Rules

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

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

Disclose that the unapproved use is unapproved and unestablished

Disclose labeling limitations, restrictions, cautions, warnings, or precautions about the unapproved use

Disclose contraindications from the FDA-required labeling

Disclose serious, life-threatening, or fatal risks relevant to the unapproved use

Disclose an applicable REMS and its goals

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