Promotional materials: which references to use, how to reference them?

May 16, 2024 — published by Pyramidale Communication,
medical communications agency

Documents promotionnels : comment les référencer ?

Promotional materials: the keys to anticipating, planning, and successfully submitting your ANSM filings!

Are you a product or assistant product manager in the pharmaceutical industry who wants to learn about the rules and processes for submitting promotional materials?

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Promotional materials: which references to use, how to reference them? the essentials^1,3

Data included in promotional materials must be based exclusively on studies published in peer-reviewed journals and accurately referenced.
Only unpublished studies from the marketing authorization dossier or the Transparency Committee (CT) opinion as well as clinical practice guidelines, are permitted.
References based on PSURs (Periodic Safety Update Reports) data are not accepted. Only PRAC (Pharmacovigilance Risk Assessment Committee) data published on the EMA or ANSM website may be used to support the safety profile of a medicinal product.

What references should be used for promotional materials?^1-3

Data included in promotional materials must promote the proper use of medicines by presenting them in a precise, balanced, fair, objective, sufficiently complete, and understandable manner, enabling recipients to form their own opinion on the therapeutic value of the medicinal product concerned.
Data must be based on an up-to-date assessment of all relevant information and reflect it faithfully. The content of promotional materials must be justifiable, in particular by reference to authorised information and/or scientific evidence. Such justifications must be made available promptly in response to reasonable requests from healthcare professionals.

1. Data source:

Studies published in peer-reviewed journals, conducted under the conditions of use of the medicine as defined by the product’s marketing authorization, as well as other existing reference documents, such as the Transparency Commission’s opinion and clinical practice guidelines.
Unpublished studies that may be used are limited to those included in the product’s marketing authorization dossier and compliant with the MA wording and, where applicable, those used for the preparation of the CT (Commission de la Transparence) opinion and consistent with the CT conclusions.
Important! Studies that have only been “submitted” or “accepted for publication” are not acceptable, nor are “appendices” or any other author contributions that have not been validated by the journal’s peer-review committee. “Abstracts”, “posters”, “special editions”, and “special issues” produced under a contractual relationship between the publishing journal and the relevant pharmaceutical company must be excluded.
PSURs (Periodic Safety Update Reports) are mainly based on adverse events reported through spontaneous reporting and are therefore observational. As they are not published, these data cannot be verified by recipients and may not be cited in promotional materials, except to present medicinal product exposure data (e.g. number of patients treated). Only elements validated by a health authority, such as communications issued by the PRAC and published on the EMA or ANSM websites, may be used to illustrate the safety profile of a medicinal product.

2. Types of studies selected:

In the context of comparative promotion, explanatory studies are more appropriate for supporting efficacy or safety considerations. They must be prospective, controlled, randomised and, where possible (and depending on the context), blinded, with justified sample sizes ensuring sufficient statistical power.
For the assessment of therapeutic benefit and clinical added value, other pragmatic methodologies or other “naturalistic” study conditions are relevant and may be accepted subject to specific justifications.
Data from robust meta-analyses are acceptable.

Warning: Where a publication relates to a study that has not been assessed by health authorities, particularly in the context of the MA, the ANSM may require the study analysis report before authorising its use in promotional materials.

3. Use of quotations:

Quotations from medical and scientific literature may be used but must be reported faithfully, except when adaptation or modification is required to comply with these rules. In this case, the promotional document must clearly state, “Quotation adapted and/or modified,” and cite the sources.

4. Use of illustrations:

When illustrations, including graphs, diagrams, photographs, or tables taken from published studies, are included in promotional materials, the source must be clearly indicated.
Illustrations must be reproduced faithfully unless adaptation or modification is required for compliance, in which case it must be clearly stated that the illustration has been adapted and/or modified.

How should promotional materials be referenced?¹

All data must be supported by complete bibliographic references: Author(s). Title of the article. Abbreviated journal name. Year; volume(issue): start page–end page. For online publications, include the DOI (Digital Object Identifier).
For studies consolidating a result, property, or claim related to the product, regardless of methodology (e.g., clinical, preclinical, or pharmacokinetic studies), the promotional document must specify if the publication is from a study used in marketing authorization evaluation or the transparency file. If necessary, the document must also include the name or number of the study to match the results presented in the Summary of Product Characteristics (SmPC), European Public Assessment Report (EPAR), or CT (Commission de la Transparence) opinion. The study date and number must be specified when the source is an unpublished document (MA or Transparency dossiers).
Tolerance statements must be factual, consistent with the known safety profile, and based on scientific evidence, such as clinical trials and adverse event monitoring included in the product’s marketing authorization. For example, an anticancer drug could not claim “manageable tolerability” if it has caused fatal adverse events or led to permanent treatment discontinuation. Claims such as “excellent tolerance/safety” or “safe/risk-free medicine” are prohibited.
As the safety profile may evolve depending on the real-world use of the medicinal product, it is not possible to describe tolerability as “predictable” or to highlight that no adverse effects are expected for a medicine. Emphasising product tolerability must not induce direct or indirect comparisons with products in the same therapeutic class unless justified by comparative tolerability data.

Coming up in our next article:

The end of Google Analytics: what changes for your websites?

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References:

ANSM, documents de références –source de données
Leem, dispositions déontologiques professionnelles : https://www.leem.org/sites/default/files/DDP%20ApplicablesAu-12%20janv%202016_0.pdf
ANSM, documents de références – présentation des données de sécurité.

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