Boehringer Ingelheim voluntary admission: uncertified Respimat e-learning went live and agency email lacked PI/obligatory info (AUTH/3205/6/19)

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Key facts

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Case number	AUTH/3205/6/19
Company	Boehringer Ingelheim Limited
Type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Issue	Uncertified e-learning published on an agency website; uncertified promotional email to health professionals lacking prescribing and other obligatory information
Material	Respimat device e-learning course; promotional email inviting pharmacists to take the course
Products mentioned	Spiolto (tiotropium and olodaterol), Spiriva (tiotropium), Striverdi (olodaterol)
Key compliance gaps	Certification missing; prescribing information missing; AE reporting statement missing; non-proprietary name not adjacent to first brand name appearance; uncertainty about content creation date
Complaint received	11 June 2019
Case completed	10 September 2019
Applicable Code year	2019
Breach clauses	4.1, 4.3, 4.8, 4.9, 14.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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Boehringer Ingelheim (BI) commissioned a third-party agency to develop an e-learning course for pharmacists about the Respimat inhaler device (used with BI respiratory medicines).
Only a ‘How to use’ downloadable PDF had been certified for website use, but the agency made the entire e-learning course live on its website before full certification.
There was confusing correspondence: BI was asked to confirm the website was ready to go live for a three-month trial; the Panel considered it was not unreasonable for the agency to think it had approval to publish the whole course.
The agency also emailed health professionals on its database promoting the course (‘How to support patients with a Spiriva Respimat Device’) without BI’s prior knowledge or approval/certification.
The promotional email omitted prescribing information and other obligatory information (including adverse event reporting statement and correct placement of the non-proprietary name next to the first brand name appearance). It was unclear whether the date shown was the date the content was drawn up.
BI identified the issue (website live status became clear on 2 April 2019) and instructed the agency to remove the website from live status the same day.

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Boehringer Ingelheim admitted breaches and the Panel ruled breaches for lack of certification and missing obligatory information.
The Panel found the e-learning content had been published prior to certification for that use.
The Panel found the agency email was promotional, uncertified, and did not meet prescribing information/obligatory information requirements.

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