AMCP Update: FDA Preapproval Information Exchange

Webinar Recorded on October 30, 2018 

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Payors have indicated interest in receiving information from manufacturers about medical products that are not yet approved/cleared by the FDA for any use, and about unapproved uses of approved/ cleared medical products. This information may allow payors to plan and budget for future coverage and reimbursement decisions prior to FDA approval.

FDA provided final guidance on Pharmaceutical Information Exchange in June 2018. AMCP has been involved throughout the process- advocating, presenting and supporting members’ needs, as well as providing communication to both members and manufacturers.

This webinar will provide an overview the current state of AMCP activity, and present perspectives from manufacturers and payors, specifically:

  • Information on the final FDA guidance on preapproval information exchange
  • Survey results from a 2018 manufacturer survey on PIE communications conducted by AMCP and Xcenda
  • Payor perspective the value and use of PIE communications – identifying current experience as well as expectations from manufacturers
  • Manufacturer perspective in developing and disseminating PIE communications
  • Current and future activities by AMCP regarding PIE initiatives


  • Mary Jo Carden, RPh, JD
    Vice President, Government & Pharmacy Affairs
    Academy of Managed Care Pharmacy
  • Amy Duhig, PhD
    Senior Director, Outcomes Research
  • Iris Tam, PharmD
    Director and Head, Outcomes Research & Quality of Care, Medical Affairs