Yes it is possible. Code sections 2.8, 2.8.1, 2.8.2 answer this question.
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Is it possible to provide give-aways to patients already enrolled in patient support programs? The intention is for the item to be inexpensive and provided by the HCP. Thank you.
Yes it is possible. Code sections 2.8, 2.8.1, 2.8.2 answer this question.
If an APS only includes a claim of "New Drug X" or "Introducing Drug X", is this considered exempt from PAAB review? In this instance, only the name, price and DIN of the drug would be included.
Yes. See PAAB code section 6.6(iv) for specific details.
Can you describe the patient condition, consistent with the indication in your promotional material? As an example, the patient has suffered in silence many years before seeing the doctor, tried other treatments and is now seeking help. This example would be supported by authoritative sources. If not an option in promotional APS would it be possible in unbranded APS. Thank you.
You can provide authoritative information about the disease the patient has so long as you stay within the boundaries of the indication. With regards to describing particular patients (i.e. cases), please see Q&A 469.
As an aside, I am uncertain how a message relating to individuals now seeking help would be constructive in the context of patient information as the patient, by definition, has already sought help and is either on therapy or about to embark on therapy.
Calling out the failings of other medications would not be acceptable in branded or unbranded APS.
Dear PAAB. Can sales reps distribute disease information directly to patients?
This is not recommended for prescription drugs sales reps because it is generally not considered to be ethical and it likely contravenes regulatory provisions depending on the content and context of the interaction (patient information must be non-promotional). The company can send non-promotional disease information from their medical information department to patients who specifically request it. It is the accepted role of health care professionals to distribute health and treatment related information to patients. Also see Q&A 293 & 215.
Dear Patrick, I have a question regarding references that can be used in unbranded pieces in the category of cold and flu. As you know, the active ingredients in many cough, cold & flu products have long since become generic and in fact are used across a number of different products... I was wondering if experimental studies (e.g., in vitro/cell culture/ELISA), which do not use any brand specific sources of the molecule (i.e., generic), could be used in unbranded pieces to educate HCPs on the properties of the molecule (with any necessary caveats that clinical significance cannot be determined)? Thanks!
PAAB code section 7.5 states that an editorial must have no emphasis on information specifically about the sponsor’s product(s). Using the non-proprietary name of a product does not render the APS unbranded. This is true even in cases where the ingredient relates to a component of the sponsor’s combination product.
Can an ASC approved piece be used by pharma with an HCP if it is not PAAB approved? Can it be used in the HCP office via TV screen?
The target audience and PAAB scope are central to your question. Promotion directed at HCPs falls within the scope of PAAB. Per s1 of the PAAB code, advertising provided to HCPs requires PAAB preclearance. The Health Canada document “Guidance Document - Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising” available at http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_apa-pca-eng.php only recognizes PAAB for the preclearance of HCP advertising.
For materials which will also be accessible/viewable by those visiting the clinic, please refer to the following document: http://www.paab.ca/resources/pdfs/Guidance%20for%20APS%20E%2011%2018%202009.pdf
Can branded patient brochures have the same visuals as branded physician brochures?
Please see Q&A #123.
Can a Patient Support Program be promoted to consumers? If so, would it be possible to mention features of the support program and link them to the company and the condition(s), with no mention of the products supported by the program?
We’d need additional information to answer this question. Please call the PAAB to arrange for a general question call with a reviewer.
Dear PAAB. Is it acceptable in branded APS to illustrate the patient journey using data from authoritative sources? For example, the patient has suffered for years and has tried a number of treatments before seeking medical advice. Thank you.
It is difficult to set up case studies in patient information as these tend to be inherently promotional (thus contravening PAAB s6.4.3). The PAAB website document “Guidance on Branded Patient Information” does discuss the matter of case studies. I urge you to read the case study segment and sections 1 & 2 before committing to your project. The patient information provisions were intended to enable manufacturers to create tools informing the patient about how to get the most out of the product they are taking and to inform them about their medical condition. It is not acceptable to discuss the failings of other medications.
Hi Patrick, my question is regarding the use of an economic impact study and doing a slide deck around it. Is this not PAAB exempt given that this is not about clinicals but cost savings?
Assuming the slide deck relates to healthcare products and it is directed to HCPs, it would indeed require PAAB review. Refer to PAAB code s5.10.1.ii and the website document “Guidance on Pharmacoeconomic studies” for more information. See the resources tab on our website.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de