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Hi @supraja, 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. 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. No, they may not contain competitor brand/generic/manufacturer names. Please see SEM Keywords PAAB Forum post and PF Q 456. 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.

Hi @maryssa, Pre-NOC is considered when a drug product has not yet been approved for use in Canada. For unbranded disease information material without mention of any drug treatment/pharmacotherapy or pre-NOC editorial material, they may be submitted for full review or opinion at any time. Please see our Pre-NOC Corporate/Editorial communications for additional information and cautions regarding pre-NOC communications. While the unbranded disease information without mention of any drug treatment may meet criteria for exemption, we suggest submitting for an opinion as the PAAB reviews help to ensure the company and materials are not inadvertently in violation of C.08.002 of the Food and Drug Regulations.

@jennifer-carroll Short and sweet, thanks Jennifer!

Hi @charlton, Pragmatic trials are interventional in nature, as they involve random assignment to the treatment groups. Given this fact, it would be inaccurate to refer to them as ‘observational’ studies. However, they differ in important ways from randomized control trials (RCTs). RCTs are designed in a manner that prioritizes a highly controlled environment. While this comes at the cost of an artificial environment that can differ from the actual surrounding environment, it reduces the potential for biases that could impair the validity of causal inferences. While their results should be generalized cautiously to the real-world, they have high internal validity when designed, executed, analyzed, and reported properly. Pragmatic trials are designed to prioritize reflecting the surrounding environment. This is why they are said to provide insights about “effectiveness”, which is the benefit that the treatment produces in routine clinical practice. For example, pragmatic trials tend to include patients with comorbidities, the methodology aims to reflect the lower adherence levels that occur in clinical practice, blinding is rarely utilized (as it does not reflect real-life practice), and investigators have more clinical freedom to make therapeutic decisions (i.e., less protocol standardization than in RCTs). Due to the above, PAAB considers pragmatic trials to fall within the realm of RWEs. Please see our RWE guidance document on parameters for acceptability and presentation format.

Hi @hrj2021, Yes, efficacy and safety data that meets PAAB requirements may appear together in APS.

@jennifer-carroll Thanks so much. This is most helpful.

Hi @username, Without knowing the specifics of the file you are speaking to; we can convey that experience claims tend to have nuances to them that are set by the context around them which the reviewer can help you better understand in the context of the review. In the context of this being the only claim on the page, the copy “X years in Canada across indications” is inherently misleading as not all indications have been authorized for X years. It creates an erroneous impression for time on the market for some indications. For this type of experience claim, the underlying PAAB code section 2.1 and principle has not changed. The request for clarity and accuracy regarding years of experience have been applied for many years with the initial appearance of such claims in advertising. We do our best to inform clients about changes and will continue to look for opportunities to do so. When an issue does not affect a large number of pieces, we do tend to error on the side of conveying the change in files when the issue is noted. This helps to ensure that we are not overwhelming clients with every review ruling. We can look for opportunities to increase that scope and frequency. In the second example, there has been no change to the requirement to disclose to HCPs when you are directing them to content that was designed for consumers or patients. The perception that this is a change might be rooted in the fact that PAAB noted that clients were adding consumer messaging to HCP pre-gate landing pages. As such, we would ask for the clear disclosure that they were being directed to content intended for a consumer audience. The nature of the content on the pre-gate page changed, which is what prompted the request. The application of the Code did not change. The reviewer can help explain the nuances of your example in the file. Please reach out through efiles.

Hi @supraja When a Risk Management Measure/Tool (RMM/T) is intended to be distributed with any other PAAB reviewed pieces, the entire package is considered in context and should be submitted as a separate PAAB review/opinion. We are unable to comment on the compliance of the proposed APS without assessing the content of the APS and suggest submitting for review or an opinion. During the review, we would be able to provide advice on the acceptability of the APS content and its linkages. Any folder intended to be combined with an RMM/T is also subject to PAAB review. Please see our guidance document on RMM/RMTs for context of use and other information.