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Off-Label Communication: Industry Opposes Exclusion Of Phase II Data From US FDA’s Guidance

 
• By Brenda Sandburg

Revised draft guidance about scientific information on unapproved uses (SIUU) of medical products is “impermissibly paternalistic and overly restrictive of scientific speech,” MIWG says.

Off label use
The pharma industry criticized guidance on communication of scientific information about a product's unapproved uses. • Source: Shutterstock

The US Food and Drug Administration’s revised draft guidance on scientific communications to health care providers about a medical product's unapproved uses did not dampen industry’s decade-long objections to its regulation of such speech.

The Medical Information Working Group, comprised of nine pharma companies, said the guidance exceeds the statutory and constitutional limits on the agency’s authority and is likely to chill a significant amount

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