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 Ernest Voyard, Regulatory Counsel October 29, 2012

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."

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

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

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

Thank you!