Rules

Accurately represent study results relied upon

Disclose material study design/methodology factors

Disclose material limitations of study design, methodology, and results

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

Include related FDA-required labeling data for context when presenting related new information

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

Make risk information comparably noticeable as benefit information

Make risk information comparably readable as benefit information

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

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

Material study limitations should be disclosed

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

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

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

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

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

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