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Pharmaceutical company suspended by trade group over 'deception'

Published 25/06/2016

Astellas UK has been suspended as a member of the Association of the British Pharmaceutical Industry.
Astellas UK has been suspended as a member of the Association of the British Pharmaceutical Industry.

A pharmaceutical company has been suspended by a UK trade group over "deception".

Astellas UK has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) for a year over "serious breaches" of the trade group's code of practice.

The pharmaceutical company paid a number of UK health workers to be on an "advisory board" in February 2014, but the meeting was actually a "promotional meeting", officials found.

It was alleged that Astellas presented the benefits of one of its medicines enzalutamide (also known as Xtandi) for a purpose which it had not yet been approved.

One of the delegates reported the company, saying that "Astellas was not truthful as to why delegates had been invited to the meeting and the company promoted something it should not have done".

And it later emerged that Astellas Europe had "knowingly provided incorrect information" to the Prescription Medicines Code of Practice Authority (PMCPA) which had investigated the claims, the ABPI said.

A whistleblower contacted the PMCPA because they were concerned over the "truthfulness of Astellas's response" to the initial investigation.

The drugs company had told the the PMCPA, which independently regulates the ABPI's code of practice, that it had selected invitees to the meeting based on their "clinical expertise".

But a leaked email showed people were invited because they were "mid-to-top level opinion leaders with the potential to be local product champion" who were "data naive", meaning they had not been on an Astellas Europe advisory board in the past.

The PMCPA panel ruled that information about the eligibility criteria should have been presented to the initial investigation.

"Astellas Europe had therefore provided not only an incomplete response to that complaint but also a misleading one," the panel said.

The PMCPA reported its findings to the ABPI, saying it was "extremely concerned about the multiple organisational and cultural failings, which included issues of deception".

The ABPI subsequently decided to suspend the membership of Astellas UK for 12 months.

Membership suspension is extremely uncommon, with the last suspension taking place in 2008.

John Kearney, ABPI president, said: "Breaches of the code are viewed seriously and this is reflected by the suspension. Our industry works under strict regulations and any company that fails to meet these standards will be held accountable."

A spokeswoman for Astellas UK said: "Astellas takes its responsibilities to uphold the letter and spirit of the ABPI code of practice very seriously and accepts fully the decision of the ABPI board of management.

"Astellas believes that a strong compliance governance and framework is essential and a comprehensive plan has been in place over recent months to create and maintain a culture where compliance, ethics and integrity are embedded and reinforced at all levels within the organisation.

"Astellas is committed to achieving the required standards of compliance necessary for APL to have its membership to the ABPI reinstated."

In January, the National Institute for Health and Care Excellence recommended that enzalutamide could be used for routine NHS use as an option for treating people with metastatic hormone-relapsed prostate cancer who have no or mild symptoms after androgen deprivation treatment has stopped working, and before chemotherapy is needed.

The health body said that the drug is a well-tolerated treatment that delays chemotherapy and improves survival.

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