Anzal’s Summary of Case Study 1
CASE AUTH/3563/9/21 and CASE AUTH/3564/9/21 (COMPLAINANT v BRISTOL-MYERS SQUIBB AND PFIZER)
CASE SUMMARY
- The complaint was related to the promotion of Eliquis (apixaban) on the Eliquis website (Eliquis.co.uk) and alleged breaches of Clauses 6 and 14 of the Code.
- The complaint stated that the website messaging “Choose Eliquis” was a bold statement that should not be there, as it appeared as if the viewer was being told to choose the product over others for patients.
- The complaint also alleged that the website did not include the necessary adverse event reporting wording as per Clause 12.9 of the Code.
- The Alliance, consisting of Bristol-Myers Squibb and Pfizer, developed and reviewed the Eliquis website.
- The website was divided into three sections: for health professionals, for patients, and for members of the public.
- The “Choose Eliquis” banner was located at the top of multiple pages in the health professional section. The banner included six tabs with the Eliquis licensed indications and was static, allowing health professionals to access the licensed indications at all times.
- The Alliance submitted that the information provided on the page was thorough, up-to-date, accurate, fair, balanced, and within the licensed indications of Eliquis, supporting health professionals in making appropriate prescribing decisions.
- The Alliance disagreed with the concern that the “Choose Eliquis” banner gave the impression that the reader was being told to choose Eliquis over other products.
- The Alliance submitted that the disclaimer at the outset and on arrival at the landing page indicated that the website was only intended for healthcare professionals seeking information on Eliquis in the UK.
Panel Ruling:
- The Panel considered a complaint about the promotional website for the medicine “Eliquis” and found that the banner headline “Choose Eliquis” on the website for health professionals might not be inappropriate, as it would be up to the professional judgement of the health professionals to decide which treatment to give to a patient.
- However, the Panel ruled a breach of Clause 12.9 of the 2021 Code as the adverse event reporting statement was not included within the body of the promotional website for health professionals.
- The Panel concluded that the companies did not fail to maintain high standards and ruled no breach of Clause 5.1 of the 2021 Code.
Clauses:
The clauses mentioned in CASE AUTH/3563/9/21 and CASE AUTH/3564/9/21 are:
- Clause 5: High standards must be maintained
- Clause 6: The promotion of a medicinal product must be conducted in a responsible manner and be presented in a manner that is factual, balanced and not misleading
- Clause 12.9: All promotional material must include the prominent statement
- Clause 14: Promotional material must be based on the summary of product
MedicalGoGo Learning points:
· Adherence to regulatory requirements: Ensure that all promotional materials, including websites, comply with the relevant regulatory requirements and codes of practice, such as the one outlined in this complaint (Clause 5.1, 6.1, 12.9, and 14.4 of the Code).
· Appropriate messaging: Be mindful of the messaging used in promotional materials and ensure that it is not misleading or inappropriate. The messaging should be balanced and accurate, and should not convey the impression that one product is being recommended over others.
· Adverse event reporting: Include the necessary adverse event reporting wording in all promotional materials as per the regulatory requirements (Clause 12.9).
· Audience-focused information: Ensure that the information provided on the website is tailored to the needs of the target audience and provides accurate, fair, and balanced information to help healthcare professionals make appropriate prescribing decisions for their patients.
· Verification process: Implement a verification process to ensure that only the intended target audience has access to the health professional section of the website.
· Maintaining high standards: Adhere to high ethical and professional standards in all promotional activities to maintain the reputation of the company and the industry.