Not every country regulates its prescription drug advertising to the same details and intensity.
Writers aware of these differences save clients’ time and resources by creating content approved seamlessly by the respective regulatory bodies while creating interest around the drug.
While working for US and Canadian brands, I have learned 3 major differences in regulations for advertising prescription drugs:
📺Direct-to-Consumer Advertising (DTCA) Rules:
🇺🇸 US: The United States allows direct-to-consumer advertising of prescription drugs, subject to regulation by the Food and Drug Administration (FDA). Ads must provide a fair balance of information, including both benefits and risks, and must include a brief summary of the drug’s important safety information.
🇨🇦 Canada: ❌ Canada prohibits DTCA for prescription drugs n most cases. Exceptions include drug names not connected to their therapeutic areas. Brands such as Lipitor, Stelara, Tremfya, and Contrave have done this in Canada.
📊 Risk and Benefits Presentation:
🇺🇸 US: In the US, prescription drug ads are required to present a “fair balance” of information, meaning that both the benefits and risks of the medication must be presented in a balanced and clear manner.
🇨🇦 Canada: Same in Canada. However, how elaborate the fair balance needs to be (there are 3 levels: highest, middle, and lowest), depends on how you mention the benefit and what product type you are advertising.
Here is a cheat sheet:
❓ Is there any efficacy data in the deck?
If not, probably you do not need to include the highest level of fair balance.
❓Is it an indication-only deck?
You will probably need to go with the lowest level of fair balance.
❓Are there indications, dose, and other data but nothing about efficacy results?
You will probably need to go with the middle-level balance.
❓ Is the indication already mentioned verbatim somewhere else in the deck?
Then, you can shorten the indication for the balance page.
📋 Submission and Pre-Approval:
🇺🇸 US: Before airing or publishing prescription drug ads, pharmaceutical companies must submit them to the FDA for review and approval. The ads can be aired while the FDA evaluates the ads for accuracy and compliance with regulations.
🇨🇦 Canada: In Contrast, advertising materials for prescription drugs must be reviewed in Canada before they are disseminated.
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