pharmatimesJuly 17, 2018
Tag: UCB , PharmaMar , Yondelis , ABPI
The ABPI’s policing arm, the Prescriptions Medicines Code of Practice Authority, ruled that both companies brought discredit upon, and reduced confidence in, the pharmaceutical industry.
PharmaMar has also been publicly reprimanded and required to issue a corrective statement.
UCB was found to have breached five clauses of the Code for failing to review and re-certify materials on its corporate website aimed at the public or patients, and for "the apparently longstanding poor governance of that website".
The complaint was brought to the PMCPA by an anonymous healthcare journalist, who alleged that the section labeled ‘UCB’s product list’ on the firm’s website stated that information was ‘specific to the UK’, but mentioned several products not part of its UK’s portfolio.
The complainant also said that inaccurate, misleading information about prescription only medicines was provided to the public.
PharmaMar breached seven clauses for promoting Yondelis (trabectedin) for an unlicensed indication, disguising the promotional nature of material, making a misleading comparison and an unsubstantiated claim and failing to certify promotional materials.
The complaint was filed by an anonymous healthcare professional, who voiced concern over the off-label, early use of Yondelis, and over a number of promotional materials which they alleged had not been certified, including one which unfairly compared the drug with a competitor.
The Code of Practice Panel reported PharmaMar to the Code of Practice Appeal Board, which then publicly reprimanded the form for "failing to make any meaningful effort to undertake a thorough investigation and to provide evidence to support its position", which raised "grave concerns" about its attitude to compliance and self-regulation.
The public reprimand will appear on the front cover of the February 2018 Code of Practice Review, while the advertisements will appear in the British Medical Journal on 21st April, the Nursing Standard on 2nd May, and the Pharmaceutical Journal on 28 April 2018.
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