Rules

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

Facing pages must be clearly marked as one continuous advertisement

Ads targeting a selected patient class may lack fair balance if class-specific risks/dosage are not adequately emphasized

Ad may be misleading if a page/spread lacks risk info or prominent locator reference

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

FDA may object to substantially smaller font for risk information

Do not give benefit information greater contrast than risk information

Make risk information comparably readable as benefit information

FDA may object to risk information in a difficult-to-read font size

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

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

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

Vocalize, visualize, or place concurrent SUPERs for required claim qualifiers

Make SUPERs reasonably visible under typical viewing conditions

SUPERs should remain on screen long enough to be read and understood

Distracting graphics during risk presentations should be avoided

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

Print: established name once per page or spread when running text spans multiple pages

Print: multi-column use of proprietary name allows established name once per page or spread

Radio/telephone ads: established name conjoined with most prominent presentation suffices

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

DTC TV/radio major statement must be clear, conspicuous, and neutral

Major statement must use consumer-friendly, understandable language

Major statement audio must be at least as understandable as rest of the ad

On-screen major statement text must remain readable for a sufficient duration

In TV-format DTC ads, major statement text must be easily readable

No audio/visual elements may interfere with comprehension of major statement

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

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

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

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

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