Personal Injury Law

FDA Proposes Stricter Guidelines in Drug Advertisements

By Don Greiwe

Televisions advertisements which drug manufacturers use to target potential customers, also known as Direct-To-Consumer (DTC) ads, are commonplace in the industry. In fact, according to a Public Library of Science report, the industry spent $57.5 billion on advertising in 2004, and only $31.5 billion in research and development in the same year. While not every drug's development costs are dwarfed by advertising costs, these numbers show just how competitive the drug industry has become.

With sophisticated spending comes sophisticated advertisements. Manufacturers have utilized unique methods of promoting their products' benefits without fairly conveying the side effects. A common technique has become creating a busy on-screen image while side effects are being described, distracting the average viewer. Schering-Plough drew criticism from a congressional hearing for its Nasonex ad featuring a bee that flew around during a description of side effects but simply hovered while benefits were explained.

The FDA already has guidelines in place, but they are fairly basic and do not address some of the newer tactics used by drug manufacturers. Representatives of the drug industry have stated they have adopted their own stricter 'standards' for advertising, but certainly this is a situation where FDA needs to revise its standards.

In response to the manipulation of the rules set in place, the FDA has drafted a set of guidelines which go into particularity, even giving examples of do's and don'ts in DTC advertising. The proposed guidelines are found in a draft report titled 'Presenting Risk Information in Prescription Drug and Medical Device Promotion.'

This looks to be a big leap forward in regulating the drug industry's DTC ads, and hopefully will be finalized without major change in the near future.

Full post as published by Tampa Bay Personal Injury Law on June 16, 2009 (boomark / email).