MHRA Charges UK Biopharma Company With Breaching Advertising Regulations
Posted 08 May 2018 | By
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) this week announced that AstraZeneca partner Leo Pharma paid nine UK-based journalists to attend an event in June 2017 and advise the company on how best to explain the benefits of the dermatology medicine Kyntheum (brodalumab), which had yet to be approved for marketing.
MHRA said it was alerted by the Irish Health Products Regulatory Agency to a media advisory board held on 26 June 2017 organized by Leo Pharma. Brodalumab was approved
in the EU for the treatment of adults with moderate-to-severe plaque psoriasis a month after the advisory board met.
And a year earlier, in July 2016, Leo Pharma was granted an exclusive license
by AstraZeneca to market brodalumab in Europe for psoriasis.
“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," MHRA said. "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 also said it considered that this advisory board was designed to promote an unlicensed medicine to journalists.
“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 said
, adding that “the non-promotional and disease-related objectives could have been achieved without reference to a specific medicine and with fewer journalists.”
Leo Pharma said it did not have any comment on the issue. AstraZeneca said it had no involvement or knowledge of the advisory board.
Editor's Note: Story updated to reflect that AstraZeneca had no involvement or knowledge of the advisory board and Leo Pharma did not have any comment.