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Office of Prescription Drug Promotion Enforcement Webinar

Office of Prescription Drug Promotion Enforcement Webinar. Robert Dean, Director, Division of Consumer Drug Promotion Andrew Haffer, Director, Division of Professional Drug Promotion Bryant Godfrey, Regulatory Counsel Team Leader Cynthia Ng, Regulatory Counsel Robyn Tyler, Regulatory Counsel

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Office of Prescription Drug Promotion Enforcement Webinar

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  1. Office of Prescription Drug PromotionEnforcement Webinar Robert Dean, Director, Division of Consumer Drug Promotion Andrew Haffer, Director, Division of Professional Drug Promotion Bryant Godfrey, Regulatory Counsel Team Leader Cynthia Ng, Regulatory Counsel Robyn Tyler, Regulatory Counsel Ernest Voyard, Regulatory Counsel October 29, 2012

  2. Mission "To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers."

  3. EpiPen & EpiPen Jr* Incivek Sodium Ferric Gluconate Complex Kepivance Zmax Xenazine Ampyra *Warning Letters Equetro Ixempra Zovirax Daliresp Amyvid FazaClo* Vantus Tarceva Enforcement Letters

  4. Violations • Omission/Minimization of Risk • Unsubstantiated Claims • Unsubstantiated Superiority Claims • Overstatement of Efficacy • Omission of Material Facts • Broadening of Indication • Inadequate Communication of Indication

  5. Violations (cont.) • Promotion of Unapproved Uses • Inappropriate Reminder Labeling • Misleading Claims/Presentation • Failure to Fulfill “Adequate Provision” Requirement • Failure to Submit Under Form FDA-2253 • Inadequate Presentation of Established Name

  6. Thank you!

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