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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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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
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
prescription drug advertising must
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
a product claim ad vs a reminder ad
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
key writing elements
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
fair balance
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
substantial evidence
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
  • 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
  • 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
  • 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/UCM076768.htm

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