PMCPA PRESS RELEASE - Case ruled in breach of Clause 2

Angelini Pharma UK-I Limited – Case AUTH/3916/5/24

Angelini was ruled in breach of Clause 2 of the 2021 Code in relation to an in-person presentation by a contracted speaker at a company-organised promotional meeting, and its recording, which criticised the European Medicines Agency’s licensing decisions.

For that, reference to the European Medicines Agency, inadequate briefing of the speaker and lack of action to correct the speaker, and for promotion at two meetings that was inconsistent with the marketing authorisation for cenobamate, and for failing to certify the on-demand versions of two videos and 14 sets of slides (13 of which also lacked prescribing information and the adverse event reporting statement) and two on-street banners, Angelini was ruled in breach of the following clauses of the 2021 Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 5.1 - Failing to maintain high standards
Clause 8.1 - Failing to certify promotional material
Clause 11.2 - Promoting a medicine for an unlicensed indication
Clause 12.1 - Failing to include prescribing information
Clause 12.9 - Failing to include the adverse event reporting statement
Clause 15.2 - Including a reference to the licensing authority when this was not specifically required by the licensing authority

The case report is available at www.pmcpa.org.uk.

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