Implementation Considerations

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Presentation transcript:

Implementation Considerations PhRMA DTC Principles Implementation Considerations 12/5/2018 Lucy Rose and Associates, LLC - no copying without permission

Lucy Rose and Associates, LLC - no copying without permission Submit New TV Ads to FDA Companies should submit all new direct-to-consumer television advertisements to the FDA before releasing them for broadcast. How far in advance? Request for review not stated necessary What format? Storyboards, rough cut, final? Review Timing – FDA resources? How does a company/FDA define “new?” Same ad, different language? When is a “tweak” a “tweak”? 12/5/2018 Lucy Rose and Associates, LLC - no copying without permission

Lucy Rose and Associates, LLC - no copying without permission Reminder Ads? DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised. Essentially does away with reminder ads Assumption that all TV ads are either branded ads or disease state Only “major risks”? How does this comport with the FDA interpretation of risk communication? 12/5/2018 Lucy Rose and Associates, LLC - no copying without permission

Lucy Rose and Associates, LLC - no copying without permission Benefit/Risk Balance DTC television and print advertising should be designed to achieve a balanced presentation of the benefits and risks associated with the advertised prescription medicine. Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals Seems in concert with the FDA regs. Clearly states that PhRMA supports this concept FDA has taken significant action regarding minimization of safety 12/5/2018 Lucy Rose and Associates, LLC - no copying without permission

Lucy Rose and Associates, LLC - no copying without permission Educational Time Companies should spend an appropriate amount of time to educate health professionals about new medicines or new therapeutic indications before beginning the first direct-to-consumer advertising campaign. In determining “an appropriate time,” companies should consider the importance of informing patients of the new medicine, the complexity of its risk-benefit profile, and health care professionals’ knowledge of the condition being treated. Companies should continue to educate health care professionals as additional valid information about a new medicine is obtained from all reliable sources. What does the term “valid” mean and what does this mean for off label promotion, if anything? Test of substantial evidence? What is a “reliable source?” Subjective…What does this mean for FDA and industry? 12/5/2018 Lucy Rose and Associates, LLC - no copying without permission