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The Pharmaceutical Advertising Advisory Board (PAAB) has published a draft guidance document on the use of real-world evidence (RWE) in advertising directed to healthcare professionals (HCPs). The draft guidance document is available upon request from PAAB. PAAB is inviting industry stakeholders to provide feedback on the draft guidance document until the consultation period closes on April 3, 2023.

According to the draft guidance document, PAAB recognizes that not all clinical data that is relevant to clinical decisions by HCPs may be supportable by controlled and well-designed clinical trials with demonstrated statistical significance (so-called gold standard data). PAABs aim is to create a framework for use of RWE in advertising to facilitate delivery of the best data currently available to HCPs even in the absence of gold standard data, provided that the RWE data is sufficiently robust to be relevant and valuable to clinical practice.

Under PAABs proposed approach outlined in the draft guidance document, RWE may be used in advertising in addition to gold standard data, provided that the RWE data meets certain base requirements for validity and relevance and is presented in the advertisement in alignment with certain formatting principles, each of which is described below.

The draft guidance document provides the following nine criteria to be used to ascertain whether RWE meets basic requirements for validity and relevance:

The draft guidance document provides the following five principles for presentation of RWE data in advertising:

The draft guidance document provides examples of the application of these principles to visual advertisements, as well as adaptations of these principles for advertisements in video or audio formats.

Ourlife sciences team has significant expertise advising the pharmaceutical industry on advertising compliance and other matters and is available to consult on the draft guidance document.

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PAAB Publishes Draft Guidance Document on Use of Real-World ... - Fasken