New draft guidelines for drug information released

The FDA has recently unveiled the latest version of its draft guidance aimed at pharmaceutical companies using printed materials to disclose information about their medications to the public.

This is a significant revision over the guidance released in the January of 2014, and printing companies may find themselves called upon to help create and produce the recommended style of informational leaflets.

The new rules will be much more streamlined than they were in the past, and will allow a “brief summary” of the side effects to be included in the package insert.

There are also recommendations about the language and layout of the informational material, and a printing company will be able to provide advice about how best to incorporate them into its design.

It is advised that drug manufacturers use language that is easy to understand for people of various literacy levels, and that a conversational tone that avoids the use of technical jargon be used.

Headings and subheadings that make the item easier to read are best, according to guidance, and logos and branding colors should be consistent and included often. Font styles and text sizes that are easy to read are also encouraged. Further, text boxes that contain bullets and other mechanisms designed to draw a reader’s attention are advised, as they will help to ensure that the person reading the information gleans what they need to.

Firms that provide printing services will be able to prepare these items for insertion into prescription drug packaging.