GE Healthcare: UK-facing Vizamyl congress materials implied UK availability (AUTH/2893/11/16)

📊

Key facts

⌄

Case	AUTH/2893/11/16
Complainant	Anonymous, non-contactable
Company	GE Healthcare
Product	Vizamyl (18F flutemetamol injection); discussion also concerned unlicensed 18F flutemetamol injection
Therapy/area	PET amyloid imaging (diagnostic tool for Alzheimer’s disease)
Setting	European Association of Nuclear Medicine (EANM) meeting, Barcelona (Oct 2016)
Main issue	UK-facing congress materials implied Vizamyl was commercially available in the UK; likely led to discussion of unlicensed 18F flutemetamol
Breach clauses	Clause 3.1; Clause 7.2; Clause 9.1
No breach clauses	Clause 2; Clause 3.1; Clause 3.2; Clause 12; Clause 16
Sanction	Undertaking received
Complaint received	29 November 2016
Case completed	31 March 2017
Appeal	No appeal
Applicable Code year	2016

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

An anonymous, non-contactable complainant alleged GE Healthcare promoted Vizamyl (18F flutemetamol) and/or unlicensed 18F flutemetamol injection to UK PET centres and at the EANM congress (Barcelona, Oct 2016).
Vizamyl was licensed in the UK but not commercially available in the UK due to non-UK manufacturing sites and the short half-life of fluorine-18 (logistics meant it could not reach UK patients in time).
GE Healthcare could manufacture 18F flutemetamol in the UK, but this would be unlicensed and could only be supplied for clinical trials or as a named-patient ‘special’ (and had not been supplied as a ‘special’ to date).
At the EANM booth, some Vizamyl materials included UK prescribing information, UK price in pounds sterling, MHRA references, and a prominent UK company address.
The Panel considered this UK-facing content misleadingly implied Vizamyl was available in the UK and would likely prompt UK delegates to ask about UK access, leading to discussion of unlicensed 18F flutemetamol.
Allegations that GE Healthcare proactively approached PET centres, used disguised promotion, or failed to train staff were not supported by evidence (complainant provided no evidence and was non-contactable).

⚖️

⌄

Breach ruled: Clause 7.2 (UK prescribing info/UK pricing on congress materials misleadingly implied UK availability).
Breach ruled: Clause 3.1 (on balance of probabilities, UK delegates would have been told about unlicensed 18F flutemetamol following availability questions prompted by the materials).
Breach ruled: Clause 9.1 (high standards not maintained).
No breach: Clause 2.
No breach: Clause 3.1 and Clause 3.2 in relation to the allegation that GE Healthcare actively approached PET centres to get them to use Vizamyl by supplying 18F flutemetamol.
No breach: Clause 12 (disguised promotion).
No breach: Clause 16 (training).
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access