US regulators have issued guidelines to drugmakers about the way they should present risk information for the treatments when advertising on television or in journals.

The 27-page “Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion” has been issued by the US Food and Drug Administration. It covers a wide range of areas and includes advice that television advertisements should avoid using “distracting images and music that can reduce viewers' comprehension of potential side effects”.

Advertisements also should use similar type styles and voice-overs when conveying benefits and risks, the agency says. The guidelines note that busy and frequent scene changes plus camera angles "can misleadingly minimise the risks of the product being promoted by detracting from the audience's comprehension”.

The FDA noted that "if risk information is considerably more difficult to hear and process than benefit information because it is presented at a much faster pace, the piece will not convey an accurate impression". In terms of the advice over print, the agency also spoke about consistent use of white space, font style and size.

The guidance is in part a response to criticism of the industry for using various techniques on television and in print which could be seen as downplaying risks while emphasising the benefits of the drug. The agency concludes that it will consider "the net impression conveyed by all the elements of a piece”. For this reason, “manufacturers should focus not just on individual claims or presentations but on the messages conveyed by the promotional piece as a whole".

The FDA guidelines are not mandatory but Ken Johnson, senior vice-president for the Pharmaceutical Research and Manufacturers of America, noted that the industry has already adopted voluntary guidelines that say risks "should be presented in clear, understandable language without distraction". He added that drugmakers "remain committed to producing responsible, balanced promotional materials".