AUTH/2415/6/11: Biogen Idec—Tysabri DVD contained Xamiol (POM) content supplied to patients

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Key facts

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Case number	AUTH/2415/6/11
Parties	Director v Biogen Idec
Product/material	Tysabri (natalizumab) DVD: “A guide to MS and how Tysabri works” (TY-PAN-0177c); DVD case TY-PAN-0177d
Issue	DVD supplied to patients contained promotional material for Xamiol Gel (calcipotriol/betamethasone), a prescription only medicine
How it happened	Human error at a third-party, sub-contracted DVD manufacturer during a production run after manufacturing vendor transfer
Scale	1,015 DVDs in the affected production run; 738 in warehouse at time of recall (as stated)
Detection	Noted by a Biogen Idec representative on 9 June 2011
PMCPA clauses considered	22.1, 9.1, 2
Breach clauses	9.1 and 22.1
No breach	Clause 2
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	27 June 2011
Case completed	04 August 2011
Appeal	No appeal
Applicable Code year	2011

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

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Leo Pharma alerted the PMCPA that a Biogen Idec Tysabri (natalizumab) DVD included a 54-second clip demonstrating Leo’s Xamiol Gel (calcipotriol/betamethasone) on psoriasis.
The DVD was intended for patients who had already been prescribed Tysabri and was distributed via health professionals/representatives.
The DVD case and disc artwork were Tysabri-branded and stated: “For use only by patients who have been prescribed TYSABRI. Provided as a service to medicine by Biogen Idec Ltd”.
However, the content on the erroneous DVD contained Xamiol material only; no Tysabri information was present.
Biogen Idec said the error occurred post-certification due to human error at a third-party, sub-contracted DVD manufacturer after production was transferred to a new vendor in Q1 2011.
The erroneous run related to 1,015 DVDs; 738 were still in the warehouse. After detection on 9 June 2011, Biogen Idec initiated a recall and arranged destruction of stock and returns from representatives/clinics.
Following the incident, additional documented QC steps for electronic media manufacture were implemented (eg, folder-name screen grabs, file size checks, last-modified checks, proof approval form, and sending copies from the production run to Biogen Idec for checking).

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Breach found of Clause 22.1 (promotion of a prescription only medicine to the public).
Breach found of Clause 9.1 (high standards not maintained—insufficient quality checks on manufactured patient-directed media, especially with a new manufacturer).
No breach of Clause 2 (Panel did not consider the circumstances brought discredit upon or reduced confidence in the industry).
No appeal.

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