multiple rounds of regulatory review by clients • Errors/misleading claims increase regulatory scrutiny and mistrust with agency • Client ultimately unhappy with agency and increased likelihood of relationship problems • If an error/misleading claim slips through review, the FDA can mandate corrective advertising (at clients’ expense) and seek punitive actions against client, agency and responsible personnel

  4. Prescription Drug advertising must • Be accurate • Balance the risk and benefit information • Be consistent with the prescribing information (PI) approved by FDA • Only include information that is supported by substantial evidence or substantial clinical experience

  5. a product claim ad VSa reminder ad • A product claim ad names a drug, the disease/condition it treats, and presents both its benefits and risks. • A reminder ad gives the drug's name but not the drug's use nor its benefits and risks • There is a 3rd type of drug ad: a help-seeking ad • Describes a disease or condition but does not recommend or suggest specific drugs

  6. Key Writing Elements • There are several key elements to know when it comes to writing your copy: • Fair Balance/Important Safety Information (ISI) • Substantial Information • Claim • Benefit • Brief Summary • Risks/Side Effects

  7. Fair Balance • In product claim advertising, fair balance refers to the presentation of “accurate and fair assessment of both the benefits and the risks of a drug” • The content/presentation of a drug's risks must be similar to the content/presentation of its benefits • This does not mean that equal space must be given to risks and benefits in print ads, or equal time to risks and benefits in broadcast ads • The amount of time or space needed to present risk information will depend on the drug's risks and the way that both the benefits and risks are presented • The risk information is often called the important safety information or ISI

  8. Substantial EVIDENCE • Substantial evidence is the data that support claims • Before FDA approval, drug companies must complete studies to show the drug does what they say it does • They also required to support advertising claims about the drug • A drug must be supported by at least two studies to support claims

  9. Claim • A claim says something about the advertised drug or what it does. • Claims usually relate to benefits • Claims can be made directly by stating, for example, "Brand X treats heartburn” • Claims also can be made indirectly by the use of pictures or other graphics. • E.g.: an Ad featuring a playground full of children may suggest a claim that the advertised drug treats children • Ads for prescription drugs can only make claims that are consistent with the drug's "prescribing information” • The truthfulness of claims must be supported by "substantial evidence" or substantial clinical experience

  10. Benefit • A benefit is a positive result(s) provided by a drug • E.g., the benefit of a cholesterol drug is that it lowers the levels of bad cholesterol (low-density lipoprotein, or LDL, cholesterol) • Benefits can only be advertised if they are related to the FDA-approved use • Advertised benefits must be supported by "substantial evidence” or substantial clinical experience

  11. EXAMPLES • Here is a link to the FDA website for correct and incorrect advertisements for product claim ads, reminder ads, and help-seeking ads http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm168421.htm

  12. Resources • http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/UCM076768.htm

  13. Conclusion You should now know key writing elements in regards to FDA regulations that you can apply when developing copy

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