AUTH/3639/4/22 - Complainant v Roche Products

Allegations about a Polivy promotional website

  • Received
    25 April 2022
  • Case number
  • Applicable Code year
  • Completed
    24 April 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case was in relation to allegations that the dosing page of the Polivy (polatuzumab vedotin) promotional website missed important administration instructions included in the Polivy summary of product characteristics (SPC) that were required to ensure patient safety.

The Panel ruled a breach of the following Clauses of the 2021 Code because the dosing webpage, which was intended to advise health professionals on the appropriate administration of the medicine, gave the misleading impression that it contained all the important information health professionals needed to administer Polivy, which was not so in respect of specific instructions about a particular infusion line and dose modifications in the event of an infusion related reaction:

Breach of Clause 6.1

Providing misleading information

Breach of Clause 5.1

Failing to maintain high standards

Breach of Clause 2

Bringing discredit upon, and reducing confidence in, the
pharmaceutical industry

The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that:

• health professionals were unlikely to be misled about the route of administration for Polivy (i.e. that it was to be administered as IV infusion and not IV bolus or push)
• there were no allegations that information was not capable of substantiation
• dose modifications information in relation to an infusion-related reaction was provided on the safety webpage:

No Breach of Clause 6.1

Requirement that information must not be misleading

No Breach of Clause 6.2

Requirement that information must be capable of substantiation

No Breach of Clause 5.1

Requirement to maintain high standards

No Breach of Clause 2

Requirement that activities or material must not bring
discredit upon, or reduce confidence in, the
pharmaceutical industry

This summary is not intended to be read in isolation.
For full details, please see the full case report below.