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Bethesda North Marriott Hotel and Conference Center

08 mar 2018 7:00 a.m. - 09 mar 2018 3:00 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advertising and Promotion Regulatory Affairs Conference

Session 2: FDA Draft Guidance and Initiatives

Session Chair(s)

Wayne  Pines

Wayne Pines

President, Health Care

United States

Hear directly from FDA’s Office of Prescription Promotion on the latest guidances related to medical product communications. The agency will share its thinking on communication of healthcare economic information (HCEI) to payers, as well as information for firms about how FDA evaluates firms’ medical product communications that present information that is not contained in the FDA-required labeling for the product, but that may be consistent with the FDA-required labeling for the product. The agency will also discuss the final guidance on product name placement in promotional labeling and advertisements for prescription drugs.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss the latest FDA guidances affecting medical product communications
  • Recognize the FDA’s view on how to communicate with payers
  • Explain the FDA’s view on communicating information that is considered consistent with the FDA-required labeling for that product
  • Describe the FDA’s view on product name placement, size, prominence, and frequency in promotional labeling and advertisements

Speaker(s)

Catherine  Gray, PharmD

Panelist

Catherine Gray, PharmD

FDA, United States

Director, Office of Prescription Drug Promotion, OMP, CDER

Sheila  Ryan, MPH, RAC

Panelist

Sheila Ryan, MPH, RAC

FDA, United States

Acting Director, ODSIR, Division of Supply Chain Integrity, OC, CDER

Elizabeth  Pepinsky, JD

Panelist

Elizabeth Pepinsky, JD

FDA, United States

Health Science Policy Analyst

KEMI  ASANTE, PharmD, MPH, RAC

Panelist

KEMI ASANTE, PharmD, MPH, RAC

FDA, United States

POLICY ANALYST

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