Note from the Commissioner

In contrast to many news media reports about 2016 being generally bad, it was a very good year for the PAAB. In 2016 we celebrated 40 years of PAAB preclearance review of advertising to support the pharmaceutical industry to create ethical drug advertising. We thank the many people who attended the celebration at our golf tournament at Coppinwood Golf Course. We are thankful for their appreciation that ethical drug advertising is a good thing to celebrate. Special kudos to Jennifer Carroll and Laurie Johns for their creativity and hard work to make the day enjoyable for all.

In 2016, we had a high review volume of 7500+ first reviews, second highest in the history of the PAAB. The staff handled the review volume very well with 99% of the reviews completed within the required standards set by the PAAB. We have a staff of 21 people now with 14 of them being reviewers.

We implemented some improvements in phase two to the Efiles system, helping the review efficiency to improve. We introduced the manufacturers dashboard to help sponsors track their own files to improve their awareness of the review process. We also introduced the ticketing and tagging system to address issues that were raised in the initial independent audit of the PAAB review system. This allows both clients and reviewers the ability to tag comments about what is happening real time during the review process. This will help us to improve the PAAB review mechanism down the road.

The code committee met 11 times to reach a final draft which is out for consultation with our board members. We hope to have a vote on April 21 and implementation on January 1, 2018. Stay tuned for more info on that.

We had two successful PAAB Code training events in November with 430 people attending. We followed that up with the PAAB Code Game, a digital experience to test your knowledge of the PAAB Code, powered by Facilica and supported by 42Comets. We thank Yves Bordua for his support and congratulations to all who participated.

We continued our communications plan to keep our stakeholders informed about PAAB activities and news through newsletters, LinkedIn, Twitter, webinars, surveys and email blasts.

We lost two longstanding PAAB staff in 2016, Glenn Golaz and Chris Seto. We replaced them with Patrick Marshall, Robert Marsala and John Greiss. The reviewers work very well as an efficient team under the guidance of Deputy Commissioner Patrick Massad.

The board was busy as well with 3 meetings in 2016 plus a strategic planning session at the end of November. We will publish the goals of the plan when we get the final report.

All in all, it was a very good year with a lot accomplished by the PAAB staff and board of directors. We thank our clients for their continued support of the PAAB through 40 years.

Sincerely,

Ray Chepesiuk

PAAB Commissioner

Stage Two Decisions

1. ADVERTISER:  Ethical Remedies              
COMPLAINANT:  Biosyent
SUBJECT:   c16-03 EBMFer (NPN80042242) APS
PRECLEARANCE: No  
ALLEGATIONS:

The claim to superiority in the promotion piece is a hanging comparison, which is an implicit comparison to all other iron products used for iron-deficient anemia (IDA), including FeraMax® 150. The absence of an express reference to the brand is irrelevant and is not a legitimate defence.
•               Second, ER admits, in its response, that absorption data is not relevant to the question of clinical efficacy. It notes, specifically, that: “It’s important to note that there has been no effort in the literature to link absorption with clinical efficacy in IDA …”. ER effectively admits that its absorption claims serve no legitimate purpose. They are used in the promotional piece to impliedly suggest that EMBFer™ has superior efficacy due to its allegedly superior absorption. 
•               Third, as was previously noted, ER does not have any studies or literature that supports the claimed 40% absorption figure in connection with the EMBFer™ formulation itself. ER response does not provide any authoritative data in support of such a cross-reference claim.
 
DECISION: While we do not agree with all the Biosyent allegations, a PAAB review of this APS reveals the following:

• The heading is superlative, absolute, and hanging.
• In the context of a branded piece, claim “Ferrous Ascorbate has superior absorption ie >40%” along with the histogram depicting the absorption levels from the three studies suggests that this information is somehow relevant to the sponsor’s brand. Although this is supposedly intended to convey information about dietary sources, this is not clear in the copy. More importantly, even if it were clear in the copy, the presentation would be incomplete unless the absorption of the ER products were included (along with a disclaimer that the clinical significance is unknown).    
• It is still unclear whether the reference 4 study evaluates specifically to the sponsor’s brand. This would be required as ingredients other than the iron salt may influence absorption.
• The piece has no indication or fair balance. 

 
Thus this APS would be in vilation of the PAAB Code of Advertising Acceptance and possibly the Food &Drugs Act containing potentially misleading information.
 
Summary and Penalty
Because the APS is in volation of the PAAB Code it should not be used for promotional purposes.  Ethical Remedies states that it has not been used for one year.  The PAAB would like to see some proof that the material has been retrieved from sales reps (a letter to sales reps requesting that would be sufficient) and attestation that it will not be used in future.
 
OUTCOME: Ethical Remedies complied with the PAAB.

2. ADVERTISER: Searchlight Pharma         
COMPLAINANT:  Novo Nordisk
SUBJECT: c16-04  Estragyn leave behind
PRECLEARANCE:  No 
ALLEGATIONS:

1. The Price Chart constitutes off-label promotion and is misleading because the price of Estragyn® Vaginal Cream is promoted at a dose outside of the approved indication and promotion in this manner makes it appear that the Product is the cheapest local estrogen treatment available. The Estragyn® Vaginal Cream product monograph (Appendix II ) states that "the recommended dose is 2.0 to 4.0 grams per day taken intravaginally". However, the Price Chart advertises the price at a dose of 0.5 grams taken 2-3 times per week.  
2. The Price Chart uses outdated and misquoted statements from the North American Menopause Society ("NAMS") regarding Estragyn® Vaginal Cream.In its most current version, the 2013 NAMS Position Statement on the management of symptomatic vulvovaginal atrophy (AppendixIV), the recommended dosage for Estragyn® Vaginal Cream is consistent with Searchlight Pharma's terms of market authorization:  2-4 g per day, intended for short-term use; progestogen recommended.  
3. The Price Chart fails to disclose that an appropriate dose of progestin is required when Estragyn® Vaginal Cream is prescribed to women with intact uteri to prevent endometrial hyperplasia/carcinoma.

 
DECISION:
Allegation 1 – I agree with Novo Nordisk.  The Price Chart indeed contains off-label claims related to a dose outside of the approved indication and promotion in this manner makes it appear that Estragyn Vaginal Cream is the lowest cost local estrogen treatment available. This is a violation of PAAB Code s2.1 and 3.1.

Allegation 2 – I agree with Novo Nordisk.  The NAMS statement is out of context and outdated with this APS and is not consistent with Estragyn Vaginal Cream TMA. This is a violation of PAAB Code s3.2.
 
Allegation 3 – I agree with Novo Nordisk that an appropriate dose of progestin is required when Estragyn Vaginal Cream is prescribed to women with intact uteri to prevent endometrial hyperplasia/carcinoma in accordance with the TMA.
 
It appears to me that this APS was possibly created by contracted employees of Searchlight Pharma and Searchlight Pharma officials should do everything possible to recall the material, stop further distribution and train its employees on truthful, ethical promotion.
 
PENALTY:This APS has several violations of the PAAB Code of Advertising Acceptance.  Searchlight Pharma has an obligation to control the activities of its contracted sales reps.  Therefore I would like to see proof the actions taken by Searchlight Pharma with respect to controlling the activities of their sales reps and copies of any messages sent to those employees (confidential to PAAB).  I also remind Searchlight Pharma of the availability of the PAAB preclearance review service.
 
OUTCOME: Searchlight Pharma complied with the ruling
 
3. ADVERTISER:  Vanc Pharmaceuticals               
COMPLAINANT:  Tribute Pharmaceuticals
SUBJECT:   C16-08 Hema-Fer Promotional Materials
PRECLEARANCE:No   
ALLEGATIONS:
1.The objectionable claims made by Vanc relates to the type and quantity of iron in a single tablet of Hema-Fer^TM . These objectionable claims are evident in Vanc's detail aid (See Appendix 3) titled "Hema-Fer^TM Heme Iron Polypeptide". This piece was published and/or distributed by Vanc to health care professionals.

This detail aid includes information which purports to show that the iron absorbed from Hema-Fer^TM is Heme-lron Polypeptide (HIP). It also shows that Hema-Fer^TM has been approved for the prevention and treatment of anemia and iron deficiencies. The information Vanc presents in the detail aid does not appear in the terms of marketing authorization or the product license for Hema-Fer^TM

1.   Please be advised that Aralez Pharmaceuticals has also submitted a "Trade Complaint" to Health Canada regarding the following concerns:

a. Aralez Pharmaceuticals has conducted testing on Hema-Fer tablets and the results have indicated that each tablet contains 0.36 mg of Heme Iron Polypeptide and not 12 mg as is indicated on the product label for Hema-Fer. This is in contravention of the Food and Drugs Act hence the notification to Health Canada.
b. The product labels for Hema-Fer indicate that the recommended use is for ^uthe prevention and treatment of anemia and iron deficiencies". This is incorrect as the product license for Hema-Fer was authorized by Health Canada based on Vanc's attestation to meeting the claims of NHPD's Iron Monograph. The Iron Monograph does not list the "treatment" of anemia and iron deficiencies as one of it acceptable claims. It lists the "prevention" of anemia and iron deficiencies is acceptable. Again, Vanc has contravened the Food and Drugs Act by including a claim on the label that is not authorized by Health Canada.
c. The NHPD Iron Monograph includes a list of the types of irons that are acceptable and to which Vanc has attested to. This list does not contain Heme Iron polypeptide. Therefore, this is another contravention of the Food and Drugs Act.

2.    Vanc's first misrepresentation is in falsely claiming that each tablet of Hema-FerTM contains 12 mg of Heme Iron Polypeptide.

As already noted, the Health Canada Hema-Fer^TM approval is as authorized in the NNHPD Iron Monograph. This monograph indicates the type of iron that the Hema-Fer^TM tablets may contain (See Appendix 2, Iron Monograph- Source Material section). Heme Iron Polypeptide in not listed in the Iron Monograph (See Source Material Below), hence Vanc advertising Hema-Fer^TM as containing Heme Iron Polypeptide, is in direct contravention to the "TMA" or product license.

For Vanc to be compliant with the ^UTMA" they would not be able to advertise that the medicinal ingredient is iron as Heme Iron Polypeptide. They would only be able to use one of the Iron sources mentioned in the Iron monograph.

Thus, if Vanc were being compliant with the PAAB code and the Food and Drugs Act, they would not knowingly and falsely represent that Hema-Fer^TM has obtained a product license authorizing that it contains Heme Iron Polypeptide. This shows that honest advertising is clearly not Vanc's objective given their blatant disregard for regulatory authorities.
Vanc's misrepresentation is in falsely claiming that Hema-Fer^TM is indicated for the prevention and treatment of anemia and iron deficiencies.

As already noted, the Health Canada "TMA" or prod uct license indicates that the recommended use of Hema-Fer^TM is as authorized in the NNHPD Iron Monograph. This monograph indicates the recommended uses for which Hema-Fer^TM can be used (See Appendix 2, Iron Monograph- Use or Purpose Section). As per the figure below, Hema-Fer^TM is not authorized to be used for the "treatment" of anemia or iron deficiencies. It can only be used to "prevent" iron deficiencies or anemia.

Thus, if Vanc were being compliant with the PAAB code and the Food and Drugs Act, they would not knowingly and falsely represent that Hema-Fer^TM has obtained a product license authorizing that it treats anemia and iron deficiencies.

In view of the foregoing, it is clear that Vanc in not carrying out advertising that is accurate, balanced or that is in accordance with the "TMA" or product license for Hema-Fer^TM .

Hema-Fer's promotional activities and materials violate a number of sections of the PAAB Code, including s1.1, 2.4, 2.6, 3.1, 5.6, 5.7, 5.10, 5.15, 5.16.
 
DECISION: We agree with most of the allegations lodged by Tribute.  If PAAB did do a review we would ask for cover to cover revisions. In particular, allegations include:

1. Promotion with off-label claims.
2. Claims of absolute efficacy unsupported by clinical evidence.
3. Lack of fair balance safety information necessary for iro products.
4. Drug content of Hema-fer that is not consistent with approved TMA.
5. Misrepresentation of active ingredient and HC approved indication.
6. Violations of PAAB Code s1.1, 2.4, 2.6, 3.1, 5.6, 5.7, 5.10, 5.15, 5.16.

 
OUTCOME: Tribute has provided a request for activities that should be undertaken by Vanc to correct this advertising.  Vanc has fully cooperated with the PAAB request for acknowledgement and correction for future advertising. Also, VANC had provided testing report of Hema-Fer which is in compliance with their label claim for iron content.
 
Therefore, I am requesting that Health Canada expedite a review of this complaint and bring appropriate enforcement action versus Vanc. In future, we suggest that all companies use the PAAB preclearance mechanism to avoid this need for regulatory enforcement.


4. ADVERTISER: Pierrel       
COMPLAINANT: Septodont C16-06
SUBJECT:   C16-06 Orabloc ad in Oral Health
PRECLEARANCE: No  
ALLEGATIONS:
2.4, no fair balance, 2.6 superlative claims unsubstantiated

DECISION:
1.  General Impression:  We agree there is not appropriate fair balance safety information and there should be a link to the full TMA.
2.  The claim “The quality that you need, the Price that you want” is an unsubstantiated superlative.
3.  The claim “Only 10% Overage of epinephrine” is an unsubstantiated link of safety to the dosage form concentration and is an unsubstantiated claim of superiority.
OUTCOME:Health Canada informed. Pierrel responded and complied to revise the APS and use the PAAB preclearance review mechanism.


 

New PAAB Guidance Documents added to the website

 
Since the previous newsletter, the following guidance documents have been added to the
PAAB website:
 
Guidance on indication and fair balance font size
This document is meant to provide you with some guidance on acceptable font size and
general type legibility…
Read more
[links to]:
http://www.paab.ca/Indication_and_Fair_Balance_Font_Guidance_-_Final_Draft.pdf
 
Guidance on eFiles Ticketing and Tagging 
There are two types of instances in which you’ll want to create a ticket…
Read more
http://www.paab.ca/Guidance_on_eFiles_Ticketing.pdf
 
Here is a complete list of all other advisories, guidance documents, and reviewer tip
documents added to the PAAB website throughout 2016:  

• Guidance on Advertising for Drugs with Notice of Compliance with Conditions (NOCc) [links to]:

          http://www.paab.ca/Guidance_on_Advertising_for_Drugs_with_Notice_of_
          Compliance _with  _Conditions_(NOCc)._September_2016._pdf.pdf

• HCP and Patient Targeted Risk Minimization Tools (RMTs) [links to]:

          http://www.paab.ca/Guidance_on_Risk_Managment_Tools_
          (September_2016).pdf

•  Advisory regarding use of RAMQ in APS [links to]:

           http://www.paab.ca/Advisory_regarding_use_of_RAMQ_in_APS.pdf
 

• Subjective vs objective endpoints [links to]:

          http://www.paab.ca/Review_Tips.__Subjective_vs_objective_endpoints_
          (September_2016)_(002).pdf

• APS Checklist  [links to]:

          http://www.paab.ca/The_APS_checklist_doc_-__Mar_1_(002).pdf

• References Checklist  [links to]:

          http://www.paab.ca/References_Checklist_-_Feb_2016.pdf

• Tip relating to inclusion of expert commentary in drug advertising [links to]:

          http://www.paab.ca/Tip_relating_to_inclusion_of_expert_commentary
          _in_drug_advertising.pdf
 
 
It’s been yet another busy year of posting new guidances to help our clients navigate the approval process. If you missed any of these and you’d like to know as soon as new documents are posted, follow us on Twitter @ThePAAB.