30 April 2018: Media Advisory Board for Kyntheum by Leo Pharma
Published 4 May 2018
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The Irish Health Products Regulatory Agency alerted MHRA to a media advisory board held on 26 June 2017 for Kyntheum (brodalumab) organised by Leo Pharma. Nine UK based journalists attended the event and were paid to advise Leo on securing media interest on psoriasis, its effects on patients and on Leo’s approach to disseminating newsworthy information on Kyntheum. The agenda included a presentation which featured significant content describing the benefits of Kyntheum which was yet to receive a marketing authorisation at that time.
MHRA considered that this advisory board was designed to promote an unlicensed medicine to the attendees of the advisory board. Leo Pharma agreed to issue a corrective statement to the journalists that attended the advisory board. Leo also stated that they had reviewed and improved their internal procedures to ensure compliance with the Regulations.
MHRA Advice
Regulation 279 of the Human Medicines Regulations 2012 prohibits the advertising of a medicine that does not hold a valid UK marketing authorisation.
Regulation 284 of the Human Medicines Regulations 2012 prohibits the promotion of prescription only medicines to the public.
Information on prescription only medicines which is provided by pharmaceutical companies to the general press, television or radio and press releases at the time of product launch must be factual and non-promotional. MHRA has issued guidance on press releases in chapter 7.7 of the Blue Guide and to journalists reporting on medicines in Appendix 5.
MHRA considers that advisory boards where pharmaceutical companies pay groups of journalists to listen to presentations on the potential benefits of specific prescription only medicines and encourage them to write articles about those medicines are likely to be seen as promotion of the medicines.
Leo Pharma Corrective Statement Potential breach of medicines advertising regulations: Brodalumab and Psoriasis Media Advisory Board of 26 June 2017
The MHRA has asked Leo Pharma to provide a corrective statement regarding an advisory board meeting you participated in last year.
Following a referral to the MHRA the advisory board was considered to be designed to promote an unlicensed medicine and that this therefore had the potential to lead to the subsequent promotion of a prescription only medicine (POM) to the public.
The MHRA also considered that the non-promotional and disease-related objectives could have been achieved without reference to a specific medicine and with fewer journalists.
LEO Pharma takes its responsibilities under the advertising regulations very seriously. We wish to assure you that our intention was only to seek your expert advice. We wish to assure you we had not intended that the advisory board should have any promotional elements and that we acted in good faith.