2. FDA GUIDELINES FOR ADVERTISING COPYWRITERS

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

4.  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 WHY SHOULD I CARE?

5.  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 PRESCRIPTION DRUG ADVERTISING MUST

6.  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 3 rd type of drug ad: a help-seeking ad  Describes a disease or condition but does not recommend or suggest specific drugs A PRODUCT CLAIM AD VS A REMINDER AD

7.  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 KEY WRITING ELEMENTS

8.  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 FAIR BALANCE

9.  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 SUBSTANTIAL EVIDENCE

10.  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 CLAIM

11.  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 BENEFIT

12.  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/Prescr iptionDrugAdvertising/ucm168421.htm EXAMPLES

13.  http://www.fda.gov/Drugs/ResourcesForYou/Consumers/Pres criptionDrugAdvertising/UCM076768.htm RESOURCES

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