Rules

Firm representatives should disclose their firm affiliation in public responses

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 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

Make risk information comparably noticeable as benefit information

Make risk information comparably readable as benefit information

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

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

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

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

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

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

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

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

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

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