(1) The advertisement should be disease-specific and enhance consumer education.
(2) The advertisement should convey a clear, accurate and responsible health education message (i.e., information on the prevention or treatment of a disease, disorder or condition).
(3) In all cases the advertisement should refer patients to their physicians for more information.
(4) The advertisement should not encourage self-diagnosis and self-treatment, but should identify the consumer population at risk.
(5) Discussion of the use of the drug product for the disease, disorder, or condition should exhibit fair balance.
(6) Warnings, precautions, and potential adverse reactions associated with the drug product should be clearly explained so as to facilitate communication between physician and patient.
(7) No comparative claims can be made for the product. In the interest of fair balance, alternative non-drug management options for the disease, disorder or condition can be included.
(8) The brief summary information should be presented in a language that can be understood by the consumer.
(9) The advertisement must comply with applicable FDA rules, regulations, policies and guidelines as provided by their Division of Drug Marketing, Advertising and Communications.
(10) The advertisement should be part of a manufacturer's education program that would include collateral materials to education both physician and consumer.
(11) The manufacturer should not run concurrent incentive programs for physician prescribing and pharmacist dispensing.
