Shire Pharmaceuticals Ltd and Roche Products Limited have been sued for advertising violations under the ABPI Code of Practice bringing discredit, and reducing trust in the pharmaceutical industry.
Shire - Case AUTH/2528/8/12
For a press release for VPRIV (velaglucerase alfa) that was misleading, inaccurate, derogatory, (…), Shire was sued in violation of the following provisions of the Code:
Clause 1.8 – Failure to comply with the Code.
Clause 2 - Bring discredit, and reduce trust in the pharmaceutical industry.
Clause 4.1 – lack of prescribing information in promotional materials.
Clause 7.2 - Making misleading claims.
Clause 7.3 - Making a misleading comparison.
Clause 8.1 - Making derogatory statements.
Clause 14.1 - Failure to Certify Promotional Materials Prior to Release.
Clause 14.5 - Failure to Certify Promotional Materials Prior to Release.
Clause 22.1 – Promotion of single drug prescription to the public.
Clause 22.2 – Encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine.
Voluntary admission by Roche – Case AUTH/2582/2/13
Roche has made a voluntary acquiescence in connection with unlicensed distribution by mailing for an unlicensed drug. Roche was called up in violation of the following provisions of the Code:
Clause 2 – Bringing discredit, and reducing trust in the pharmaceutical industry.
Clause 3.1 – Promotion of a medicine before the granting of a marketing authorisation.
Clause 9.1 - Failing to maintain high standards.
Clause 14.1 - Failure to certify promotional materials prior to release.
Full case reports were published in the May PMCPA Code of Practice Review and are also available at www.pmcpa.org.uk
Under the provisions of the Constitution and Procedure, the PMCPA Prescribing Code sets out brief details of all instances where companies are sued in violation of Clause 2 of the code, are required to issue a corrective statement, or are subject of a public appeal.
Translation by Riccardo Bevilacqua
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