Rules

Broadcast ads must include the major statement in audio (or audio/visual)

Broadcast ads need a brief summary or adequate provision for labeling access

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

Television DTC ads must present major statement via concurrent audio and text

Television ads: on-screen major statement text must be verbatim key terms or full transcript

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

Reminder ads are limited to specified content only

Reminder ads are not permitted for drugs with a boxed warning

Each specific side effect and contraindication in labeling must be disclosed

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

An ad fails the true-statement test if false or misleading on safety/effectiveness

General group terms may not replace required specific side-effect disclosure

Disclose relevant risk information beyond the narrow scope of the request when material

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

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