PHAR 509: Final Exam

PHAR 509: Final Exam Direct to consumer Advertising (DTC) ads made by pharmaceutical companies directed towards the general public with the aim to promote prescription products directly to patients How do companies communicate? television, magazines, newspapers, radio and internet. these communications often feature a celebrity spokesperson, actors, or computer generated characters generally portraying happy and satisfied patients Types of DTC Advertising help-seeking reminder product claim Help seeking DTC describes the disease state and encourages patients to contact their providers requirements: no product of claims being made so fair balance does not apply. brief summary, major statement, or providing sources or prescribing info not required Reminder DTC states product name but does not mention indication or make any claims requirements: no claims made so fair balance doesn't apply, brief summary, major statement, or providing sources of prescribing info not required. cannot be used for drugs with serious adverse effects Product claim DTC names drug and condition and includes efficacy and safety claims requirements: must fair balance of risks and benefits. for print ads all risks must be included in a brief summary. for broadcast ads most important risks must be included in major statement and must provide sources of prescribing info FDA role in DTC advertising regulation division of drug marketing, advertising, and communications ensures that all prescription drug advertising is truthful, balanced and accurately communicated. "fair balance"- 1997 Evolution of DTC regulations: 1938 FDCA gave FDA authority to approve pharmaceutical marketing Evolution of DTC regulations: 1969 FDA issued regulations: 1. not false or misleading 2. fair balance 3. include facts of product's advertised uses 4. include brief summary of risks Evolution of DTC regulations: 1983 FDA issues voluntary suspension on DTC advertising Evolution of DTC regulations: 1985