Boehringer Ingelheim & Eli Lilly: Jardiance cardiology webcast and slides (no breach) | AUTH/3456/1/21 & AUTH/3457/1/21

An anonymous UK health professional complained about an on-demand promotional webcast and downloadable slide deck about Jardiance (empagliflozin) and cardiovascular outcomes in type 2 diabetes, hosted on a third-party website. The PMCPA Panel ruled no breach of the ABPI Code.

What happened

• A complainant challenged a third-party hosted, on-demand promotional webcast titled: “Improving cardiovascular outcomes in type 2 diabetes with SGLT2 inhibitors – What is the role of the cardiologist?”.
• The complainant alleged a statement on the webcast homepage (and in the slides) misrepresented the Jardiance SPC by including: “Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes” while citing the SPC.
• The complainant alleged the slide deck promoted SGLT2 inhibitors (and Jardiance) for cardiovascular benefits and would encourage off-label use, relying on footnotes to say Jardiance was not licensed for cardiovascular benefits.
• The complainant alleged the materials targeted cardiologists who “did not treat diabetes” and therefore would be encouraged to use Jardiance outside its licence.
• The complainant alleged outdated prescribing information (PI) was available on the website and that the material was easily accessible to the public, suggesting poor third-party oversight.
• The companies (Boehringer Ingelheim and Eli Lilly Alliance) responded that the statement was supported by the SPC (Section 5.1), the content was clearly within a type 2 diabetes context, and the outdated PI was from an expired 2017 campaign left on a server in error and not accessible via the live website.

Outcome

• No breach found for the webcast homepage statement and slide deck claims (not misleading; substantiated by the SPC).
• No breach found regarding alleged off-licence promotion; the Panel considered the content was presented within the context of treating type 2 diabetes.
• No breach found regarding outdated prescribing information being accessible via the website; it could not be accessed from the live site as alleged.
• No breach found regarding public availability; the Panel did not consider the outdated PI was easily available to the general public as alleged.
• Panel nevertheless cautioned companies to ensure unintended pages/documents are fully deleted or securely hidden and inaccessible (including via search engines), and reiterated responsibility for third parties acting on a company’s behalf.

Clauses considered

• Clause 2
• Clause 3.2
• Clause 4.1
• Clause 7.2
• Clause 7.4
• Clause 9.1
• Clause 26.1

Sanctions

• None (No breach; no additional sanctions stated).

ABPI signatory lens

• Why this matters: Even when content is ultimately found compliant, complaints can arise from (a) how SPC language is quoted/located (e.g., Section 5.1 vs 4.1), (b) how cardiovascular outcomes data is framed, and (c) residual legacy assets on third-party servers that can be discovered via search.
• Where teams slip up: Leaving expired campaign assets on third-party infrastructure; assuming “not linked from the live site” equals “not accessible”; relying on small-print footnotes without ensuring the overall impression remains within licence and context.
• Control that would have prevented it: A formal end-of-campaign decommissioning checklist for third parties (delete/redirect, confirm de-indexing where possible, verify via external search), plus periodic “open web” searches for legacy PDFs/URLs and documented evidence of removal.

What I’d check in an audit

• Certification records for the webcast and the final combined slide deck (including the October 2020 PI update and recertification).
• Evidence that the SPC citation supports the exact wording used (including when the relevant text sits in a different SPC section, e.g., Section 5.1).
• Whether the overall impression of cardiovascular outcomes slides remains within licence and is clearly anchored to the studied population (type 2 diabetes) throughout.
• Font size/legibility and prominence of any qualifying statements/footnotes, especially on summary slides.
• Third-party hosting contract/SOW clauses on content removal, retention, and post-campaign takedown obligations.
• Decommissioning evidence: confirmation of deletion of expired campaign assets from servers (not just removal of links from the live site).
• Access controls: HCP gating steps (pop-up confirmation, page headers) and whether any content could be accessed without gating via direct URL.
• “Googleability” testing: documented searches for old PDFs/URLs and remediation actions (including timelines and ownership).

What the sanctions tell you

• No sanctions were applied because the Panel ruled no breach across all cited clauses.
• Despite no breach, the Panel’s caution on deleting/securely hiding unintended pages signals that residual digital assets remain a live compliance risk, particularly with third-party vendors and search engine discovery.

3 questions to ask your team this week

• Do we have any expired campaign materials still hosted by third parties (or on our own servers) that could be found via search or direct URL?
• When we quote SPC-supported concepts that sit outside Section 4.1, do we make it easy for reviewers and audiences to see where in the SPC the wording comes from?
• For outcome-trial slides, are we consistently stating (or making unmistakably clear) the studied population and the licensed context—especially on summary/conclusion slides?

Key facts

Download the full case report (PDF)

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