ProStrakan press release on Rectogesic: ‘aiding healing’ claim ruled inaccurate (Clauses 9.1, 20.2); no promotion breach

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Key facts

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Case number	AUTH/1892/9/06
Complainant	Member of the public
Company	ProStrakan
Material	Press release (Rectogesic) announcing purchase of worldwide rights
Product	Rectogesic (glyceryl trinitrate (GTN) rectal ointment)
Main issue	Statement implied Rectogesic aided healing of fissures, inconsistent with SPC (licensed for pain relief in chronic anal fissure)
Complaint received	29 September 2006
Case completed	7 December 2006
Applicable Code year	2006
Breach clauses	9.1, 20.2
No breach clauses	3.2, 2
Appeal	Yes – by complainant; unsuccessful
Sanctions	Undertaking received; additional sanctions not stated

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

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A member of the public complained about wording in a ProStrakan press release announcing the purchase of worldwide rights to, among other products, Rectogesic (glyceryl trinitrate (GTN) rectal ointment).
The press release stated Rectogesic was indicated for pain associated with chronic anal fissures, but also said it worked by relaxing vascular smooth muscle “aiding the healing of the fissure”.
The complainant alleged this implied an unlicensed efficacy claim (healing), as Rectogesic was licensed for pain relief in chronic anal fissures, not healing.
The contested wording appeared in the “Notes to Editors” section at the end of the press release.
The Authority also asked ProStrakan to respond regarding Clauses 2, 9.1 and 20.2 (in addition to Clause 3.2 raised by the complainant).
ProStrakan argued the press release was a non-promotional, price-sensitive investor communication (Stock Exchange/website), and that the indication was clearly stated twice.

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Breach of Clause 20.2 (information must be accurate, balanced, fair, objective and unambiguous) for the statement implying it aided healing, which was inconsistent with the SPC particulars.
Breach of Clause 9.1 (high standards) because high standards had not been maintained.
No breach of Clause 3.2: the press release was mainly financial information and did not promote Rectogesic per se, therefore did not promote an unlicensed indication.
No breach of Clause 2: the circumstances did not warrant a ruling under Clause 2 (particular censure).
Appeal by the complainant was unsuccessful; the Appeal Board upheld no breach of Clauses 3.2 and 2, and noted ProStrakan accepted the breaches of Clauses 9.1 and 20.2.

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