222 - What are the restrictions regarding reporting on efficacy in a clinical trial in our news releases? We will be issuing a news release when we receive NOC. We want to say what improvement in patient health was observed in the trial. The trial compared our drug to placebo. How can we explain what happened?
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The Health Canada policy document "The Distinction Between Advertising and Other Activities" outlines the requirements for press releases not to fall in the realm of advertising regulations. I'd like to emphasize four provisions which appear to be particularly relevant to your question.
The first three provisions centre on the principle of sticking to reporting the facts which are indeed "news":
- There should be no statement made regarding the expected degree of safety or efficacy. In other words, limit the discussion to the fact that the study is now complete and the results which were demonstrated versus placebo in that particular study
- Aside from reporting the study results, the announcement should be limited to the name of the drug and its authorized/proposed therapeutic use. In other words there should be no speculation of what the drug's approval or the study's results could mean (e.g. this is a game changer), and no elaboration about previous studies on the sponsor's or competitor's drugs.
- Nothing should imply that the product is a breakthrough.
Additionally, note that a press release should contain no comparisons against other treatments (this should not be an issue in your case as you've noted that this is a placebo controlled study)
Refer to the aforementioned policy for additional requirements relating to the intended audience, appropriate disclosure when the release relates to an unapproved product or unapproved indication, extent of influence on pick-up/visibility, and considerations for products on the Special Access Programme.
Why is it so important that press releases be constructed so as NOT to fall in the realm of advertising regulations?
For starters, they can be accessed by members of the general public while the content exceeds that which is permissible in the consumer advertising realm. Additionally, they tend to relate to unapproved products/uses (advertising of which contravenes section 9.1 of the Food and Drugs Act). Finally, as they focus on what is "new", they're unlikely to meet advertising requirements for disclosure of risk information.
