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During the last week of December, the FDA quietly released “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” The document mentions “electronic media” and includes Twitter, YouTube and blogs in examples. While it isn’t social media guidelines, it does provide insights to be gleaned from reading between the lines. Former FDA official Peter Pitts shares his perspective in Medical Marketing & Media.
What’s interesting is the FDA’s acknowledgment that “it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date information about the firm’s products.”
One key point: the guidance specifies that any public response to unsolicited requests should be from medical or scientific representatives, not sales and marketing. To learn more, read Siren’s blog post.
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