Rules

Firm representatives should disclose their firm affiliation in public responses

Provide a copy of or mechanism to obtain current FDA-required labeling

Match audio and text disclosures for audio-visual SIUU communications

Firm-generated presentation itself should include Q2 disclosures

Attribute safety/effectiveness conclusions to the source publication

Firm-generated presentation should identify firm-generated portions

Firm-generated presentation should follow safety claims with contributor disclosure

Multi-page Rx ads may lack fair balance if risk info isn't facing/full page

Disclose the FDA-approved use(s) and labeling limitations

Response should include complete reprints and literature, not just firm summaries

Established name should sit directly right of or below proprietary name

Accompany unsolicited-request response with FDA-required labeling, if any

Public response should include a mechanism to access current FDA-required labeling, if any

Disclose that the unapproved use is unapproved and unestablished

Disclose labeling limitations, restrictions, cautions, warnings, or precautions about the unapproved use

Disclose contraindications from the FDA-required labeling

Disclose an applicable REMS and its goals

Public response should include specific medical/scientific contact information

Detailed off-label response should not be posted publicly in the same forum

Share reprints unaltered and unabridged

Reprinted article or its journal must be generally available through independent channels

Excerpted clinical reference resource sections must be unaltered and extracted directly

Shared CPG must rate the strength/quality of evidence for its recommendations

Shared CPG must be generally available through independent distribution channels

Shared reference text/digital resource must be generally available through independent channels

Firm-generated presentation must be provided together with the source publication