Martindale Pharma, Pierre Fabre, Janssen and Pharmasure have been named in advertisements(1) following breaches of the ABPI Code of Practice for the Pharmaceutical Industry.

Martindale Pharma – Case AUTH/2961/6/17

For advertising Espranor oral lyophilisate (buprenorphine) (substitution therapy for opioid dependence) to the public and for making claims in material aimed at patients and health professionals which were, inter alia, prejudicial to patient safety, Martindale was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 7.2 - Providing misleading information
Clause 7.3 - Making misleading comparisons
Clause 7.4 - Making unsubstantiated claims
Clause 7.9 - Making claims that did not reflect the available evidence regarding possible adverse reactions
Clause 9.1 - Failing to maintain high standards
Clause 26.1 - Advertising a prescription only medicine to the public
Clause 26.2 - Providing unbalanced information and encouraging members of the public to ask for a specific prescription only medicine

Pierre Fabre – Case AUTH/2962/7/17

For briefing representatives about Toviaz (fesoterodine) using an uncertified presentation and failing to provide complete information, Pierre Fabre was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 9.1 - Failing to maintain high standards
Clause 14.1 - Failing to certify promotional material
Clause 15.9 - Producing representatives' briefing material that did not comply with the relevant requirements of the Code

The Code of Practice Appeal Board(2) publicly reprimanded Pierre Fabre for providing inaccurate information to the Panel.

Janssen – Case AUTH/2978/9/17

For promoting a medicine prior to the grant of its authorization Janssen was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 3.1 - Promotion prior to the grant of the marketing authorization
Clause 9.1 - Failing to maintain high standards

Pharmasure – Case AUTH/3008/1/18

For providing a group of health professionals with a hamper of chocolates, Pharmasure was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 9.1 - Failing to maintain high standards
Clause 18.1 - Providing a gift in connection with the promotion of medicines

Pierre Fabre – Case AUTH/3012/1/18

For failing to certify representatives' briefing materials and one presentation aimed at health professionals which promoted an unlicensed medicine, including briefing materials related to Toviaz (fesoterodine) that were misleading, not capable of substantiation, and which advocated a course of action likely to lead to a breach of the Code, Pierre Fabre was ruled in breach of the following clauses of the Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 3.1 - Promoting an unlicensed medicine
Clause 7.2 - Providing misleading information
Clause 7.4 - Making an unsubstantiated claim
Clause 9.1 - Failing to maintain high standards
Clause 14.1 - Failing to certify material
Clause 15.9 - Producing briefing material likely to lead to a breach of the Code