FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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363 - Can you please remind me of the rules related to printing and distributing your product monograph? I believe you can reprint it exactly as is and to do so would be PAAB exempt. However, if you add a cover with your brand identity, your logo and indication statement(s), yet no claims, is that now classified as a "commercial" PM and thus requires PAAB review? Or is it only if you make a claim on a branded front cover? TIA
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360 - A client wishes to produce some material that will be strictly used by their medical team (i.e. MSLs, Med Affairs, Medical Education Specialists). It will contain product efficacy outcomes that will be balanced with safety and AEs, and thus will be strictly used in a non-promotional manner. The piece itself will meet the requirements of Health Canada as NOT being advertising, but they wish to have a PAAB exemption letter. QUESTION: Looking at section 6.6(iv) of the code, one of the exemption scenarios involves: Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in in any way. Could you clarify what 'therapeutic message' entails? Would efficacy charts be considered a therapeutic message?
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343 - We are planning market research with healthcare professionals to identify new marketing insights and opportunities. The research will be in the form of informal interviews/discussions with HCPs. Does the PAAB need to be involved with the research planning? This would be organized and conducted by an agency and the sponsoring client would only receive anonymous insights and findings. Does the answer depend on any of the following? If interview questions are provided to the HCP in advance vs. an impromptu discussion? If the interview/discussion covers specific products vs. only diseases.
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328 - Our client would like to have a website about the features of its medical device (a self-injection device). The website would not mention the name of the drug that goes in the device but it would mention the therapeutic area. The intended audience is patients who would be directed to the website by their HCPs. Am I correct that this website requires PAAB pre-clearance? What if the website had content only about the features of the medical device and did not mention the drug product in any way and did not mention the therapeutic area, would it then be exempt from review since the PAAB doesn't review medical devices? Or would it require pre-clearance because it is sponsored content that patients are being directed to? Thanks in advance for your response.
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325 - Good morning, regarding a patient care program related to a specific drug that pharmacists can participate in to support their patients, does a document communicating: what the program is about, including that it's for patients diagnosed with illness A and prescribed Drug A (no claims or any other info about the drug) how the program benefits the patient how to enroll Does qualify as a document requiring PAAB approval? Thank you very much in advance.
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317 - There seem to be some inconsistencies within the answers provided in this forum. In Question 313, PAAB replied that the indication does not constitute a 'claim' while in Question 303, PAAB stated that the indication is indeed a 'claim'. Could you please clarify your position. I'd argue that the indication is a claim as it refers to a therapeutic/ clinical effect.
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303 - According to the PAAB Guidance on Base Fair Balance Level Selection and Placement, the indication statement is not a 'claim' that requires fair balance. Therefore if an APS contained only the Drug name (including active ingredient and dosage form) and the indication statment, and no other explicit or implicit claims, would this APS require any fair balance? Would it be exempt from preclearance?
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277 - Assuming you can ensure that your web platform is only being accessed by Canadian physicians, what are the rules about the content that is on the website? Does the fact that the physician agrees to be "subscribe" open a channel to the information being PAAB exempt on the premise that the physician "Requested" this information? We are thinking of CME materials, disease-relation information (with and without drug mentions), videos of speaker conferences, etc.) We are also thinking of information about the sponsor's ongoing clinical trials.
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261 - A company is considering a patient support program. Before proceeding, they wish to conduct a pilot program that has been designed by an expert steering committee of specialists in the therapeutic area. Informed consent would be required from patients and the treating physician would give the information to the patient. During the course of treatment, the patient consent would include an agreement to be contacted by a PIPEDA-compliant CRO to collect information regarding the relative utility of the patient materials. The data would then be used to create the final program. The question is do the materials provided during the pilot stage need to be cleared by PAAB? It is understood that the final materials would be submitted to PAAB. Thank you for the opportunity to present this via the site. Excellent feature.
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258 - I am seeking clarification on the recent PAAB advisory Jan 10 2013. If the "Now on Formulary" has codes which we include in the announcement is this still exempt? Secondly if we include codes and incluson criteria is this exempt. Thirdly if not exempt, do we then have to have full PI accompany the Ad. The latter adds significant cost to a relatively simple message. Finally is the inclusion of details on the special authorization or codes mandatory? It would appear from your memo it is at the discretion of the company? Thank you.
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233 - Cosmetics are not in the scope of the PAAB code unless they are medicated or hypoallergenic. I assume that any medicated have a DIN or NPN. Is this also true of products with a hypoallergenic claim? We have a Cosmetic (no DIN, no NPN)in our portfolio that the company wants to detail to HCP. As such, HCP specifc promotional material is being created. Despite the fact that cosmetics without a DIN or NHP are outside the scope of PAAB, does the fact that the promotional material is directed to HCP mean it should be reviewed by PAAB or would this still fall under ASC? Thank you for your assistance.
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225 - Hello, I work for a medical communications agency. We were given a restricted educational grant to develop a program which falls under the category (as per Rx&D) 'Other Learning Program'. It follows the CME guidelines but is not accredited. The program sponsor did not have any involvement with the development of the program content. It was developed by the steering committee of specialists. The program is unbiased in nature. Treatment options for the condition in question are mentioned but not the drugs themselves. The distribution of the program will be via a direct mailer to the target audience that drives the audience to a web site where the program is housed - sales representatives are not involved in the distribution. Please confirm if this requires review/approval from PAAB.
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