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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.
• Jennifer Carroll -
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.
• Jennifer Carroll -
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.
• Jennifer Carroll -
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?
• Jennifer Carroll -
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.
• Jennifer Carroll -
276 - If you recorded a speaker event (sponsored dinner conference) and want to post it on a website, can you? What rules is the content subject to and what is acceptable in terms of efforts or means by which you would make HCPs aware of the availability of this recorded presentation?
• Jennifer Carroll -
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.
• Jennifer Carroll -
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.
• Jennifer Carroll -
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.
• Jennifer Carroll -
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.
• Jennifer Carroll -
219 - Hi Patrick. We're looking to place a card within packs of our prescription product, directing patients to our website. The card will contain no promotional claims. Only content would include: product and company name. Please go to www.xxxxxxxxxx.com Since the piece will essentially be part of the product packaging, I wanted to ask if this would fall under review of PAAB or HC? Also, as there are no product claims, would this be exempt from review? Thanks!
• Jennifer Carroll -
218 - Dear PAAB, We are interested in building a small electronic questionanire that reps will use to ask the doctors some questions about how they feel certain things are a problem in their practice when managing their XXX[disease state] patients? The questionnaire would be unbranded, make no mention of any treatments. Would this be considered PAAB exempt?
• Jennifer Carroll