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For a prescription product, the linkage of the therapeutic use in the URL and the brand on the landing page would exceed the consumer advertising restriction of name/price/quantity in the Food and Drug Regulations Section C. 01.044. This linkage would also not be appropriate for a non-prescription product indicated for the treatment of a schedule A disease as per section 3 of the Food and Drugs Act. For a product branded landing page, a simple solution is to use the URL www.productname.ca
Under the July 2013 PAAB code:
A piece containing only product logos (without taglines or other explicit/implicit product messages) + the corporate message "[Company] committed to gastrointestinal care for over 80 years" would not require fair balance. The piece would be reviewed under section 7.4. A piece containing only a product claim of "10 years of experience" would require the lowest level fair balance.
That specific provision is simply meant to convey the following: The relevant indicated use must either appear in the PRO claim or in the context leading into it. The overall message should convey that the PRO outcome is secondary to management of the indicated use (rather than a separate product use). For example, the journal ad headline "Product X demonstrated improved QOL versus placebo" should actually read "In the management of MDD, product X demonstrated improved QOL versus placebo". That provision should be interpreted in the context of all other relevant provisions. As an aside, note that acronyms should be defined.
The PAAB's primary role is to ensure that healthcare product communication for prescription, non-prescription, biological, homeopathic and natural health products is accurate, balanced and evidence-based, and reflects current and best practice. The PAAB also monitors trends in health product advertising and promotion and adjusts its code and practices as required to fulfill its mandate. PAAB monitors healthcare product advertising directed to health care professionals as per PAAB code section 10. PAAB also adjudicates stage II complaints on healthcare product advertising directed to health care professionals as per PAAB code section 9.
The scope of the PAAB includes promotional healthcare product communication for prescription, non-prescription, biological, homeopathic and natural health products to health care professionals in all media. PAAB also provides advisory comments on direct-to-consumer materials for prescription drugs. PAAB's Scope evolves with the regulatory framework.
Please visit our website at www.paab.ca for more information and don't hesitate to call us at (905) 509-2275 if you have any questions. Also find us on LinkedIn, join the PAAB group and participate in the discussion!
Yes. PAAB has considered this. You'll note that complexity of HCP advertising review is at the core of most concerns. But I'd like to raise an ethical concern first. Specifically, creation of two separate fee streams may accentuate imbalances in the market place (e.g. smaller manufacturers & agencies may find it harder to access the priority stream due to budgetary reasons). Fairness is an important ingredient for a healthy preclearance system.
I am uncertain what benefit the proposed system would have above and beyond the existing system if access to the priority stream was limited to APS which are simple and short. PAAB already does what it can to expedite such files when client expressed needs intersect with PAAB capacity to help. Under the proposed system, I suppose we'd need to ignore all requests for rushes in the regular stream as accommodating such requests would be unfair to those who paid extra for that privilege. This also leads to other interesting questions like "What happens when the regular fee stream is below day 10?"
For example, I suspect it would appear unfair for your competitor to have received a day 6 response on the regular stream ($450) if you've paid $2000 to receive your response on day 5. It would be hard for clients to assess the cost-benefit of paying extra unless the size of the "benefit" was static/fixed. Would this mean that, when the priority fee was not paid, the PAAB could not respond until day 10 (even if the review was completed long before day 10)? Say the turnaround times were not static/fixed, wouldn't stakeholders come to suspect that reviews for the regular stream are intentionally slow so as to induce clients to pay the higher rate for the priority stream?
In my experience, most projects are "priorities" by the time they are submitted for PAAB pre-clearance. The complexity of HCP advertising review would make it difficult to deliver on the priority commitment. This means that additional staff would be required (which further adds to complexity as the specific number of staff required would be difficult to forecast and the training period is such that it takes at least 6 months before new staff contribute in a meaningful way). If most projects go into the priority stream, the proposed structure essentially acts as a sizable fee hike. Note that a shortened first response time does not necessarily equate to a fast approval. Other key factors include how long revisions stay on the agency/manufacturer end before getting sent back to PAAB and how many rounds of revisions are required. Client efficiency is a key determinant of how long the file stays on the client end, while response quality is a key determinant of how many rounds of revisions are required to get to approval. Ultimately, it may be worthwhile for our clients to consider whether their interests are best served by investing in their own internal processes rather than the proposed system which essentially adds up to buying a few days on the PAAB end.
Unless we have at least 30 attendees it is not cost effective to conduct an open course outside the PAAB office. We are going to develop a webinar in the near future. Stay tuned.
I'll assume that the a pilot is intended simply to evaluate the program's impact, benefits and weaknesses before implementation. I'll also assume that good market research practices will be followed.
A pilot should not be intended to promote the sale or disposal of medication. In that vein, it must have a small controlled scale (e.g. short term & low number of test cases). Provided the size and duration are the minimum required to contemplate the program, the pilot does not require review. Long duration or large scale may render the pilot promotional (thus disqualifying it from preclearance exemption).
Note that the program will require review if the decision is made to implement it. Even when the pilot does not require review, it is advisable to submit it for pre-clearance if you are concerned about consistency of message between the pilot and implemented program. The pilot may have little value in predicting impact/benefits/weaknesses if it is significantly different from the eventual approved/implemented program.
The link to the registration page is at the extreme bottom of the following webpage: http://www.paab.ca/events/#newpaab
Are there any guidelines (outside of color preference) for placement of the PAAB logo on an approved piece? Is there a size limitation of the logo or a desired location (front vs. back side) we should consider? The website is not loading the PAAB logosheet PDF unfortunately?
Currently, the PAAB logo must appear in both the display and PI sections of the advertisements as per PAAB code section 8.5(b). After the PAAB code change, the logo need only appear on the display section of the advertisement. The code is not prescriptive with respect to placement and size. The manufacturer should ensure that the logo is easily identifiable.
The logo is available at the following web-link: https://www.paab.ca/resources.htm#category=PAAB-Icons&category_id=5
I was able to open the logo/icon documents. The problem may have been temporary. Please call the PAAB office if you have any difficulty opening these documents.
PAAB Code section 2.1 states that advertising material must be accurate, complete and clear and designed to promote credibility and trust. We've been informed by provincial bodies that a formulary message containing coverage codes without also stating the covered use is incomplete and therefore violates the spirit of PAAB code section 2.1.
Promotion of coverage codes must be accompanied with complete presentation of the corresponding coverage criteria. This means that when the coverage has limitations/exceptions, the manufacturer has the discretion to choose one of the following alternatives:
Note: ALL post-approval changes involving the addition or modification of ANY formulary statements must be submitted for review as new files complete with the formulary references. Such post-approval changes are not accepted as FYI's.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
