Astellas UK and Gedeon Richter (UK) have been named in advertisements for breaching the Association of the British Pharmaceutical Industry’s Code of Practice.
Astellas was found to have broken several clauses in the Code after a voluntary admission about its oversight of and materials produced for two patient support programmes related to Betmiga (mirabegron) and Vesicare (solifenacin succinate), which are for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as might occur in patients with overactive bladder syndrome.
Astellas explained that a member of staff searched Google for the Betmiga patient support programme and found patient support materials for Vesicare and Betmiga clearly displayed on the website of one of its agencies. The company understood that in displaying the material (without its permission), the agency’s intention was to market its abilities, led by a new creative director who was not trained on the Code.
Astellas also discovered that the agency had also used imagery from another Astellas programme which identified its medicines within the transplantation area and included product brand names and a claim. The firm considered that the use of the brand names and therapeutic indications on the agency website went beyond any requirement to market creative capabilities and constituted promotion of prescription only medicines to the public, in breach of the Code.
The ABPI’s policing arm, the Prescription Medicines Code of Practice Authority (PMCPA), concluded that in these actions Astellas was responsible for bringing discredit upon and reducing confidence in the pharmaceutical industry, thereby breaching Clause 2 of the Code.
Other breaches include: providing inaccurate and out-of-date material; describing a medicine as new for more than twelve months; describing a medicine as new for more than twelve months; and failing to disclose transfers of value on the ABPI central platform.
As a result, the firm has been publicly reprimanded on the front cover of the PMCPA May Code of Practice Review.
Gedeon Richter distributed a patient support leaflet that failed to alert women not to use any form of hormonal contraception whilst taking Esmya (ulipristal acetate), which is indicated for the pre-operative or intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
The complainant noted that any type of hormonal contraceptive, regardless of delivery route, would interfere with the efficacy of Esmya and more worryingly, birth control, leaving patients at risk of conceiving.
The company was thus also found to have breached Clause 2 of the Code, as well as giving inaccurate and misleading information (Clause 7.2) and failing to maintain high standards (Clause 9.1).
Consequently, Gedeon has been asked to issue a corrective statement to health professionals who had received the item.
Both companies have been named in advertisements, which are to appear in the British Medical Journal on 17th June, the Nursing Standard on 21st June and the Pharmaceutical Journal on 24th June.