FDA releases finalised guidance on promotional labelling and advertisements for medicines

Draft guidance from 2013 has been finalised by the US Food and Drug Administration (FDA) which clarifies the requirements for product name placement, size, prominence, and frequency in promotional labelling and advertisements for human prescription drugs. To ensure safe and effective use of a medicine, the disclosure of the product name in promotional labelling and advertisements is important for identification.

In addition to a title change and editorial changes for clarification, the guidance has been updated to clarify particular concepts discussed in the revised draft guidance and gives examples illustrating prominence issues.

Further issues that are clarified in the guidance by the FDA concern the direct conjunction of the proprietary and established names, including the frequency of use of the established name on printed pages or spreads, in running text or columns, in the audio proportion of audio-visual promotions and in electronic media.

The recommendations apply to product names in print media promotional labelling and advertisements, broadcast advertisements, electronic and computer-based promotions and audio-visual promotional labelling.

To read the finalised guidance on promotional labelling and advertisements, please click here.