Vifor Pharma, Napp, Otsuka Europe, Otsuka UK , Teva UK, Bayer, Janssen, Merck Serono, Britannia, Novo Nordisk, Rayner and Shionogi Europe named in advertisements for breaches of the ABPI Code

 

Vifor Pharma – Case AUTH/3199/5/19

For failing to comply with undertakings given in two previous cases in relation to the promotion of Ferinject (ferric carboxymaltose), including sending a promotional email without the prior consent of a recipient and the use of misleading claims which favourably differentiated its IV iron from a competitor on the grounds of tolerability, Vifor Pharma was ruled in breach of the following clauses of the Code:

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

Clause 29         - Failing to comply with an undertaking

 

Vifor Pharma – Case AUTH/3224/7/19

For making misleading and inaccurate claims which favourably differentiated Ferinject (ferric carboxymaltose) from a competitor on the grounds of tolerability, Vifor Pharma 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        - Making misleading and inaccurate claims

Clause 7.3        - Making misleading comparisons

Clause 8.1        - Disparaging a competitor product

Clause 9.1        - Failing to maintain high standards

In both cases Vifor Pharma was reported to the Code of Practice Appeal Board⁽²⁾ which was very concerned that the initial responses from Vifor could be described as obstructive, defensive, aggressive, dissembling and untrue.  The Appeal Board noted Vifor’s subsequent responses to the PMCPA and its admission of errors and that it accepted responsibility for the breaches of the Code.  Although Vifor submitted that there had been consequential changes in its senior management and the company was committed to change how it promoted its medicines, the Appeal Board publicly reprimanded Vifor for its failure to provide accurate and truthful information to the Code of Practice Panel and its disingenuous approach to responding to the complaints.  The Appeal Board also required an audit of Vifor’s procedures in relation to the Code. 

 

Napp – Case AUTH/3200/5/19

For the provision of excessive hospitality and entertainment at a five-day promotional meeting for pain specialists, held in New York in the early 2000s, Napp was ruled in breach of the following clauses of the 2001 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

Clause 19.1      - Providing excessive hospitality

 

Otsuka Europe and Otsuka UK – Cases AUTH/3219/6/19 and AUTH/3220/6/19

Otsuka Europe and Otsuka UK voluntarily admitted omissions and errors in the prescribing information for four of its medicines and breaches of undertakings given in relation to previous cases and were ruled in breach of the following clauses of the Code in relation to Samsca (tolvaptan):

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

Clause 4.1        - Failing to have up-to-date prescribing information

Clause 9.1        - Failing to maintain high standards

Clause 29         - Failing to comply with an undertaking

 

Teva – Case AUTH/3226/7/19

For placing an advertisement for DuoResp Spiromax (budesonide/formoterol fumarate) that was misleading and inconsistent with the summary of product characteristics, Teva 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    - Promoting a medicine in a manner which was inconsistent with                         the particulars listed in its summary of product characteristics

Clause 7.2    - Making misleading claims

Clause 9.1    - Failing to maintain high standards

 

Bayer – Case AUTH/3242/9/19

For its global affiliate providing a UK health professional with inappropriate hospitality during the course of an international congress in France, Bayer UK was held responsible under the Code and ruled in breach of the following clauses:

Clause 2         - Bringing discredit upon the pharmaceutical industry

Clause 9.1      - Failing to maintain high standards

Clause 22.1     - Providing inappropriate hospitality

 

Janssen – Case AUTH/3250/10/19

For promoting Tremfya (guselkumab) for an unlicensed indication and failing to comply with its previous undertaking, 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 3.2      - Promoting a medicine for an unlicensed indication

Clause 9.1      - Failing to maintain high standards

Clause 29       - Failing to comply with an undertaking

 

Merck Serono – Case AUTH/3268/10/19

For promoting a homecare delivery service for Mavenclad (cladribine) but not interacting with those with direct responsibility for such services within the NHS, and for not being clear about the company’s relationship with the service provider, Merck Serono 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 9.10      - Failing to clearly indicate its sponsorship of material

Clause 15.2      - Representative failing to maintain a high standard of ethical conduct

Clause 15.4      - Representative failing to observe the arrangements in place  at a particular establishment

 

Britannia – Case AUTH/3297/1/20

Following the attendance of a member of the public at a Britannia symposium where Apo-Go (apomorphine for injection or infusion) was promoted, Britannia 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 26.1      - Promoting a prescription only medicine to the public

 

Novo Nordisk – Case AUTH/3299/1/20

For promoting Saxenda (liraglutide) at a fertility conference without ensuring that materials for health professionals (in addition to references in the prescribing information) and patients made available on a Novo Nordisk exhibition stand made it clear that Saxenda was not to be used in pregnancy, those wishing to become pregnant and those breast feeding, and for failing to be able to show that representatives were trained and their briefing was certified, Novo Nordisk 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        - Failing to reflect the current warnings and potential risks set  out in the summary of product characteristics with respect to the safety of the medicine in pregnancy, those wishing to become pregnant and those breast feeding

Clause 9.1        - Failing to maintain high standards

Clause 15.1      - Failure to be able to show that representatives had been  adequately trained to promote Saxenda within the fertility area

Clause 15.9      - Failure to certify a verbal briefing given to representatives

Clause 26.2      - Providing misleading information for patients

 

Rayner – Case AUTH/3334/4/20

For an apparent lack of care and attention to detail in placing a journal advertisement for Ilube (acetylcysteine eye drops), a prescription only medicine, which was visible to the public when the journal was sent through the post, Rayner 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 9.8        - Advertising on a mailing exposed to the public

Clause 26.1      - Advertising a prescription only medicine to the public

 

Shionogi Europe – Case AUTH/3343/5/20

For promoting Fetcroja (cefiderocol), both before and after it received its marketing authorization, on LinkedIn, Shionogi Europe 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 9.1        - Failing to maintain high standards

Clause 26.1      - Promoting a prescription only medicine to the public

Clause 26.2      - Encouraging members of the public to ask for a specific                                     prescription only medicine

The interim case reports, full case reports and public reprimands are available at www.pmcpa.org.uk.