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Regulatory News | 28 June 2017 | By Zachary Brennan
The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety."
Astellas was originally suspended in June 2016 for deception and was re-audited in September 2016 and April 2017, which "highlighted a lack of oversight and training of agency nurses who delivered patient support programmes, including failing to update them with product changes. It is crucial that patients can rely completely upon the industry for up-to-date and accurate information.
Astellas UK and Astellas Pharma Europe also failed to update and provide complete prescribing information for many medicines – "again raising very serious concerns around patient safety and revealing multiple failings," ABPI said.
But APBI says it did not expel Astellas UK from membership because of commitments made by Astellas Pharma Europe, Astellas Global and the new Astellas UK General Manager. "The companies had made voluntary admissions and it is imperative that the October 2017 re-audits show significant progress," ABPI said.
Tags: ABPI, Astellas, prescribing information