Promotion of Fintepla by Zogenix International Limited
Published 9 June 2021
© Crown copyright 2021
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SUMMARY REPORT FOR PUBLICATION
February 2021: Promotion of Fintepla by Zogenix International Limited
Zogenix International Limited voluntarily admitted to distributing a promotional meeting flyer for fenfluramine (Fintepla) in error to UK neurologists. The MHRA were concerned that this flyer was distributed to UK healthcare professionals without appropriate review as part of the MHRA pre-vetting process.
Zogenix International Limited clarified that the flyer was reviewed and certified in accordance to their standard operating procedure (SOP). It was identified that the promotional material was not intended for a UK audience but the contact details of UK doctors were not manually removed from the distribution list as per the SOP and they subsequently received the flyer. The company have implemented an additional step in their review procedure for promotional and non-promotional communications with healthcare professionals, to ensure that these materials meet the statutory and self-regulatory requirements for the UK.