Astellas in ‘unacceptable’ Xtandi ABPI code breach
pharmafile | July 3, 2015 | News story | Medical Communications, Sales and Marketing | ABPI Code, Astella, PMCPA, Xtandi
The industry code of conduct regulator has singled out Astellas for ‘particular censure’ for arranging a meeting for UK healthcare professional to promote the use of Xtandi.
It found that Astellas had breached the ABPI code by paying clinicians to attend a European meeting for urologists and oncologists that was not a ‘genuine advisory board meeting’.
An anonymous healthcare professional complained to the Prescription Medicines Code of Practice Authority after Astellas sponsored more than 100 clinicians from the UK and other countries to attend a meeting at a conference in Milan, where the company presented information on the benefits of its medicine Xtandi (enzalutamide).
The meeting was held prior to Astellas being granted marketing authorisation for Xtandi in a new indication, for the treatment of some men with metastatic castration-resistant prostate cancer.
Astellas used the meeting to seek the doctors’ opinions on how the company should market and position the drug in the UK. But the PMCPA did not see that there had been “a valid and cogent reason for holding the meeting outside the UK”.
It also noted concerns that Astellas used less than half of the total meeting time for obtaining advice and had not provided any material for reading or preparation beforehand.
“The health professionals had attended the meeting believing it was a legitimate advisory board meeting, which was not so. In addition, they had received a payment for attending a promotional meeting for an indication which at the time did not have marketing authorisation,” the Panel ruling states.
Therefore, “the Panel did not consider that the arrangements were such that the UK health professionals had attended a genuine advisory board meeting, and therefore ruled a breach of clause 2 of the Code.” This clause refers to breaches that cause discredit to, and reduction of confidence in the industry, which the PMCPA reserves “for use as a sign of particular censure”.
Given their concerns, the Panel referred the complaint to the PMCPA’s appeal board, who described paying doctors to attend a meeting on the understanding it was an advisory board was ‘unacceptable’. The Appeal Board also “questioned the rigour of the company’s processes and procedures”, adding that “improvements needed to be made and should be a priority”.
The Appeal Board ordered Astellas to issue a corrective statement to make sure all UK attendees at the meeting were aware of the breaches – and that the company had been subject to an embarrassing public dressing-down.
Lilian Anekwe
Read the full complaint and ruling here.
Related Content
FDA accepts Astellas’ sNDA for Cresemba in children
The US Food and Drug Administration (FDA) announced it has accepted Astellas Pharma’s supplemental New …
China approves Astellas’ Xtandi in non-metastatic castration-resistant prostate cancer
China’s drug regulator, the National Medical Products Administration (NMPA), has given the green light to …
FDA approves Pfizer and Astellas Pharma’s prostate cancer drug
The FDA has approved Pfizer and Astellas Pharma’s Xtandi (enzalutamide) to treat patients with a …
