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FDA Advisory Committee Preparation Tips

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1.     Understand the history of the issue and how it was raised to the level of FDA interest.

2.     Learn the goals of the advisory committee and the questions they will be asked to vote upon. Advisory Committees members provide advice to the FDA, based on 4-5 questions the FDA asks the committee members to vote on. Sample questions include:

·      Is there reasonable assurance that X device is safe for indications(s) A (and B, etc.)?

·      Is there reasonable assurance that X device is effective for indications(s) A (and B, etc.)?

·      Do the benefits of X device for indication(s) A (and B, etc.) outweigh the risks of device X for indication(s) A (and B, etc.)?

3.     Get to know the members of advisory committee to understand their positions and be able to address them specifically on issues that are important to them.
The Medical Devices Advisory Committee, Circulatory System Devices Panel

4.     Familiarize yourself with the process, the cadence of the hearing, the room itself.

SAMPLE AGENDA

·             Introduction

·             Conflict of interest

·             Presentation by sponsor, 30-60 min

·             Presentation by FDA

·             Open Public Hearing, 30-60 min

·             FDAs questions for the committee; Committee discussion and deliberation;

·             Vote and discussion

There are laws that govern how ACs are set up -- Federal Advisory Committee Act. There are also FDA regulations and guidance’s that talk about public engagement and votes the committee can take.  You can get an idea of some questions they may ask from the four items noted in the FDA Notice.  See FDA.gov.

Daniel Cherrin

DANIEL CHERRIN |served the City of Detroit as its Communications Director and the Press Secretary to Detroit Mayor, Ken Cockrel, Jr. He is a public relations + affairs specialist who just happens to be a lawyer, with 20 years of experience providing senior public relations and government relations’ counsel to organizations on state and federal regulatory and legislative matters, as well as issues affecting corporate and individual reputation, crisis management and the media. Daniel is the founder of NORTH COAST STRATEGIES (Est. 2005) an independent public relations consultancy that combines the best of a big agency with hands-on executive-level experience and support. As a signatory company to the United Nations Global Compact, we are dedicated to addressing issues around human rights, labor, the environment, and anti-corruption. We are also focused on redefining your brand and changing the conversation to create an impact.