DTC SEM Campaign for Vaccines

[Supraja]

Hello,

I have a few questions regarding DTC SEM for vaccines:

1. I understand that SEM ads for Schedule D drugs can contain claims. However, what are the other differences in the regulations for SEO/SEM when it comes to vaccines?
2. Can keywords for a vaccine's SEM campaign include indication, patient population etc?
3. Can keywords for a vaccine's SEM campaign include competitor brand/generic/manufacturer names?
4. If the DTC SEM campaign is only reviewed by ASC (and not PAAB), then do PAAB's guidelines still apply?

I have scanned forum posts regarding SEM and read the guidance on online activities but couldn't find an answer when it comes to vaccines. Appreciate your guidance!

[Jennifer Carroll]

Hi @supraja,

1. DTC SEO and SEM are subject to the Food and Drugs regulations, the Therapeutic comparative advertising: directive and guidance document and the Interim guidance – Fair balance in direct to consumer advertising of vaccines.
2. Yes, they may include indication and patient population provided they do not contravene the federal regulations, particularly section 9(1) of the Food and Drugs Act.
3. No, they may not contain competitor brand/generic/manufacturer names. Please see SEM Keywords PAAB Forum post and PF Q 456.
4. The PAAB code applies to HCP advertising and patient information. DTC advertising is subject to the Health Canada regulations regardless of the preclearance agency who performs the review. When DTC advertising is used to drive HCPs or patients to a website, it is considered to be a dual audience and may be subject to the PAAB Code and Health Canada DTC regulations. If you are unclear if your tool falls in the dual category space, PAAB can provide an opinion.