BOX 5-4

PhRMA’s 15 Guiding Principles on DTC Advertising (2005)

  • Potential public health benefit

  • Accurate and not misleading

  • Educational

  • Identify product as prescription not OTC

  • Foster responsible communication between patient and provider

  • Educate providers about new medicine or new indication for an appropriate (given all facts about the drug, the condition, etc.) length of time before beginning DTC advertising

  • Working with FDA, alter or discontinue DTC advertising if indicated by new risk information

  • Submit all new DTC TV advertisements to FDA before releasing them

  • DTC TV and print advertisements should inform about non-drug options (e.g., lifestyle and diet change) when appropriate

  • DTC advertisements that identify a product by name should include indications and major risks

  • Design advertisements to present benefits and risks in a balanced, clear way

  • Respect seriousness of conditions and drugs

  • Content and placement should be age-appropriate

  • Encouraged: promote health and disease awareness as part of DTC advertising

  • Encouraged: include information for uninsured and underinsured where feasible

new molecular entities in order to prevent potentially rapid uptake of a new drug about which considerable uncertainty remains.

Rationale for Strengthening Drug Regulation

The “Bully Pulpit” Is Not Enough

A response to the concern about FDA’s limited postmarketing authority (see Box 5-5 for two interesting exceptions) is that FDA has and can use its “bully pulpit,” its influence, to compel action on the part of a sponsor. The committee learned in conversations with and from literature about several former FDA leaders that even in cases where authority was not clear-cut, the

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