, Volume 23, Issue 3, pp 165-175
Date: 23 Aug 2012

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1. US FDA Wants Balance in Risk Information

The US FDA has released a draft guidance for the industry outlining how to present risk information in advertizing and promotional materials.

Recently published industry guidelines encourage drug manufacturers to develop promotional material for their products that achieves a “balanced presentation of both the benefits and the risks” associated with that product. Tellingly, the most common violation of the regulations cited in enforcement letters sent to sponsors is the omission or minimization of risk information. In issuing the draft guidance, the FDA aims to help sponsors effectively communicate risk information in their promotion to both consumers and healthcare professionals.

Accurate ‘Whole Picture’ is Vital

One point highlighted in the guidance is that, when evaluating the risk information in promotional materials, the agency looks not only at the individual risk-related statements but also at the net impression — the message conveyed by a ...