Rules

Prescription drug ads need true brief summary, with broadcast alternative

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

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

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