AUTH/3037/4/18 - Health professional v Shield

Promotion of Feraccru and unlicensed medicines to the public

  • Received
    26 April 2018
  • Case number
    AUTH/3037/4/18
  • Applicable Code year
    2016
  • Completed
    24 August 2018
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    November 2018 Review

Case Summary

An anonymous complainant who described themselves as a ‘concerned UK health professional’ complained about information on Shield Therapeutics’ website. The information in question related to Feraccru (ferric maltol), which was used to treat iron deficiency, and three pipeline products, PT20, PT30 and PT40.

The complainant noted that Shield’s website had no separate areas for different groups of people such as prescribers and the public.

Under the heading ‘lead products’ there was a section for Feraccru and the three pipeline product candidates. The information on Feraccru was clearly promotional, yet the page in question had not been screened from the public and it had no link to prescribing information for health professionals. The complainant stated that the information about the pipeline products promoted them to the public and additionally promoted such medicines before they had been reviewed by the regulatory authorities. In light of the above, the complainant queried whether the material has been adequately reviewed by Shield before it made it available on the Internet.

The detailed response from Shield is given below.

The Panel noted that the website had not been certified and therefore ruled a breach of the Code.

The page for Feraccru positioned Feraccru favourably compared to other iron therapies. The site could be accessed by the public and was promotional, therefore the Panel ruled a breach of the Code.

The failure to include the Feraccru prescribing information or a clear, prominent statement as to where it could be found was ruled in breach of the Code.

The Panel noted that unless access to promotional material about prescription only medicines was limited to health professionals and other relevant decision makers, a pharmaceutical company website or a company sponsored website must provide information for the public as well as promotion to health professionals with the sections for each target audience clearly separated and the intended audience identified. This was to avoid the public needing to access material for health professionals unless they chose to. The Panel noted its comments and rulings above. The website contained promotional material which was not directed towards health professionals and other relevant decision makers as set out in the relevant supplementary information and a breach was ruled. The Panel ruled a further breach as Shield had failed to maintain high standards. The Panel did not consider that the circumstances warranted a ruling of a breach of Clause 2 which was used as a sign of particular censure and reserved for such use.

The Panel noted its comments above and Shield’s submission that although the website was intended to be non-promotional it had become promotional. The Panel noted that the pipeline product candidate pages gave more than a brief summation of the pipeline. The section on PT20 described PT20 as novel and a more efficient phosphate binder compared to iron oxide, that it had generally good tolerability across the dose range and its absorption of phosphate in dialysis dependent CKD patients was favourably compared with the limitations of current therapies including in relation to GI side effects and significant toxicity. The Panel considered that the section on PT20 was promotional.

The Panel noted Shield’s submission that PT20 was a phosphate binder that had completed a Phase II clinical study. It was not licensed and therefore, de facto, could not be a prescription only medicine. The Code prohibited the promotion of prescription only medicines to the public. The Panel noted that the product was not currently classified as a prescription only medicine. On this narrow technical point, the Panel ruled no breach of the Code.

The Panel considered that the section on PT20, PT30 and PT40 was promotional and would generate interest in and elicit questions about unlicensed medicines. The Panel noted Shield’s submission that both PT30 and PT40 were in early clinical development. The Panel ruled that the website promoted unlicensed medicines in breach of the Code.

The Panel noted that the supplementary information to Clause 2 included promotion prior to the grant of a marketing authorization as an example of an activity that was likely to be in breach of that Clause. The Panel considered that Shield had thus brought discredit upon, and reduced confidence in, the pharmaceutical industry and a breach of Clause 2 was ruled.​