FDA Advisory Committee Training

An Industry Representative Perspective

Alison Lawton

Sr. VP Regulatory Affairs

Genzyme Corporation

Background to Industry Representative

Introduced in FDA Modernization ActNon-voting member, non–SGE

– Financial interest disclosure

Conflict of interest?– Personal example

Process for Nomination

Federal Register notice publishedIndustry organizations interested send a

letter within 30 daysFDA 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

experienceIndustry 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