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FDA proposes guidelines for multimedia ads

The US FDA has issued draft guidance to the pharmaceutical industry outlining how risk information should be presented when advertising prescription drugs and medical devices

The US FDA has issued draft guidance to the pharmaceutical industry outlining how risk information should be presented when advertising prescription drugs and medical devices.

The non-mandatory guidance comes following complaints that the industry had mislead the public about potential risks through the omission of such information. The 27-page draft document uses examples to illustrate the criteria used by the regulator to evaluate the disclosure of risk information within adverts and promotional material and its compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

When evaluating a promotional piece, the FDA looks at the message as a whole (net impression) to ensure it provides a balanced communication, not just whether or not a specific element (such as risk information) is included, the document states. For example, a bold headline about the benefits of the drug, with a small, inconspicuous footer about the risks can lead to patients getting the overall impression that the drug is safer than it has been proven to be without the manufacturer actually printing anything that is factually inaccurate.

Broadcast adverts should allocate equal proportions of time to both benefits and risks according to the FDA. The guidance also advises that the tone of any given piece of advertising should be consistent and relevant to its audience. While the regulator accepts that information provided to members of the medical profession, purely for their own use, can contain technical terminology, it stressed information for the public should be written clearly, and presented in a consumer-friendly format.

In April, PMLiVE reported that the FDA had issued warning letters to 14 pharma companies over their use of sponsored advertising on internet search engines such as Google and Yahoo. The letters were issued because the FDA claimed that the sponsored links did not contain sufficient risk information about the individual drugs.

28th May 2009

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