AUTH/2390/2/11: Anonymous representative v Alcon — Azarga pH demonstration (No breach) | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/2390/2/11
Parties	Anonymous representative v Alcon Laboratories (UK) Limited
Product	Azarga (brinzolamide/timolol) eye drops
Issue	Alleged unethical promotion via pH (litmus) demonstration; alleged encouragement of instillation into eyes; alleged manager instruction to “dampen down”; alleged adverse event not reported
Applicable Code	2008
Clauses considered	2, 9.1, 15.2, 15.9 and 17
Panel decision	No breach of the Code
Complaint received	21 February 2011
Case completed	27 April 2011
Appeal	No appeal
Additional sanctions	None stated

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 Alcon representative alleged unethical promotion of Azarga (brinzolamide/timolol) for glaucoma.
The complaint said reps were given litmus paper plus bottles of Azarga and competitor Cosopt to demonstrate “huge” pH differences during calls.
It was alleged reps were encouraged to instil drops into their own eyes and customers’ eyes; one doctor reportedly had an adverse event (beta-blocker intolerant) and it was allegedly not reported.
It was also alleged managers asked reps to “dampen down” the practice because competition was upset.
Alcon said the activity was a simple in-call demonstration: applying a drop of each product to pH indicator paper to reinforce the pH/comfort message in the detail aid.
Alcon stated it controlled and documented supply to the field force (approx 30 reps; 77 bottles of Cosopt supplied by Dec 2010) and said products were not intended to be left with HCPs as samples.
Alcon acknowledged some ophthalmologists might unilaterally try drops themselves, but said this was not the objective and it had no record of reps instilling drops into customers’ eyes.
Alcon instructed representatives to cease the activity pending the Panel’s ruling.

⚖️

⌄

No breach of the Code was ruled.
The Panel considered it not unreasonable for representatives to demonstrate pH differences using litmus/pH indicator paper.
The Panel found no evidence that reps were briefed to instil drops into anyone’s eyes or that they proactively encouraged ophthalmologists to do so.
The Panel found the bottles were not provided as samples to be given to HCPs, so there could be no breach regarding samples.
Because no breach was found for the substantive clauses, there could be no breach of Clause 2.

🔒

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