Angelini rapped for criticism of EMA approval

Angelini Pharma has been taken to task under the UK pharma industry's code of practice for criticising licensing decisions made by the EU medicines regulator at one of its promotional meetings.

The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Angelini has fallen short of its standards by allowing a speaker at a 2023 meeting to disparage the EMA, questioning its competence when it came to its 2021 approval of Angelini's epilepsy treatment Ontozry (cenobamate).

Specifically, a complaint to the PMCPA from a former Angelini employee claims that the unidentified speaker – who is not from the UK – described the EU regulator's decision to approve the drug only as an adjunct to other epilepsy drugs, and not as a monotherapy, as "stupid."

It goes on to note that the company had failed to brief the speaker appropriately, made no attempt to correct the assertions made about the EMA, allowed statements to be made unchallenged over Ontozry's use as a monotherapy, and displayed materials at events in ways that breached the code in terms of promotion to the public.

The complaint further claims that when concerns were raised internally with senior management, the company failed to take action to "prevent or mitigate such actions at subsequent meetings, or to address the concerns raised around company culture and the importance of adherence to company SOPs and the code."

Angelini denied most of the allegations in its response to the PMCPA, saying it "did not proactively initiate discussion on topics outside the licensed indication for the product," but accepted that some of the speaker's comments were not appropriate for an audience that included UK healthcare professionals.

The PMCPA has ruled that the company breached no fewer than seven elements of the Association of the British Pharmaceutical Industry (ABPI) code of practice, including bringing discredit upon, and reducing confidence in, the industry.

Specifically, it upheld the complaint for the reference to the EMA, 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 Ontozry.

It also concluded that Angelini failed to certify the on-demand versions of two videos of the events, sets of slides that in most cases lacked prescribing information and the adverse event reporting statement, and two on-street banners.

Angelini has also been ordered to run an advertisement in the British Medical Journal and Nursing Standard next month acknowledging its breaches of the code.