Astellas reprimanded by U.K. drug regulator

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Astellas UK had made a voluntary admission to the regulator that one of its employees had found patient support material for two of its drugs on the website of one of Astellas's agencies.

The PMCPA Thursday announced that it would run advertisements in the British Medical Journal, Nursing Standard and Pharmaceutical Journal noting the regulatory breach by Astellas U.K., and a separate breach by pharma company Gedeon Richter.

This is a standard disciplinary method used by the body, whose key responsibilites include ensuring that companies may not market, or be seen to market, prescription drugs to the general public.

Astellas U.K. had made a voluntary admission to the regulator that one of its employees had found patient support material for two of its drugs on the website of one of Astellas's agencies.

See also: Industry groups petition the FDA over off-label rule

The ruling says: "Astellas understood that in displaying the material (without Astellas's permission), the agency's intention was to market its abilities, driven by a new creative director who was not trained on the Code. Astellas immediately asked the agency to remove the material, which it did. The web page went live on 15 April 2016 and was taken down on 22 September 2016."

"Astellas discovered that the agency had also used imagery from another Astellas programme, which was closed on 22 May 2016... This identified Astellas medicines within the transplantation area and included product brand names and a claim.

"Astellas considered that the use of the brand names and therapeutic indications on the agency website went beyond any requirement to market creative capabilities and constituted promotion of prescription only medicines to the public, in breach of the Code."

See also: The FDA issues untitled letters to Sanofi and Celgene over distracting ads

Both the PMCPA and Astellas declined to identify the agency involved when contacted by PRWeek.

For this, alongside various other voluntary admissions relating to its patient support programmes, Astellas was ruled to be in breach of nine clauses of the Association of the British Pharmaceutical Industry, which the PMCPA enforces. These include clause two, which covers "bringing discredit upon, and reducing confidence in, the pharmaceutical industry."

GEDEON INACCURACY

In a separate decision from the PMCPA also published yesterday, Gedeon Richter was ruled to have breached the code in three places, including clause two, over inaccuracies in a leaflet for a gynecological drug.

See also: FDA guidance seeks to clarify pharma comms with payers

A patient support leaflet from Gedeon Richter had said women using the drug should not use it alongside oral contraceptives. It should have said "hormonal contraceptives", and in addition to being named in the print ads, has been forced to issue a corrective statement.

The adverts will run on 17 June in the BMJ, 21 June in the Nursing Standard and 24 June in the Pharmaceutical Journal.

This story was first published in PRWeek U.K.

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