Novo rebuked after diabetes promotion breaches Code

pharmafile | December 16, 2010 | News story | Medical Communications |  ABPI, ABPI Code of Practice, Grunenthal, Napp Pharmaceuticals, Novo Nordisk, PMCPA, diabetes, diabetes drug marketing, lilly 

Novo Nordisk been ‘named and shamed’ in health trade journal advertisements this week for breaching the ABPI Code of Practice.

It is one of four companies – the others are Lilly, Grünenthal and Napp Pharmaceuticals – highlighted in adverts in The Nursing Standard, the BMJ and The Pharmaceutical Journal.  

Novo Nordisk was deemed to be the worst offender, and is the only one of the four to be publicly reprimanded for multiple breaches by the Code of Practice Appeal Board.

The charge sheet is a long one and centre on the way the company promoted Victoza, including marketing the diabetes drug “on a number of occasions” before it received marketing authorisation (in breach of Code clause 3.1).

Novo also made claims and comparisons about the brand that were misleading (clauses 7.2 and 7.3), disguised promotional material (12.1) and failed to provide information which reflected available evidence (7.9).

Novo Nordisk was also cited under clauses 2 (bringing discredit on, and reducing confidence in, the pharma industry) and 9.1 (failing to maintain high standards).

As if that weren’t enough, a separate case found Novo Nordisk guilty of failing to comply with an undertaking not to use material previously ruled in breach of the Code (contravening clause 25).

It was also deemed to have “provided inaccurate information in that undertaking”, so was found in breach of clause 2 (discredit on the sector) and clause 9.1 (regarding high standards) again.

Lilly fell foul of clause 3.1 – ironically after a complaint from Novo Nordisk – with a presentation about its own diabetes treatment, Byetta long-acting release for once weekly dosing, which does not have marketing authorisation.

For this, it was also found in breach of clause 7.2 (making misleading claims) and the catch-all clauses 2 and 9.1.

Grünenthal’s promotion of an unlicensed indication (clause 3.2) for pain brand Versatis in the poster session of a meeting of the British Pain Society, and cost comparisons for the drug which were incorrect and misleading (clause 7.2), also breached clauses 2 and 9.1.

Finally, the Prescription Medicines Code of Practice Authority (PMCPA), which enforces the Code, took a dim view of Napp’s provision of business class air travel to 17 delegates to attend an international congress in Montreal.

As well as clauses 14.2 (failing to certify overseas travel) and 19.1 (providing excessive hospitality) the company was also cited under 2 and 9.1.

The PMCPA always advertises details of firms in breach of clause 2, or which are publicly reprimanded.

Adam Hill