FDA issues draft guidance for drug and device promotions

The Food and Drug Administration (FDA) posted a draft guidance to its Web site on May 26 for how the industry should provide risk information when promoting drugs and devices, partly because industry asked the agency to provide guidelines.

The Food and Drug Administration (FDA) posted a draft guidance to its Web site on May 26 for how the industry should provide risk information when promoting drugs and devices, partly because industry asked the agency to provide guidelines.

While the FDA included Web sites as part of the "promotional"  materials and communications it was referring to, the guidance did not provide separate advice for social media efforts. Also on the FDA's Web site is a link explaining a pending redesign of the agency's site.

Here are some key points from the 27-page document:

- If a company fails to disclose risk information about a product, it can be considered misleading.

- When the FDA evaluates risk information, it looks at specific statements as well as "net impression."

- The FDA assesses messages based on the audience, ranging from healthcare professionals to consumers.

- General considerations include consistent use of language appropriate for target audience, use of signals, framing risk information, and hierarchy of risk information.

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