FDA Advisory Committee Training An Industry Representative Perspective Alison Lawton Sr. VP Regulatory Affairs Genzyme Corporation

Background to Industry Representative Introduced in FDA Modernization Act Non-voting member, non–SGE – Financial interest disclosure Conflict of interest? – Personal example

Process for Nomination Federal Register notice published Industry organizations interested send a letter within 30 days FDA requests organizations to consult in selecting candidate (if more than 1 identified) Single nominee provided to FDA within 60 days

How is the Industry Rep. Selected? Industry Associations poll members for nominees Nominees are reviewed by appropriate committee e.g. PhRMA RACC – Education, knowledge in subject, industry experience Industry Associations agree on a single nominee Nominee details sent to FDA

What is the role of the Industry Rep.? Represents global concerns for industry (not their own company) Provide industry perspective to discussions e.g. cost or practical application of a proposal, regulatory standards Speak with industry &/or sponsor before meeting to ensure appropriate representation