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

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

Disclose unfavorable or inconsistent findings, not just favorable results

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

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

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

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

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

Relationship between proprietary and established name must be made clear

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

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

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

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

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

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

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

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

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

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