Anonymous v Janssen: Prezista ad omitted prescribing information and implied once-daily dosing too broadly (AUTH/2433/8/11)

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Key facts

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Case	AUTH/2433/8/11
Parties	Anonymous v Janssen
Product	Prezista (darunavir)
Material	Advertisement in BHIVA Autumn 2011 conference ‘First Announcement’ booklet (ref UK/HIV/2011/0056)
Main issues	Missing prescribing information; dosing claim implied once-daily dosing too broadly; references omitted
Complaint received	22 August 2011
Case completed	04 October 2011
Applicable Code year	2011
Breach clauses	4.1, 7.2
No breach	7.4
Sanction	Undertaking received
Appeal	No appeal

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

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An anonymous, non-contactable prescriber complained about a Janssen Prezista (darunavir) advertisement (ref UK/HIV/2011/0056) placed in a ‘First Announcement’ booklet for the British HIV Association (BHIVA) Autumn 2011 conference.
The complainant said the ad contained claims without references and was misleading because it did not include Prezista prescribing information in the booklet.
The complainant challenged the claim: ‘Simple once daily dosing in both naïve patients and those switching for tolerability and convenience*’, arguing the asterisked footnote was small and the ad did not make clear that many ART-experienced patients require twice-daily dosing per the SPC.
Janssen accepted the omission of prescribing information and references was due to an administrative/process failure and that the ad was published without going through the copy approval process or being certified.

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Breach of Clause 4.1 (prescribing information missing; ad published without certification/robust process).
Breach of Clause 7.2 (misleading once-daily dosing claim; footnote qualification insufficient and claim did not stand alone).
No breach of Clause 7.4 (Panel did not accept that missing references automatically meant claims were unsubstantiated).
No appeal.

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