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Unapproved Indications Guidance Proves Controversial

 
• By Elizabeth Orr

US FDA has collected more than 100 comments on a pair of draft guidance documents about manufacturer speech relating to unapproved devices or information not listed in device labeling. A document allowing manufacturers to disseminate some information not in the labeling drew fire from both sides, with patient groups worrying the change could pose a risk to the public, while trade groups saying the communication protections were still too narrow.

Trade groups, manufacturers and patients alike weighed in on a pair of US FDA draft guidance documents that were issued in January to address manufacturer communications, with 110 comments collected before the April 19 deadline and posted online this week.

The agency collected 86 comments on a draft guidance on manufacturers’ communications about unapproved uses of medical products, with an...

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