Rules

No unsubstantiated drug-to-drug safety/effectiveness comparison

No superiority suggestion via 'does not contain'/potency claims absent adequate support

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

Rx drug ad: effectiveness claims must be balanced by comparable risk information (502(n))

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

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

Effectiveness claims in Rx drug ads must state specific approved indications

Ads for post-1962-NDA/1969-NADA/§572-index drugs may not suggest unapproved uses

Literature may not suggest unapproved conditions of use (Rx drugs)

Fixed-combination Rx ads limit indication to concomitant-therapy patients

Update promotional labeling and advertising promptly after a labeling change

Untrue information in one part of an ad cannot be cured by truth elsewhere

Ad must not omit facts material to its representations or to use consequences

No presenting since-invalidated favorable information as current

No literature/quotations more favorable than the evidence supports

No selective presentation of information to suggest greater safety than demonstrated

No overstating the generalizability of a single study's experience

Disclose when effectiveness claims may reflect concomitant therapy

Disclose placebo-effect info when citing studies for human drug effectiveness

No favorable authority quote without disclosing later or concurrent unfavorable data

No quoting or paraphrasing out of context to mislead

Studies on normal subjects must disclose that fact unless drug is for normal individuals

No Erroneous Use of "No Significant Difference" to Claim Equivalence

No misleading headlines, subheadlines, or graphics in prescription drug ads

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

Source publications that distort studies or include fraudulent data should not be disseminated

Do not share reprints that misrepresent or overstate their findings

Do not share CPGs that misrepresent or overstate their underlying findings

Do not share reference texts or digital resource content that misrepresents or overstates findings

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

Do not include safety/effectiveness representations inconsistent with the source publication

Do not present source publication information out of context

Do not use statistics/techniques to suggest significance beyond what the data supports

Do not use presentational elements to obscure or distort scientific content

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

A risk-information presentation should not open with unrelated content

Ingredient info block must be unbroken when 502(n) data is shown

Ingredient quantity in Rx drug ad must match product label

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

Relationship between proprietary and established name must be made clear

Quantitative ingredient info prominence must reasonably relate to proprietary name prominence

Listing of established names required with prominent display of shared combination name

Combination-ingredient ads: dosage form name and adjacent 502(n) quantities

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

Established name must be at least half size when proprietary name is enlarged in running text

Established name outside running text must be at least half the proprietary name's size

Established name prominence must be commensurate with proprietary name prominence

Established name required once in running text when proprietary name is not featured

Established name required once per detailed-information column

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

Combination products: active ingredients should get commensurate emphasis and contrast

Do Not Claim Investigational Drug Is Safe or Effective in Promotional Context

Do Not Otherwise Promote an Investigational Drug

No Commercial Distribution or Test Marketing of an Investigational Drug

No Test Marketing of an Investigational Drug

Reminder ads are limited to specified content only

Reminder ads are not permitted for drugs with a boxed warning

Each specific side effect and contraindication in labeling must be disclosed

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

An ad fails the true-statement test if false or misleading on safety/effectiveness

General group terms may not replace required specific side-effect disclosure

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

Use a dedicated, separate exhibit-hall space for SIUU communications

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 one that is revised as new evidence warrants

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

Ads with unpublicized fatality/serious-damage information require prior FDA approval once FDA so notifies

Submit Promotional Labeling Specimens at Initial Dissemination

Submit Prescription Drug Ad Specimens at Initial Publication

Submit Sample-Carrying Mailers Complete, Minus the Physical Sample

Attach Completed Form FDA-2253 to Ad/Labeling Submissions

Include Current Professional Labeling With Ad/Labeling Submissions

Submit promo materials for FDA review if disseminated within 120 days of approval

After 120 days post-approval, submit promo materials 30 days before use

Submit pre-approval-window promotional materials during preapproval review

Submit post-approval promotional materials at least 30 days before use

Submit advertisements and promotional labeling to FDA per 314.81(b)(3)(i)

No unsubstantiated superiority claims (better, more effective, safer, broader use)

No implying clinical significance from nonclinical/animal/in-vitro data alone

Cited literature/references must actually support the claim made

No using data from off-label dosages to support favorable claims

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

Continuing to share a retracted source publication is inconsistent with FDA's recommendation

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