Surveillance

DDMAC monitors prescription drug promotion for compliance with the law. Promotion cannot be false or misleading and must be presented with fair balance. Types of promotion include, but are not limited to, detail aids, sales aids, journal ads, direct-to-consumer ads, product information on the Internet, and radio and TV advertisements.

DDMAC conducts surveillance in a variety of ways:

1. Submissions from drug applicants:

FDA's regulations at 21 CFR 314.81(b)(3)(I) require drug applicants to:

. . . submit specimens of mailing pieces and any other labeling devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. . . . Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product's current professional labeling.

DDMAC reviews these pieces to determine if they meet the requirements of the Act and the regulations.

To obtain Form FDA 2253, write to the following address:

2. Conferences: DDMAC staff attend medical professional conferences where they observe company exhibition booths and collect promotional materials to review.