AUTH/3377/9/20 - Employee v Britannia

Misleading promotion of Apo-go Pump

  • Received
    10 September 2020
  • Case number
  • Applicable Code year
  • Completed
    18 February 2021
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An employee from Britannia Pharmaceuticals Limited complained that the company’s promotion of Apo-go (apomorphine) had been misleading.

Apo-go was indicated for the treatment of motor fluctuations in patients with Parkinson’s disease who were not sufficiently controlled by oral anti-Parkinson medication.

The complainant stated that the marketing department sent a communication stating that ‘Apo-go Pump’ was non-compliant with the summary of product characteristics (SPC). The branding for Britannia’s product had been incorrect/non-compliant for years; the complainant stated that Britannia should have advertised Apo-go as an infusion and not a pump.

Britannia had misled its customers and partners and the complainant was shocked that this was not picked up sooner. How could a company promote a product when it could not get the medicine’s name correct?

The detailed response from Britannia is given below.

The Panel noted Britannia’s submission that on 13 August 2020, it was brought to its attention that the Apo-go Pump branding historically used by the company was inconsistent with the SPC. From evidence provided by Britannia, it appeared that the issue had been flagged during a recent MHRA inspection.

The Panel noted that Apo-go was supplied as a pre-filled pen for injection, in ampoules to be used for infusion or injection and in pre-filled syringes as a solution for infusion.

The Panel noted that various summaries of product characteristics (SPCs) for injection or infusion stated that the products could be administered as a continuous subcutaneous infusion by minipump and/or syringe-driver. The SPCs further stated that the choice of which minipump and or syringe-driver to use would be determined by the physician in accordance with the particular needs of the patient. Apo-go was not supplied as a pump.

The Panel therefore considered that use of the APO-go pump logo and reference to the product as Apo-go pump was misleading and inconsistent with the particulars listed in the products’ summary of product characteristics and breaches of the Code were ruled in relation to all of the affected material as acknowledged by Britannia.

The Panel noted its rulings above and that it appeared that the misleading description of Apo-go pump appeared to have been used for a long time and had not been identified by the company. The Panel noted its comments and rulings above and considered that Britannia had failed to maintain high standards and a breach of the Code was ruled as acknowledged by the company.

The Panel was very concerned about the company’s submission that its current certification system was not providing the oversight it required but further noted that Britannia stated that it sought to have fully implemented this certification system by the end of 2020, to provide the clarity and oversight of all active and inactive materials. The Panel noted that it appeared that whilst some affected material was withdrawn immediately, a number of materials, which included the misleading description and logo, were not withdrawn. The company briefing about the withdrawal of materials stated that materials featuring the Apo-go pump logo, which were designed to aid patients and health professionals, would be updated as a priority, and the current materials would be withdrawn when the company had replacements. The Panel noted that the company briefing stated that the logo was being reworked and it appeared that materials would take seven weeks to be re-issued (third week of October). Whilst the Panel was mindful of the importance of such materials for patients, it was concerned to note the length of time that the materials in question had been available. The Panel noted its comments and rulings above and considered that Britannia had failed to maintain high standards in this regard and a breach of the Code was ruled.