Public reprimands and extension of Astellas’ suspension

Failure to provide accurate prescribing information

Astellas UK and Astellas Europe have each been publicly reprimanded by the Code of Practice Appeal Board for a lamentable lack of concern for patient safety and wholly inadequate oversight and control of prescribing information.

In Cases AUTH/2939/2/17 and AUTH/2940/2/17 Astellas UK and Astellas Europe had each voluntarily admitted multiple failings in relation to prescribing information: Astellas UK voluntarily admitted that there were issues with the prescribing information for seven medicines (Flomaxtra, Vesomni, Vesicare, Advagraf, Prograf, Modigraf and Mycamine); Astellas Europe voluntarily admitted that there were issues with the prescribing information for four medicines (Vesomni, Vesicare, Mycamine and Qutenza). In both cases the prescribing information had been incomplete by the omission of some adverse events and the like, for several years. The Code of Practice Panel was extremely concerned and noted that it was crucial that health professionals and others could rely completely upon the industry for up-to-date and accurate information about their medicines. Some of the matters raised went to the heart of self-regulation and patient safety. Notwithstanding the fact that Astellas UK was currently suspended from membership of the ABPI and already undergoing a series of audits of its procedures under the Code (Case AUTH/2780/7/15), the Panel reported Astellas UK and Astellas Europe to the Appeal Board.

The Appeal Board considered that these cases raised very serious matters due to the companies’ total failure to control prescribing information, the potential consequences for patient safety and the continuing nature of the failure over many years. The Appeal Board publicly reprimanded each company and also decided to require an audit of both Astellas UK and Astellas Europe’s procedures in relation to the Code to take place in October 2017. The Appeal Board reported both companies to the ABPI Board.

The ABPI Board noted and endorsed the Appeal Board’s views. It was a woeful state of affairs.

The ABPI Board gave serious consideration to expelling Astellas UK from membership of the ABPI. However, it noted the commitments from Astellas Europe, the global company and of the new UK General Manager. The companies had made voluntary admissions and it was now imperative that the October re-audits showed significant progress.

The ABPI Board decided that it would extend the suspension of Astellas UK from membership of the ABPI for another 12 months. This further period would run uninterruptedly from the initial period of suspension (from June 2016) and would then amount to the maximum suspension (two years) allowed under the ABPI Articles of Association.

The ABPI Board also decided that it wanted sight of the report of the October 2017 re-audits of Astellas UK and Astellas Europe so that it could review the position before the end of 2017. If the report of the re-audits did not show significant improvement and progress at both companies, then the ABPI Board would consider expelling Astellas UK from membership of the ABPI.

The MHRA was advised of the ABPI Board’s very serious concerns about the conduct of Astellas UK and Astellas Europe particularly in relation to the matters concerning patient safety. European Federation of Pharmaceutical Industries and Associations was also updated and asked to ensure the EFPIA Board was informed of the position.

Code of Practice Review 2017 August - Number 97