GSK: MHRA references in Seretide materials and prolonged use of “new” for Avamys (AUTH/2336/7/10)

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Key facts

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Case number	AUTH/2336/7/10
Company	GlaxoSmithKline UK Ltd
Complainant	Anonymous and uncontactable medical contractor
Therapy area / products	Respiratory and allergy; Seretide, Avamys, Rupafin
Complaint received	27 July 2010
Case completed	20 September 2010
Applicable Code year	2008
Breach clauses	7.11; 9.5 (x2)
No breach clauses	4.1; 9.1; 15.2; 15.4; 15.9; 16.1
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous, uncontactable medical contractor alleged unprofessional promotional practices in GlaxoSmithKline’s respiratory and allergy therapy area.
Allegations included: (1) regular references to the MHRA in promotional materials, (2) continued use of the word “new” for Avamys for more than a year, (3) missing prescribing information on a health professional website, and (4) poor training and unrealistic targets for Rupafin leading to unethical practices.
The Panel reviewed specific Seretide items (a leavepiece and a detail aid) that cited “MHRA Drug Safety Update” in support of a claim about using a combination inhaler.
The Panel reviewed timing of Avamys promotion (started 2 February 2009) and the recall instruction email (sent 4 February 2010 at 18:29) relating to materials using “new”.
For the website prescribing information allegation, the complainant provided no examples; GSK provided screenshots showing prescribing information available via links.
For Rupafin, the Panel considered GSK’s description of representative training and the lack of evidence supporting allegations about targets and unethical practices.

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Breach found: Clause 9.5 (x2) for references to the MHRA in a Seretide leavepiece and a Seretide detail aid.
Breach found: Clause 7.11 for use of the word “new” for Avamys for more than 12 months.
No breach: Clause 4.1 (prescribing information on health professional website).
No breach: Clause 16.1 (training of representatives for Rupafin).
No breach: Clauses 15.2, 15.4 and 15.9 (targets/unethical practices allegation not evidenced).
No breach: Clause 9.1 (overall high standards).
No appeal.

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