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New FDA guidance for advertising

Clarifies circumstances when drug names need to be mentioned
FDA headquarters White Oak

The US Food and Drug Administration (FDA) has published draft guidance addressing the use of prescription drug names in advertising and promotional labelling

'Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling' will, when finalised, replace the guidance of the same title issued on January 25, 2012.

The draft guidance (PDF) clarifies the requirements for product name placement, size, prominence, and frequency in promotional labelling and advertising for prescription drugs (both human and animal), and underlines the circumstances under which the FDA will exercise its enforcement discretion.

Updates on previous guidance include clarification on the use of a drug's proprietary name in the running text of an advertisement and in what circumstances the proprietary and brand name of a drug need to be seen together.

The new draft guidance also removes the recommendation that the brand name of a drug be included in the audio portion of an audio-visual promotion, and clarifies issues relating to the established name's presentation on web pages or electronic screens

According to the FDA, some 400 firms are responsible for approximately 82,100 advertisements and promotional pieces a year.

It will take firms approximately three hours to compile and draft the information needed to fulfil the product name placement, size, and prominence requirement in advertising and promotional labelling, estimates the organisation.

Comments on this draft guidance should be submitted to the FDA before January 21, 2014.

Despite the number of guidelines published on this topic, the last 15 years have seen the FDA send fewer than 20 warning and untitled letters for human drug and biologic products where the presentation of a product's established name was considered a violation, according to legal firm Hunton & Williams.

Article by
Tara Craig

26th November 2013

From: Marketing



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