Rules

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

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

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

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

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

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

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

Established name must have prominence commensurate with the proprietary 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

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

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

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

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

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

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

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

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

Risk information should not appear only on a brief summary page

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