Flynn Pharma: Actiq “turn it on… and off” strapline ruled misleading (AUTH/2303/3/10)

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Key facts

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Case number	AUTH/2303/3/10
Parties	ProStrakan v Flynn Pharma
Product	Actiq (oral transmucosal fentanyl citrate)
Indication (as stated)	Management of breakthrough pain in patients already receiving maintenance opioid therapy for chronic cancer pain
Materials	Journal advertisement (International Journal of Palliative Nursing, Dec 2009; ref ACT1709) and leavepiece (ref ACT0709)
Main claim at issue	“She needs to turn it on when it starts … and off when it’s finished” with on/off control-button imagery
Complaint received	09 March 2010
Case completed	22 April 2010
Applicable Code year	2008
Breach clauses	Clause(s) 3.2 and 7.2
No breach	Clause 7.8 (photographs not ruled misleading)
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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ProStrakan complained about Flynn Pharma promotional materials for Actiq (oral transmucosal fentanyl citrate): a journal advertisement (International Journal of Palliative Nursing, Dec 2009; ref ACT1709) and a leavepiece (ref ACT0709).
Both items used the strapline: “She needs to turn it on when it starts … and off when it’s finished”, with “on” (green) and “off” (red) emphasised and accompanied by control-button imagery.
The complaint alleged the materials implied Actiq’s analgesic effect could be switched on at the start of pain and switched off at the end of an episode, which was said to be inconsistent with the Actiq SPC (including onset/measurement timepoints and pharmacokinetics such as Tmax and half-life).
ProStrakan also challenged imagery in the leavepiece showing the same woman relaxed/not in pain while using Actiq, alleging it was misleading given the 15-minute consumption period.
Flynn argued the complaint misquoted the SPC (“from” vs “at” 15 minutes) and relied on published literature to support onset/benefit; it also argued the strapline could be read as a general statement about desirable therapy attributes.
The Panel rejected the argument that published literature “took precedence” over the SPC for promotional claims and considered the strapline in context to be inextricably linked to Actiq.

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Breach upheld: the “turn it on” implication was inconsistent with the SPC particulars.
Breach upheld: the “turn it off” implication was misleading.
No breach: the inside photographs of the woman relaxed/not in pain were not ruled misleading as alleged.
No appeal.

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