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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

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Old 28th December 2011, 06:13 AM
Pharma Newshound Pharma Newshound is offline
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Default FDA Issues Guidance on Responding to Unsolicited Requests for Off-Label Information

Source: FDA

FDA has issued "Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." This guidance includes guidelines for responding to unsolicited requests for off-label information encountered through "emerging electronic media."

See the guidance document (pdf) attached.

[For a more detailed analysis, read this Pharma Marketing Blog post.]

NOTE: FDA says: "Firms may choose to respond to unsolicited requests for information about off-label uses of their approved or cleared products in a manner other than that recommended in this draft guidance. Such activity would not constitute a per se violation of the law, but could potentially be introduced as evidence of a new intended use."

Some excerpts regarding responding on public (eg, Internet) forums:

"This draft guidance provides FDAís recommendations to firms wishing to respond to unsolicited requests for off-label information, including both requests made directly and privately to firms and requests made in public forums, including through emerging electronic media."

"FDA recognizes 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 firmís 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 firmís products."

Solicited Requests
"FDA considers requests for off-label information that are prompted in any way by a manufacturer or its representatives to be solicited. Such solicited requests may be considered evidence of a firmís intent that a drug or medical device be used for a use other than that specifically approved or cleared by FDA."

"Statements that promote a drug or medical device for uses other than those approved or cleared by FDA may be used as evidence of a new intended use. Introducing a product into commerce for such a new intended use without FDA approval or clearance would, under these requirements, generally violate the law."

Youtube example of "solicited request":
"A firm asks or otherwise encourages users to post videos about their own uses of its product on third-party video-sharing sites (e.g., YouTube), which may result in video postings about an off-label use of its product. If the firmís initial request for posting of videos results in any questions about off-label uses, or if any off-label video posting made in response to the firmís 1encouragement of video postings results in questions about the productís off-label use, these questions would be considered solicited requests."

Blogger example of "solicited request":
"If a firm sends out packets of information to known bloggers or online consumer reviewers and encourages them to write about an off-label use of its product on third-party sites and this then provokes a discussion about that off-label use, any requests inquiring about the productís off-label use as a result of these blogs, whether posted as comments to the third-party site or directed to the firm, would be considered solicited requests."

Twitter example of "solicited request":
"If a firm announces results of a study via a microblogging service (e.g., Twitter) and suggests that an off-label use of its product is safe and effective, any comments and requests received as a result of the original message about the off-label use would be considered solicited requests."
Attached Files
File Type: pdf 9565 Unsolicited Requests Draft Guidance_cleared.pdf (257.3 KB, 321 views)
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Last edited by Pharma Newshound : 28th December 2011 at 08:23 AM.
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