Leo Pharma, AstraZeneca and Daiichi Sankyo have been named in advertisements for bringing discredit upon, and reducing confidence in, the pharmaceutical industry.

LEO Pharma – Case AUTH/3503/4/21

For the unbalanced and misleading presentation of information and the failure to provide up-to-date safety information in relation to its website promoting Kyntheum (brodalumab), Leo was ruled in breach of the following clauses of the 2019 Code:

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

Clause 3.2     - Promotion inconsistent with the SPC

Clause 4.10   - Failing to show an inverted black equilateral triangle to denote that additional monitoring is required in relation to adverse reactions

Clause 7.2      - Making misleading claims

Clause 7.3      - Making misleading comparisons

Clause 7.4      - Making unsubstantiated claims

Clause 7.9     - Making a claim that did not reflect the available evidence regarding possible adverse reactions

Clause 7.10    - Not encouraging the rational use of the medicine

Clause 9.1      - Failing to maintain high standards

LEO Pharma – Case AUTH/3548/7/21

For the improper conduct by a senior Leo employee in actively seeking confidential discount price information about a competitor product from NHS staff, for the purposes of Leo’s own commercial interests, the company was ruled in breach of the following clauses of the 2016 Code:

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

Clause 9.1     - Failing to maintain high standards

AstraZeneca – Case AUTH/3585/11/21

For the misleading omission of the upper limit for the dosing of Symbicort (budesonide, formoterol fumarate) and the strong recommendation in the SPC for patients using more than 16 actuations daily to seek medical advice on the AstraZeneca medicines website; and for failing to include the non-proprietary name for three different medicines and Symbicort prescribing information or a statement as to where it could be found on the Trixeo (formoterol/budesonide/glycopyrronium) website, Astra Zeneca was ruled in breach of the following clauses of the 2021 Code:

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

Clause 5.1      - Failing to maintain high standards

Clause 6.1      - Providing insufficiently complete information such that it was misleading

Clause 6.2      - Proving misleading information which was not capable of substantiation

Clause 12.1    - Failing to include prescribing information

Clause 12.3    - Failing to include the non-proprietary name immediately adjacent to the most prominent display of a brand name

Clause 12.4    - Failing to include prescribing information in digital material or by way of a clear, prominent, direct single click

Clause 12.6    - Failing to include a clear, prominent statement as to where prescribing information could be found

Daiichi Sankyo – Case AUTH/3611/2/22

For failing to make immediately apparent to health professionals in promotional material which referred to the therapeutic use of Nilemdo (bempedoic acid) or Nustendi (bempedoic acid and ezetimibe) in combination with a statin that there was a contraindication regarding concomitant use with simvastatin >40mg daily, Daiichi Sankyo was ruled in breach of the following Clauses of the 2021 Code:

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

Clause 5.1        - Failing to maintain high standards

Clause 6.1        - Misleading impression provided

Clause 6.2        - Misleading impression incapable of substantiation

Daiichi Sankyo – Case AUTH/3612/2/22

For failing to make the contraindication with simvastatin >40mg immediately apparent when presenting Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) indications which referred to their therapeutic use in combination with a statin; and for failing to display prescribing information for adequate time for each medicine during a live symposium, Daiichi Sankyo was ruled in breach of the following Clauses of the 2021 Code:

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

Clause 5.1      - Failing to maintain high standards

Clause 12.5    - Failing to display prescribing information for sufficient duration so that it is easily readable

AstraZeneca – Case AUTH/3618/3/22

For misleading dosing claims on the Forxiga (dapagliflozin) promotional website, which had qualifying and important safety information for patients with severe hepatic impairment in a footnote that could have easily been missed by a health professional, AstraZeneca was ruled in breach of the following clauses of the 2021 Code:

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

Clause 5.1   - Failing to maintain high standards

Clause 6.1   - Providing misleading information

Clause 6.2   - Providing misleading information which was not capable of substantiation

Clause 11.2 - Promotion inconsistent with the summary of product characteristics

Clause 14.4 - Not encouraging the rational use of a medicine

Daiichi Sankyo– Case AUTH/3627/4/22

For the omission of safety information in relation to symptoms, which might not be readily recognised by the patient as signs of excessive bleeding, in two Lixiana (edoxaban) patient booklets, Daiichi Sankyo was ruled in breach of the following clauses of the 2021 Code:

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

Clause 5.1   - Failing to maintain high standards

Clause 6.1   - Providing misleading information

Clause 6.2   - Misleading impression incapable of substantiation

The case reports are available at www.pmcpa.org.uk. 

For more information contact Alex Fell  afell@pmcpa.org.uk 0207 7478878