Novo Nordisk diabetes supplement in The Times: pre-licence promotion of liraglutide to the public

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Key facts

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Case number	AUTH/2202/1/09
Case reference	Lilly v Novo Nordisk
Complainant	Eli Lilly and Company Limited
Respondent/company	Novo Nordisk Limited
Product(s)	Liraglutide
Material/channel	16-page diabetes supplement “Changing the Future of Diabetes” distributed with The Times; article “Gut protein drug expected to help improve control”
Key issue	Pre-licence promotion/advertising of liraglutide to the public via sponsored consumer newspaper supplement; company responsibility due to editorial control
Dates (received/completed if stated)	Complaint received 23 January 2009; Case completed 10 March 2009
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clauses 22.2, 22.1, 3.1, 9.1, 2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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Eli Lilly and Company Limited complained about an article, “Gut protein drug expected to help improve control”, in a 16-page diabetes supplement (“Changing the Future of Diabetes”) distributed with The Times on 14 November 2008.
The supplement was sponsored and fully funded by Novo Nordisk and distributed to coincide with World Diabetes Day.
The article was based on an interview with Novo Nordisk’s chief science officer and described liraglutide’s putative mode of action, a “single daily injection”, and clinical trial outcomes including “better blood glucose control” and helping people “reduce weight”.
The article stated liraglutide was unapproved and “lodged with the relevant authorities in Europe and America/the US” and, if approved, expected to be available from mid 2009.
Novo Nordisk said the supplement aimed to raise awareness of diabetes and that the article presented clinical research findings, clearly indicating the product was not yet approved.
The Panel noted the sponsorship/order documentation showed Novo Nordisk had full editorial control, owned the copyright, and was part of the editorial team; there was no strictly arm’s length arrangement.
Novo Nordisk ordered 5,000 copies of the supplement; its clinical research group distributed approximately 80 copies on World Diabetes Day (no copies were distributed by sales and marketing teams).

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The Panel ruled Novo Nordisk was responsible for the supplement’s content for Code compliance because it could influence content in a manner favourable to its interests (full funding/editorial control; not arm’s length).
The Panel did not accept that the supplement was an acceptable forum to publish clinical trial results about liraglutide.
The Panel considered patients could read the article and be encouraged to ask their health professional to prescribe liraglutide, and found it irrelevant that the product was not yet available to prescribe.
Breaches were ruled for public promotion/advertising of a prescription-only medicine, pre-licence promotion, failure to maintain high standards, and bringing discredit on the industry due to lack of due diligence.

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Clause 22.2 – Breach ruled (information to the public not acceptable; considered to encourage patients to ask a health professional to prescribe).
Clause 22.1 – Breach ruled (advertising/promoting a prescription only medicine to the public).
Clause 3.1 – Breach ruled (product promoted prior to grant of a marketing authorization).
Clause 9.1 – Breach ruled (high standards not maintained).
Clause 2 – Breach ruled (failure to exercise due diligence; brought discredit upon and reduced confidence in the pharmaceutical industry).

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