AUTH/3475/2/21 - Complainant v Lundbeck

Alleged promotion of Vyepti

  • Received
    15 February 2021
  • Case number
  • Applicable Code year
  • Completed
    25 August 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous, contactable complainant who described him/herself as a health professional, complained about the promotion of Vyepti (eptinezumab) which did not have a UK marketing authorisation. The US Food and Drug Administration (FDA) had approved Vyepti.

The complainant alleged that Lundbeck UK had updated the reference to the US status of Vyepti on the UK Specialist Pharmacy Service (SPS) website where launch and approval in the US for Vypeti was documented although SPS NHS was UK based. The complainant submitted that this demonstrated a clear intent in discussing the US market.

The detailed response from Lundbeck is given below.

The Panel noted the eptinezumab ‘New Medicines’ monograph on the Specialist Pharmacy Service website from the screenshot of the link provided by the complainant. It appeared that the monograph was created in June 2017 and had last been updated in November 2020. It was stated that in the UK and Europe the developmental status was ‘Pre-registration (Filed)’ and the US developmental status was listed as ‘Launched’. Key dates in the development of the medicine were noted and a brief summary of trial data was given.

The Specialist Pharmacy Service, according to its website, was described as joining together experts to create a source of impartial advice for pharmacists, GPs and clinicians to use free of charge. The SPS was commissioned and funded by NHS England and there was no mention on the website about any involvement of the pharmaceutical industry. The website included details about regional medicines optimisation committees (RMOC). It appeared from a very brief look at the website that the information for Vyepti was not different in tone or content to information for other medicines.

The Panel noted Lundbeck’s submission that it did not proactively or reactively provide input into the UK SPS website and that Lundbeck UK had never had any involvement in updating the SPS website as alleged, and this was also confirmed by Lundbeck US.

The Panel noted that the complainant bore the burden of proof and did not consider that he/she had established that, on the balance of probabilities, Lundbeck had had any involvement with regard to the SPS website. The Panel therefore ruled no breaches of the Code.