FDA Seeks Feedback On New Regulations for Disclosing Prescription Drug Risks

The Food and Drug Administration is rewriting the regulations governing how consumers are informed about prescription drug risks. The agency seeks public feedback on the proposed rule by June 28, 2010, at http://www.regulations.gov.

Published March 29, 2010, the proposed rule would require that direct-to-consumer prescription drug advertisements on television or radio convey information about major side effects and contraindications in "a clear, conspicuous, and neutral manner."

These standards would be assessed by whether:

1, The information is presented in language that is readily understandable by consumers;

2. The audio information is understandable in terms of the volume, articulation and pacing used;

3. The textual information is appropriately placed, and presented on a contrasting background, for sufficient time, and in a size and font style that can be read easily;

4. There are no distracting representations, such as statements, text, images or sound, that detract from the communication of the risk information.

Contributing Author

Cristin Schmitz

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