Astellas censured for breach of ABPI code

Astellas has been taken to task for breaching the UK pharma industry’s self-regulatory Code of Practice during an event convened to discuss its prostate cancer therapy Xtandi in Italy last year.

The censure focuses on a meeting held in Milan in February 2014, which was supposedly held to seek doctors’ advice on prostate cancer, that was attended by around 100 UK doctors.

An anonymous doctor filed a complaint with the Prescription Medicines Code of Practice Authority (PMCPA) claiming that doctors were paid to attend the event but it did not, in fact, qualify as an advisory board meeting under the code of practice and promoted Xtandi (enzalutamide) for an unapproved indication.

The PMCPA’s appeal board agreed that it was not a genuine advisory board meeting and it was ‘unacceptable’ that doctors had been paid to attend, ordering Astellas to issue a ‘corrective statement’ to all the UK attendees.

Astellas had already held two prior meetings on the same topics, according to the PMCPA judgment, and Astellas had not asked its invitees to do any reading before the event, undermining its position that it was a bona fide advisory board.

Astellas maintained that it held the conference to seek advice on how to position the medicine in the UK and located it in Milan in order to invite specialists from across Europe to one event, rather than running multiple meetings. The PMCPA panel questioned, however, whether there were valid and cogent reasons ‘for holding it outside the UK’.

The meeting promoted an unapproved use for the drug as it was held before Xtandi was approved by the European Medicines Agency (EMA) for adult males with metastatic castration-resistant prostate cancer (mCRPC) whose disease had progressed despite docetaxel therapy, according to the judgment.

However, the PMCPA ‘could not make a ruling regarding the promotion of an unlicensed indication as the relevant clause had not been cited by the case preparation manager’.

This is not the first time that Astellas has been rapped by the PMCPA for running what have been deemed to be spurious advisory board meetings. In 2010, the company was reprimanded for paying £1,000 apiece to doctors attending three meetings on its Mycamine (micafundin) antifungal product in the UK that were “at least in part disguised promotion”.

The ruling on Xtandi is the second piece of bad news for Astellas relating to Xtandi in the UK in as many months. In June, the National Institute for Health and Care Excellence (NICE) released draft guidance indicating it would not recommended Xtandi as a treatment for advanced prostate cancer as there were ‘too many uncertainties associated with the evidence provided by the drug manufacturer’.

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