Bristol-Myers Squibb voluntary admission: amended Opdivo/Yervoy promotional article republished online before certification (AUTH/3286/12/19)

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Key facts

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Case number	AUTH/3286/12/19
Company	Bristol-Myers Squibb Pharmaceuticals Limited
Case type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Issue	Failure to certify advertisement / final form not checked and signed; amended online article republished before certification
Product(s)	Opdivo (nivolumab) and Yervoy (ipilimumab)
Therapy area / indication mentioned	Renal cell carcinoma
Material / channel	Promotional article in Urology News (online and print)
Complaint received	12 September 2019
Case completed	2 November 2020
Applicable Code year	2019
Breach clauses	9.1, 14.1
No breach clauses	2
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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During responses to an earlier case (AUTH/3241/8/19) about incorrect overall survival data in a Urology News promotional article for Opdivo (nivolumab) and Yervoy (ipilimumab), Bristol-Myers Squibb (BMS) identified additional process failures.
BMS found an amended (corrected) version of the article had been republished online before it had been certified.
BMS asked the communications agency to remove the amended, uncertified online version.
For print, BMS stated that neither the original nor the corrected version was sent in its final form for check and signature before publication (hardcopy final form not checked/signed).
BMS said both versions had been certified within its electronic approval system with electronically signed certificates, but the final published forms were not properly certified/checked as required.
The voluntary admission was treated as a complaint under Paragraph 5.6 of the Constitution and Procedure.

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Breach of Clause 14.1 was ruled (failure to certify as required).
Breach of Clause 9.1 was ruled (high standards not maintained, given repeated certification failures and failure to adhere to SOP).
No breach of Clause 2 was ruled (Panel did not consider the circumstances warranted particular censure).
No appeal.

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