Why no ruling was made:
The subject of the complaint was a press release. As per the Health Canada document The advertising preclearance system, Health Canada adjudicates complaints related to direct-to-consumer advertising for all health products. The PAAB provides and advisory service on press releases. The PAAB adjudicates complaints pertaining to alleged PAAB Code violations in HCP advertising and patient information.

Required Action:
PAAB did not issue a required action.

Summary of key PAAB rulings in agreement with the complainant:
One of the allegations pertained to a leave behind featuring the claim that Blexten is not significantly metabolized. While the statement was consistent with the product monograph, the presentation was deemed to require addition of a disclaimer conveying that the product was nonetheless associated with risk of drug interactions from sources other than metabolization, particularly with concomitant use with P-glycoprotein inhibitors or substrates.

While the standard fair balance (elsewhere in the piece) made reference to interactions pertaining to P-glycoprotein, addition of the disclaimer in close proximity to the metabolization claim would reduce the risk that this presentation distorts the degree of risk relating to drug interactions. This disclaimer would function as "copy-specific fair balance" as it is intended to balance the particular copy that triggered the need for its insertion.

The complainant also raised allegations pertaining to two review papers distributed by the advertiser in promotional contexts. In this case, the PAAB considered the activity to potentially contravene the Food and Drugs Act. Those papers were focused on the product in which the advertiser has a vested interest. The act of distribution of those papers in a promotional context therefore risked rendering them subject to advertising regulations. This would potentially contravene the Act as they contained information which was not consistent with Blexten's product monograph.

Required Action:
For the first allegation, as the standard fair balance already made mention of the risk of P-glycoprotein interactions, and as the APS was no longer in use, no immediate action was required. Future APS containing the claim in question will require that the claim be proximally accompanied by a disclaimer as described above. For the second allegation, the advertiser was required to confirm that the two review papers in question would no longer be distributed in an unsolicited fashion. The advertiser provided this confirmation.

Summary of key PAAB rulings in agreement with the complainant:
The complaint pertained to a Simlandi leave behind which had not been reviewed by PAAB. It featured claims that the product features "reduce pain" and "promote adherence". These claims were based on a review paper. The PAAB agreed with the complainant that these claims contravened the PAAB Code as the evidentiary basis presented in the APS was insufficient. Therapeutic claims require primary evidence in the form of RCTs rather than review papers (PAAB s3.1). Additionally, such claims are required to be accompanied by data quantifying the degree of reduction along with p-value or confidence interval demonstrating that the finding was statistical significant (PAAB s4.2 and 5.9). Furthermore, these absolute claims were extrapolated from product features whose clinical significance had not been substantiated (PAAB s2.6). Finally, while the claims of reduced injection pain and promotion of adherence are not inherently comparative, the comparative context in this particular APS causes the net impression to be that Simlandi has some sort of comparative advantage in regards to injection pain and adherence versus other biologics. This is misleading in the absence of robust head-to-head RCT data supporting and quantifying the comparative therapeutic message. PAAB s5.7 & 5.10.

The PAAB agreed with the complainant that lowest level fair balance included in the APS was an insufficient disclosure level. Any APS containing therapeutic claims would require highest level fair balance. PAAB 2.4 & 3.5.

Required Action:
The advertiser was requested to confirm that distribution of the APS (if still ongoing) would cease immediately. The advertiser confirmed that the APS had no longer been in use and would not be used in the future.