AUTH/2720/6/14: Anonymous v Genzyme — discussion of Aubagio monitoring requirements (no breach) | PMCPA Case

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Key facts

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Case number	AUTH/2720/6/14
Parties	Anonymous v Genzyme
Product	Aubagio (teriflunomide)
Therapy area	Relapsing remitting multiple sclerosis
Issue	Alleged statement suggesting another hospital would use monthly (off-licence) liver enzyme monitoring rather than SPC-required fortnightly monitoring in first 6 months
Setting	Meeting with consultant neurologist and pharmacist; two Genzyme employees present
Complaint received	19 June 2014
Case completed	23 October 2014
Applicable Code year	2014
Clauses considered	2, 3.2 and 15.2
Outcome	No breach
Appeal	No appeal

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

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An anonymous complainant raised concerns about the conduct of a named Genzyme employee during a meeting with a consultant neurologist and a pharmacist to discuss Aubagio (teriflunomide).
Aubagio was licensed for adults with relapsing remitting multiple sclerosis; the SPC required liver enzymes to be assessed before treatment and monitored every two weeks for the first six months (then every eight weeks thereafter, with weekly monitoring in certain ALT elevation scenarios).
The complainant alleged that, when the health professionals raised concerns about the practicality of fortnightly monitoring, the employee said another hospital unit was “not going to follow the licence” and was looking at monthly monitoring (i.e., outwith the licence).
Genzyme investigated and gathered accounts from: employee 1 (denied saying this), employee 2 (supported the complaint), the pharmacist (supported employee 1), the line manager (did not recall off-label monitoring being raised), and an MSL (described a shared care approach intended to meet SPC monitoring requirements).
The doctor present at the meeting did not provide evidence to the Panel.
The Panel noted the parties’ accounts differed and it was impossible to determine precisely what was said; the complainant provided no further comments on Genzyme’s response.

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No breach of the Code was ruled.
No breach of Clauses 2, 3.2 and 15.2.
The Panel highlighted the difficulty of establishing what was said given conflicting accounts and limited corroboration.

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