Angelini: off-label discussion at meetings, disparaging EMA comments, and portal slide compliance failures (Ontozry) | AUTH/3916/5/24 | PMCPA Case

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Key facts

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Case	AUTH/3916/5/24
Complainant	Ex-employee
Company	Angelini Pharma UK-I Limited
Medicine	Ontozry (cenobamate)
Therapy area	Epilepsy
Meetings/activities	Southern Epilepsy Forum (UK, April 2023); Cenobamate Roadshow (UK, June 2023); From Now ON (Milan, Nov 2023) including on-street banners, a day 1 presentation, and an online portal with videos and downloadable slide sets
Applicable Code year	2021
Complaint received	31 May 2024
Case completed	23 September 2025
Appeal	No appeal
Breach clauses	2; 5.1; 8.1; 11.2; 12.1; 12.9; 15.2
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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What happened

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A former employee complained about Angelini’s promotional activities for Ontozry (cenobamate) across three meeting settings in 2023: a UK meeting (Southern Epilepsy Forum), a UK “Cenobamate Roadshow” meeting, and an international “From Now ON” meeting in Milan (plus its online portal).
Southern Epilepsy Forum (UK, 21 April 2023): Q&A included discussion that went beyond the marketing authorisation, including discussion of crushing/dissolving tablets and administration via PEG feeding tubes, and references to use in non-adult populations.
Cenobamate Roadshow (UK, June 2023): complaint alleged monotherapy discussion in Q&A and lack of AE reporting; Panel reviewed the Q&A exchange provided and did not find off-label promotion established on balance.
From Now ON (Milan, Nov 2023):
- Two on-street banners outside the venue were aimed at directing HCPs; Panel considered they were promotional to HCPs and should have been certified.
- A contracted speaker delivered a short presentation criticising the EMA and advocating cenobamate as a “perfect monotherapy drug”, creating a negative impression of the adjunct-only licence.
- The same presentation was available via the event’s online platform video (Angelini initially said the EMA comments were edited out, later corrected that they were not).
From Now ON online platform (portal): UK attendees could view two videos and download 18 slide sets. The portal and multiple downloadable slide sets were not appropriately certified in their final form; many downloadable slide sets lacked UK prescribing information and the adverse event reporting statement.
Internal reporting/whistleblowing: complainant alleged concerns were dismissed; Panel did not find breaches on the evidence.

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Outcome

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Breaches found (2021 Code): Clauses 2, 5.1, 8.1, 11.2, 12.1, 12.9, 15.2 (see “Clauses” for detail and counts).
No breach findings included (among others): Clauses 3.2, 3.4, 26.1 (public advertising allegations re banners), plus several “no breach” findings within Clauses 8.1/12.1/12.9 for non-promotional slide sets.
Sanctions applied: Undertaking received. Additional sanctions: Advertisement.
No appeal.

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Clauses

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Breach of Clause 11.2 Promoting a medicine for an unlicensed indication (Southern Epilepsy Forum).
Breach of Clause 5.1 Failing to maintain high standards (on-street banners; day 1 presentation; online platform).
Breach of Clause 8.1 (x2) Failing to certify promotional material (on-street banners).
Breach of Clause 2 (x2) Bringing discredit upon, and reducing confidence in, the pharmaceutical industry (day 1 presentation and its online video).
Breach of Clause 5.1 (x2) Failing to maintain high standards (day 1 presentation and its online video).
Breach of Clause 11.2 (x2) Promoting a medicine for an unlicensed indication (day 1 presentation and its online video).
Breach of Clause 15.2 (x2) Including a reference to the licensing authority when this was not specifically required by the licensing authority (day 1 presentation and its online video).
Breach of Clause 5.1 Failing to maintain high standards (From Now ON online platform).
Breach of Clause 8.1 (x15) Failing to certify promotional material (From Now ON online platform).
Breach of Clause 12.1 (x13) Failing to include prescribing information (From Now ON online platform).
Breach of Clause 12.9 (x13) Failing to include the adverse event reporting statement (From Now ON online platform).

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Angelini: off-label discussion at meetings, disparaging EMA comments, and portal slide compliance failures (Ontozry) | AUTH/3916/5/24

Key facts

What happened

Outcome

Clauses

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