Bayer voluntary admission: uncertified Levitra symposium invitation sent to UK recipients (transparent envelope, missing PI, unapproved strapline)

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Key facts

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Case number	AUTH/2469/12/11
Company	Bayer
Type	Voluntary admission
Material	Symposium invitation (4-page A5)
Product	Levitra (vardenafil) ODT
Event	Satellite symposium at ESSM Congress, Milan (Dec 2011), titled “Men’s changing sexuality, identity and behaviour”
UK recipients	Seventy four invitations sent to UK delegates
Main issues	Not UK-certified; missing prescribing info; missing AE reporting statement; generic name not adjacent to prominent brand; unapproved/inconsistent strapline; transparent envelope exposing branding; sent to some non-HCPs
Complaint received	22 December 2011
Case completed	13 February 2012
Applicable Code year	2011
Breach clauses	3.2, 4.1, 4.3, 4.10, 9.1, 9.8, 14.1, 22.1 (x2)
Clause 2	No breach
Appeal	No appeal
Sanctions	Undertaking received (additional sanctions: Not stated)

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

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Bayer UK voluntarily informed the PMCPA that a Bayer global (Berlin) invitation to a Bayer-sponsored satellite symposium at the European Society for Sexual Medicine (ESSM) Congress (Milan, Dec 2011) breached the Code.
The 4-page A5 invitation prominently featured the Levitra (vardenafil) orodispersible tablets (ODT) logo and promoted Levitra.
Bayer global did not treat the invitation as promotional material and therefore did not follow the relevant SOP; UK review/approval was not obtained and the material was not certified for UK use.
Seventy four invitations were sent to UK delegates registered for ESSM.
The invitation omitted required prescribing information and other obligatory information, including an adverse event reporting statement.
The non-proprietary name (vardenafil) was not placed adjacent to the most prominent display of the brand name on the front cover.
A strapline stated: “First-line ED therapy he can take anytime, anywhere” (not approved for UK use and inconsistent with dosing limitations).
Invitations were mailed in transparent envelopes, allowing the public to see the Levitra logo and infer sexual health use.
Some invitations were sent to individuals Bayer understood were not health professionals (employees of another pharmaceutical company and an events agency), and not appropriate administrative staff.

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Breach found for: Clauses 3.2, 4.1, 4.3, 4.10, 9.1, 9.8, 14.1, and 22.1 (Clause 22.1 breached twice).
No breach of Clause 2 (the Panel did not consider the circumstances warranted the particular censure associated with Clause 2).
No appeal.
Sanction recorded: Undertaking received.

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