Astellas Europe voluntary admission: withdrawn Xtandi digital ad still used and ‘new’ claims ran beyond 12 months (AUTH/2958/5/17)

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Key facts

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Case number	AUTH/2958/5/17
Company	Astellas Pharma Europe Limited (Astellas Europe)
Product	Xtandi (enzalutamide)
Material type	Electronic/digital advertisement (including scrolling leaderboard, expanded leaderboard, click-through page with prescribing information)
Channel/site	Medscape (website offering medical news and information for health professionals)
Issue spotted	First weekend in May 2017; escalated 8 May 2017
Voluntary admission received	23 May 2017
Case completed	17 July 2017
Applicable Code year	2016
Key claims at issue	“new indication”; “new publication” (TERRAIN study)
Indication context	Extension approved 28 November 2014; introduced December 2014
Publication context	TERRAIN study published January 2016 (Shore et al 2016)
Job bag references mentioned	ENZ/14/0077/EUd(1); XTD/15/0027/EU; XTD/16/0013/APELb (and print family including XTD/16/0013/APELc noted but not ruled upon)
Breaches	Clause 2; Clause 7.11; Clause 9.1; Clause 14.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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What happened

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Astellas Pharma Europe voluntarily admitted an electronic advertisement for Xtandi (enzalutamide) referred to the medicine as “new” more than 12 months after introduction/availability of the relevant content.
The ad was seen on Medscape in the first weekend of May 2017; the issue was escalated internally on 8 May 2017 and investigated.
The ad included the terms “new indication” (for an indication extension approved 28 November 2014 and introduced December 2014) and “new publication” (referring to the TERRAIN study published January 2016).
The digital execution comprised multiple components (scrolling leaderboard with rotating screens, expanded leaderboard, and click-through page with prescribing information) and, due to errors, pulled files from three different job bags.
A withdrawn/out-of-date scrolling leaderboard file containing “new indication” (ref ENZ/14/0077/EUd(1)) was re-linked by a publisher in November 2016 after technical issues, using files still accessible on a server hosted by a third party to Astellas’ agency.
The click-through page for mobile devices inadvertently linked to a file certified for print journal use (ref XTD/16/0013/APELb), not the intended digital file.
The intended digital job bag (ref XTD/15/0027/EU), certified 2 June 2016 and containing “new publication”, was automatically withdrawn in Zinc on 1 March 2017, but Astellas’ recall/withdrawal procedure was not followed and the agency was not instructed to remove the ad.
Astellas stated all Xtandi advertisements and prescribing information were removed on 8 May 2017; it also stated that at no time was incorrect or out-of-date prescribing information available to health professionals.
Governance issues included poor control of materials, inadequate oversight of third parties, and an expired master services agreement (MSA) with the advertising agency (expired September 2016). Astellas also stated it did not know the agency had used a third party to manage the ad server and had not given written consent for subcontracting.

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Outcome

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Breach found for use of “new indication” beyond 12 months (Clause 7.11).
Breach found for misleading “new publication” description and failure to maintain high standards (Clause 9.1).
Breach found because the advertisement subject to the voluntary admission had not been certified (Clause 14.1).
Breach found because circumstances brought the industry into disrepute (Clause 2), driven by fundamental errors, poor governance of agency/third parties, and failure to follow withdrawal/recall processes.
The Panel noted (but made no rulings on) an additional issue discovered during recall: a print ad with “new publication” ran in error in the Journal of Clinical Oncology in January and February 2017 despite cancellation instructions in November 2016.

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Astellas Europe voluntary admission: withdrawn Xtandi digital ad still used and ‘new’ claims ran beyond 12 months (AUTH/2958/5/17)

Key facts

What happened

Outcome

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