Rules

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

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

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

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

Material study limitations should be disclosed

A risk-information presentation should not open with unrelated content