The Prescription Medicines Code of Practice Authority (PMCPA), a self-regulatory body which administers the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry, have opened cases against Leo Pharma, AstraZeneca and Daiichi Sankyo for bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
AstraZeneca
AstraZeneca was ruled in breach on account of 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. This was 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
In a second case, AstraZeneca was in breach of conduct 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. The company 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
Daiichi Sankyo was ruled in breach 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. The company 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
In a second case, Daiichi Sankyo was ruled in breach 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. This breached 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
In a third and final case, Daiichi Sankyo was in breach of conduct with 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. The company 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
Leo Pharma
Leo was ruled in breach of the Code of Practice 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
The company was also in breach as a result of 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. This was 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
