AUTH/1977/3/07: Pfizer v AstraZeneca – statin ‘NICE guidance’ insert and PCT guideline leaflet (Crestor)

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Key facts

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Case	AUTH/1977/3/07
Parties	Pfizer v AstraZeneca
Products	Crestor (rosuvastatin) and Lipitor (atorvastatin)
Materials	1) PJ loose insert: “The new NICE guidance on the use of statins in practice – Considerations for implementation” (“Supported by AstraZeneca”). 2) Leaflet (ref CRES10213): “Prescribing Statins – guidelines as presented by [named] PCT” (“produced and printed using a grant from AstraZeneca”).
Core issues	Disguised promotion; misleading cost comparisons and presentation; misleading safety messaging/omission of SPC conditions for rosuvastatin 40mg; missing prescribing information; inadequate copy approval and complaint investigation processes.
Applicable Code year	2006
Complaint received	16 February 2007
Case completed	21 June 2007
Appeal	No appeal. Report from Panel to Appeal Board.
Breach clauses	2, 4.1 (x2), 7.2 (x8), 7.3 (x2), 7.10, 8.1, 9.1, 9.10, 10.1 (x2)
Sanctions	Undertaking received; Advertisement; Public reprimand; Audit of company’s procedures
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth1977307-pfizer-v-astrazeneca

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

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Pfizer complained about two statin items supported by AstraZeneca (Crestor/rosuvastatin) in a competitive context with Pfizer’s Lipitor (atorvastatin).
Item 1: A loose insert distributed with The Pharmaceutical Journal (20 January) titled “The new NICE guidance on the use of statins in practice – Considerations for implementation”, labelled “Supported by AstraZeneca”.
Item 2: A leaflet “Prescribing Statins – guidelines as presented by [a named] Primary Care Trust [PCT]” (ref CRES10213), labelled “This leaflet was produced and printed using a grant from AstraZeneca”.
The Panel found AstraZeneca was closely involved (initiated the PJ piece; agency contacted authors; provided cost-effectiveness tables/data on file; reviewed for factual accuracy). The PCT leaflet was co-developed and used by representatives in a Crestor promotional call.
Key issues included: disguised promotion; misleading cost comparisons (eg omission of generic simvastatin costs in a NICE-implementation context); misleading safety messaging and omission of important SPC conditions for rosuvastatin 40mg (specialist supervision and follow-up); and missing prescribing information where the materials were deemed promotional.
Process concerns escalated: AstraZeneca’s initial responses were later found to be incorrect due to inadequate investigation; withdrawal controls were unclear; and the copy approval system was criticised.

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Breaches were ruled.
PJ insert: ruled to be promotional in effect and disguised promotion; required prescribing information but did not include it; cost and safety presentation ruled misleading in specified respects.
PCT leaflet: ruled disguised promotion; sponsorship wording misleading; missing prescribing information; multiple findings of misleading presentation of efficacy/cost comparisons and lack of balanced risk/benefit.
System-level findings: failures in AstraZeneca’s copy approval system (Clause 9.1) and conduct bringing discredit/reducing confidence in the industry (Clause 2), including concern that omission of SPC requirements for 40mg rosuvastatin might prejudice patient care.
Appeal Board: considered the matter extremely serious due to insufficient investigation and incorrect responses; required a PMCPA audit and imposed a public reprimand; requested new SOPs and implementation of audit recommendations (no further action once provided/implemented).

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