AstraZeneca and Genzyme named in advertisements(1) following breaches of the ABPI Code

AstraZeneca Case AUTH/2793/9/15

For producing a leavepiece which provided misleading instructions on how to use the EMIS Web clinical system such that controlled (based on HbA1c levels) type 2 diabetic patients might be inappropriately treated with Forxiga (dapagliflozin), AstraZeneca was ruled in breach of the following clauses of the Code

Clause 3.2 - Making claims inconsistent with the SPC.

Clause 7.2 - Making misleading claims.

Clause 9.1 - Failing to maintain high standards.

The Code of Practice Panel reported the company to the Code of Practice Appeal Board(2) for providing inaccurate information.  The Appeal Board considered that it was fundamental for effective self-regulation for companies to provide accurate information to the Panel and for failing to do so, and for exercising poor governance, it publicly reprimanded AstraZeneca.

The Appeal Board was concerned that use of the leavepiece might lead to the inappropriate prescription of Forxiga, and it required AstraZeneca to issue a corrective statement to recipients of the leavepiece to clarify the position.

​​Genzyme Case AUTH/2721/7/14

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.

​Full case reports, which include the wording of the corrective statements, are published in the May 2016 edition of the PMCPA Code of Practice Review.