Biogen Idec: Imraldi aRMMs sent by recorded delivery to a doctor’s home address (AUTH/3121/11/18)

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Key facts

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Case	AUTH/3121/11/18
Complainant	Health professional (hospital doctor)
Company	Biogen Idec Limited
Product/material	Imraldi (adalimumab) mailing; additional Risk Management Materials (aRMMs)
Main issue	Recorded delivery requiring signature; alleged harassment/inappropriate marketing practice; request to be removed from mailing database
Applicable Code year	2016
Clause(s) considered	Clause 9.1
Outcome	No breach
Complaint received	7 November 2018
Case completed	28 March 2019
Appeal	No appeal
Published	May 2019 Code of Practice Review

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

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A hospital doctor complained about an Imraldi (adalimumab) mailing sent by Biogen Idec to their home address which required a signature, meaning they had to collect it from a post office five miles away during office hours.
The complainant alleged this was unacceptable, an inappropriate marketing practice and constituted harassment; they said at least one colleague had also been inconvenienced.
The complainant said they had contacted the third-party mailing company (by phone and email) asking to be removed from its database and was awaiting a reply.
Biogen Idec said the pack was non-promotional additional Risk Management Materials (aRMMs) required as a condition of the Imraldi marketing authorisation and had to be disseminated to targeted health professionals before launch.
Biogen Idec said recorded delivery was used to track distribution/receipt in line with pharmacovigilance guidance (GVP Module XVI) and to evidence compliance if requested by regulators.
Biogen Idec said it was not its practice to send materials to home addresses; it confirmed with the mailing house that addresses were those provided by health professionals themselves.

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No breach of the Code.
The Panel did not consider recorded delivery of the Imraldi mailing to be inappropriate marketing practice or harassment in the circumstances.
The Panel also ruled no breach regarding the request to be removed from the mailing list because the complainant remained anonymous and did not provide details/timing sufficient to discharge the burden of proof.

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