New guidance to ensure medicine label claims are genuine

The FDA guidance is titled “Providing Regulatory Submissions in Electronic and Non Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The focus of the document is to provide guidance for pharmaceutical manufacturers, packers and distributors in relation to promotional materials for human

prescription drugs.

By promotional labeling this generally refers to any labeling, other than the FDA-required labeling, that is devised for promotion of the product and can include TV ads, brochures, booklets, websites and any other source, be that paper-based or digital.

The guidance considers appearance, layout, format, and visible impression of promotional materials submitted, and, in tune with the modern age, embraces everything from the style of a promotional booth to the marketing of medicines through the use of video games.

An example of inaccurate marketing is provided by Forbes. This relates to the company Allergan which produced a new eyelash thickening drug Latisse

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