FDA Guidelines for Advertising Copywriters

FDA Guidelines for Advertising Copywriters

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

Pharmaceutical companies spend millions of dollars on drug advertising When copy is flagged for lack of regulatory compliance, it causes delays and increases costMultiple rounds of regulatory review by clientsErrors/misleading claims increase regulatory scrutiny and mistrust with agencyClient ultimately unhappy with agency and increased likelihood of relationship problemsIf 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?

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

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 risksThere is a 3rd type of drug ad: a help-seeking ad Describes a disease or condition but does not recommend or suggest specific drugsa product claim ad VSa reminder ad

There are several key elements to know when it comes to writing your copy:

Fair Balance/Important Safety Information (ISI)Substantial InformationClaimBenefitBrief SummaryRisks/Side Effects

Key Writing Elements

In product claim advertising, fair balance refers to the presentation of accurate and fair assessment of both the benefits and the risks of a drugThe content/presentation of a drug's risks must be similar to the content/presentation of its benefitsThis 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 adsThe 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 presentedThe risk information is often called the important safety information or ISI

Fair Balance

Substantial evidence is the data that support claimsBefore 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 drugA drug must be supported by at least twostudies to support claimsSubstantial EVIDENCE

A claim says something about the advertised drug or what it does. Claims usually relate to benefitsClaims 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 childrenAds 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

A benefit is a positive result(s) provided by a drugE.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 experienceBenefit

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.htmEXAMPLES

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/UCM076768.htmResources

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