Advert - Genzyme

For making a presentation about Fabrazyme (agalsidase beta), to an expert advisory group, that was, inter alia, misleading, inconsistent with the Fabrazyme SPC and disparaging of a competitor product, Genzyme was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.

Clause 3.2 - Making claims inconsistent with the SPC.

Clause 7.2 - Making misleading claims.

Clause 7.3 - Making misleading comparisons.

Clause 7.4 - Making unsubstantiated claims.

Clause 7.6 - Referring to published studies without giving clear references.

Clause 7.8 - Providing misleading graphs.

Clause 7.10 - Not encouraging the rational use of a medicine.

Clause 8.1 - Disparaging a competitor product.

Clause 9.1 - Failing to maintain high standards.

Clause 14.1 - Failing to certify material in its final form.

The Code of Practice Appeal Board was so concerned about the content of the presentation, its potential effects and impression given, including the disregard for patient safety, that it decided to require Genzyme to issue a corrective statement to all of those who had been at the meeting or had received a pre-meeting copy of the material.

The full case report, which includes the wording of the corrective statement, was published in the PMCPA May Code of Practice Review and is also available at www.pmcpa.org.uk.

Advert - May 2016