Astellas receives further year suspension from ABPI
pharmafile | June 26, 2017 | News story | Medical Communications, Sales and Marketing | ABPI, Astellas
The Association of the British Pharmaceutical Industry (ABPI) has announced that it has taken the unusual step of extending the membership suspension of Astellas Pharmaceuticals. The decision will take effect from the 24 of June 2017 and relates to a number of ‘serious breaches’ of the ABPI Code.
The drugmaker was initially suspended from the ABPI for a year following a meeting it held with doctors, in Milan, that had been held under false pretences. It was later revealed that the company had provided false information to the PMCPA in order to downplay the significance of the event.
This led to the initial one-year suspension and to the company being re-audited in September 2016 and April 2017. The audits revealed the grounds for a further year suspension, after it was found that three causes for worry were highlighted by the PMCPA.
The most crucial of which was ‘the lack of oversight and training’ of agency nurses who delivered patient support programmes. Significantly, the programmes were not updated with product changes. The ABPI noted that it had failed to update and provide complete prescribing information for a significant number of medicines. The organisation commented that Astellas’ “failure to understand the scale of the problem was concerning.”
The ABPI statement concluded with a statement by Chair of the ABPI Board, Lisa Anson, who commented: “Breaches of the Code are viewed seriously and matters concerning patient safety are of the utmost concern. The very seriousness of the matters are reflected by the extension to the suspension and the clear warning that significant improvement is required. Our industry works under strict regulations and any company that fails to meet these standards will be held accountable.”
For its part, Astellas released a statement on its UK website that read: “We deeply regret our failings, and in light of this we have reinforced our focus on patient safety. We are committed to providing the highest standards of care for everyone who relies on our medicines and services. We strongly believe in the value of ABPI membership and self-regulation and take our commitment to upholding the Code of Practice extremely seriously.”
There are further audits due for the company in October of this year, with ABPI threatening potential expulsion if adherence to its Code of Practices does not improve.
Ben Hargreaves
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