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Regulatory News | 14 March 2017 | By Zachary Brennan
When is it OK for a pharmaceutical company to fail to quality check bags stored in a basement for three years before supplying them to pharmacies to use when dispensing the chemotherapy Navelbine (vinorelbine) to patients? Apparently never, according to Tuesday’s rundown of companies breaching the Association of British Pharmaceutical Industry’s (APBI) Code of Practice.
In addition to the basement storage fiasco for the French company Pierre Fabre, which the UK’s Prescription Medicines Code of Practice Authority (PMCPA) cited for, among other things, “bringing discredit upon, and reducing confidence in, the pharmaceutical industry,” the other breaches reveal advertising issues with Celgene, Takeda and Vifor Pharma.
In Vifor’s case, the company was cited for “producing material that caused its representatives to create doubt about the safety of a competitor product and make misleading comparisons with Ferinject (ferric carboxymaltose for injection/infusion) and for providing an unsolicited promotional email from its medical information department that was not fair or balanced about adverse reactions.”
Celgene, meanwhile, voluntarily admitted that materials released at two meetings to promote Otezla (apremilast) were in violation of ABPI’s Code of Practice for the Pharmaceutical Industry.
Also, Takeda funded an educational course in return for a health professional’s support for one of its medicines.
The PMCPA says the breaches and advertisements will appear in the British Medical Journal on 18 March 2017, the Nursing Standard on 22 March 2017 and the Pharmaceutical Journal on 25 March 2017.
Other breaches from December 2016 found by the PMCPA include those for Grünenthal, Boehringer Ingelheim, Eli Lilly, AstraZeneca UK and Janssen-Cilag.
Tags: Celgene, Takeda, Pierre Fabre, PMCPA, ABPI