Promotional Review: Principles and Practice
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CURRENT OPINION
Promotional Review: Principles and Practice Christopher Allen1
Published online: 14 June 2016 Springer International Publishing Switzerland 2016
Abstract Reviewing promotional materials for pharmaceutical products is important to help ensure their high quality and allow recipients to be well-informed about benefits and risks. This article provides an overview of control mechanisms that can influence the overall quality of the product combined with practical advice, based on personal US and international experience. US case reports are used to illustrate examples of promotional violations, and the consequences of government enforcement.
Key Points Reviewing promotional material before release helps ensure company products are presented in a fair and balanced way, and that material complies with local laws, voluntary industry codes, and business practice. Application of key principles can help to ensure high-quality internal reviews. Traditional review is evolving to address new technologies and communication channels.
& Christopher Allen [email protected] 1
Merck & Co., Inc., 600 Corporate Drive, Lebanon, NJ, USA
1 Introduction While we have come a long way from the deceptive fairground promotional practices involved in dispensing snake oil [1], what companies say about their products should be legal, decent, honest and truthful, and these principles still hold true today. However, why should there even be a need for an internal company committee or process that reviews and approves company printed and electronic promotional materials?
2 Why Do We Need Promotional Review? The purpose of internal company promotional review is to ensure the release of high-quality, well-documented promotional, educational, and informational material that presents the company’s products in a fair, balanced, and ethical manner that helps to ensure patient welfare when the products are used. The quality of the material is used by some external observers as a surrogate for the overall quality of the company (a crude metric being the number of documented local code or government violations). Integrity in such materials reinforces trust with customers and reflects the quality and value of the products. It is also important to bear in mind that the managing director of the operation is ultimately accountable for the business, and the good quality of materials allows the operation to largely function without concerns over personal liability or company time used to deal with inter-company complaints. However, other individuals may be liable under legislation, and in Europe the physician or pharmacist who is the nominated signatory also carries a personal professional liability.
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Company controls described in this article form only one of the control mechanisms that can influence the overall quality of the product. Others include [2]: •
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Voluntary industry associations’ codes of conduct (e.g., International Federation of Pharmaceutical Manufacturers and Associations [IFPMA]) Voluntary nation
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