Rules

Accurately represent study results relied upon

Disclose material study design/methodology factors

Disclose material limitations of study design, methodology, and results

Firm representatives should disclose their firm affiliation in public responses

Describe all material aspects of study design, methodology, and results for study-focused source publications

Present required disclosures clearly and prominently

Match audio and text disclosures for audio-visual SIUU communications

Firm-generated presentation should identify firm-generated portions

Repeated effectiveness claims in the risk section may dilute required side-effect emphasis

Include related FDA-required labeling data for context when presenting related new information

Include representative publications reaching contrary conclusions when a source's conclusions are disputed

Treat risk information comparably to benefit information throughout

Present risk information in the same parts of the piece as benefits

Make risk information comparably noticeable as benefit information

Make risk information comparably readable as benefit information

Statistical significance should not be used to imply unproven clinical significance

Average results should disclose the range of variation

Retrospective statistical mining to find unsupported findings may mislead

Don't use retrospective stats to imply rigor for unsuited study designs

Tables and graphs must not distort study relationships or trends

No falsely presenting reports/opinions as authentic or authoritative

Communications should not overstate study findings

Do not imply statistical rigor (e.g., via p-values) that the analysis lacks

Disclosing limitations does not cure a claim based on an inadequate study

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

Keep unsolicited-request response material scientific in tone, not promotional

Do not bundle the off-label response with promotional material

Public responses should not be promotional in nature or tone

Do not imply the source data represents broader experience than it does

A deceptive net impression can be misleading even when individual claims are not

Use risk language comprehensible to the same audience as benefit language

Use headlines/signals for risk information whenever benefit information is signaled

Match specificity of risk statements to benefit statements

Risk wording should not minimize the severity of a risk event

Risk ordering should not falsely suggest a risk applies only to certain populations or conditions

Material study limitations should be disclosed

A risk-information presentation should not open with unrelated content

No fanciful name implying unique effectiveness of a common substance

Inert/inactive ingredients may not be featured to overstate their value

No proprietary name confusable with another drug's name

Established name must have prominence commensurate with the proprietary name

Quantitative ingredient info prominence must reasonably relate to proprietary name prominence

Other dosage forms need quantitative info equal in prominence to name listing

Established name should sit directly right of or below proprietary name

Avoid intervening matter that de-emphasizes or obscures the established name

Digital: established name once per web page where proprietary name most prominent suffices

Combination products: avoid intervening matter between proprietary name and active-ingredient information

Combination products: active ingredients should get commensurate emphasis and contrast

Grouped side-effect terms allowed only if previously approved for that use

Disclose relevant risk information beyond the narrow scope of the request when material

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 serious, life-threatening, or fatal risks relevant to the unapproved use

Disclose an applicable REMS and its goals

Risk information should not be presented in only one location of the piece

Promotional pieces should reveal risks material to the specific benefit claims made

Send non-public unsolicited-request response only to the requestor, privately

Have medical/scientific personnel independent of sales and marketing generate the response

Exclude sales and marketing personnel from input on off-label response content

Respond publicly to an off-label request only when it names the firm's own product

Public response should convey the question involves an unapproved/uncleared use

Public response should include specific medical/scientific contact information

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

Keep SIUU communications separate from promotional communications about approved uses

Host SIUU communications on a separate web page from approved-use promotion

Do not link directly from approved-use promotional pages to SIUU pages

Keep SIUU email messages separate from approved-use promotional emails

Do not host SIUU communications on platforms too limited to carry the required disclosures

Share reprints unaltered and unabridged

Reprint's journal should be managed by an independent organization

Reprinted article should be peer-reviewed by subject-matter experts

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

Excerpted clinical reference resource sections must include all information needed to interpret them

Excerpted clinical reference resource sections must be unaltered and extracted directly

Shared CPG must be based on a rigorous, transparent evidence review

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 should come from an independent scientific/medical publisher

Shared reference text/digital resource must follow accepted content-creation and peer-review standards

Shared reference text/digital resource should be authored by demonstrated subject-matter experts

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

Firm-generated presentation should be limited to scientific information from its source publication(s)

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

Do not use calls to value that pre-judge patient benefit

Do not use persuasive marketing techniques unrelated to scientific content

Reprint's journal editorial board should have demonstrated expertise

Reprint's journal should have a public conflict-of-interest disclosure policy

Public response should direct individuals to contact medical affairs for more information

Favorable claims from an inadequately designed study may be misleading

Statistical analyses inconsistent with established statistical principles may be misleading

Mechanism-of-action claims not generally established may be misleading without disclosure

Data relied on must be scientifically appropriate and statistically sound

Source publications must describe scientifically sound studies

Take existing scientific knowledge into account before and during dissemination

Conclusions in a source publication should align with the study's prespecified hypothesis or research question

Conclusions in a source publication should be supported by the study's results