Rules

No unsubstantiated drug-to-drug safety/effectiveness comparison

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

Superiority claims require a study designed to establish superiority

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

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

Disclose authors/contributors with firm financial relationships

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

Describe all material limitations of study design, methodology, and results

State the publication date of referenced source publications

Present required disclosures clearly and prominently

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

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

Prescription-drug ad may lack fair balance if side-effect prominence trails efficacy

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

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

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

Disclose unfavorable or inconsistent findings, not just favorable results

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

Risk information should increase as benefit information increases

Treat risk information comparably to benefit information throughout

Include risk information in the main part of the piece

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

Complete separation of benefit and risk information lacks appropriate prominence

Make risk information comparably noticeable as benefit information

FDA may object to substantially smaller font for risk information

Use similar type styles for risk and benefit 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

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

Dosage safe for one patient class may not be implied safe/effective for another

Update promotional labeling and advertising promptly after a labeling change

Communication must not suggest an indication different from labeling

Communication must not suggest use outside approved patient population

Communication must not conflict with labeled use limitations or handling directions

Communication must not conflict with labeled dosing, regimen, route, or strength

Communication is not consistent with labeling if it increases potential for harm relative to labeling

Communication is not consistent when labeling does not enable safe and effective use as suggested

Disclose the product's FDA-approved indication(s) prominently in the response

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

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

Misleading omissions in prescription drug ads require added qualification within that part/theme

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 misleading pooled statistics in prescription drug advertising

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

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

Claims should not rest on speculation, belief, or a poorly designed or conducted 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

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

Risk information should be preceded by a signal indicating risk information follows

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

Qualifying SUPERs should appear close enough to the claim they qualify

Do not rely on a single line of text for complex qualifying information

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

Risk-related SUPERs should not compete with unrelated SUPERs on screen

Material study limitations should be disclosed

A risk-information presentation should not open with unrelated content

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

Ad ingredient order must match order on product label

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

Established name must accompany proprietary name each time featured in prescription drug ads

Established name must appear with proprietary name in running text

Established name sizing in detailed running-text columns, incl. larger-type proviso

Relationship between proprietary and established name must be made clear

Established-name lettering ≥ half size of featured proprietary name in Rx drug ads

Established name must have prominence commensurate with the proprietary name

Place quantitative ingredient info with prominent proprietary name for unnamed drug mixtures

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

Trademark and controlled-substance symbols do not count as intervening matter

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

Type size is measured by actual letter height, not point 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

Print: established name once per page or spread suffices for featured proprietary name

Print: established name required once in running text when proprietary name only in text

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

Audiovisual/broadcast headline: place established name in conjunction with proprietary name's most prominent display

Established name should be on screen as long as the proprietary name

Bottom-of-screen supers do not require the established name

Audio portion of audiovisual/broadcast material need not include established name

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

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

Digital: established name required once in running text when proprietary name not featured

Combination products: active ingredients should be placed directly right of or below proprietary name

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

Combination products: active ingredients should get commensurate emphasis and contrast

Established name should accompany proprietary name at its most prominent web-page display

Audiovisual supers: established name should accompany prominent proprietary-name display

Established name must accompany proprietary name presentation in radio/telephone ads

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

Prescription drug ads need true brief summary, with broadcast alternative

Broadcast ads must include the major statement in audio (or audio/visual)

Broadcast ads need a brief summary or adequate provision for labeling access

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

Television DTC ads must present major statement via concurrent audio and text

Television ads: on-screen major statement text must be verbatim key terms or full transcript

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

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

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

State prominently that FDA has not approved or cleared the discussed use

Include prominent statement of all important safety information, including any boxed warning

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

FDA recommends stating the most important risk information first, especially in print

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

Risk information should not appear only on a brief summary page

Full Scientific Exchange About an Investigational Drug Is Not Restricted

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

Response to an unsolicited request should be tailored to the specific question asked

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

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

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 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

Source publication(s) for a firm-generated presentation must meet Q1 and Q4 recommendations

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

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)

Qualified personnel should review CFL promotional communications before dissemination

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

Data relied on must be scientifically appropriate and statistically sound

Rely on published peer-reviewed or independent-source data to the greatest extent possible

Use reprints only from journals with a stated conflict-of-interest disclosure policy

Provide a complete reference list for all information disseminated in the response

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

Disclose conflicting conclusions from other scientifically sound studies, with citations

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