Current Trends in FDA Advisory Committee Member Practices and Preferences: A Survey on What CDER Panel Members Say Influences Them
We conducted a survey of approximately 2500 current or former members of one of FDA’s Drug, Device, and Biologic Advisory Committees to assess their Advisory Committee meeting preparation practices and preferences. This article will focus on the 2014 results as reported from members or former members of a number of Drug Advisory Committees.
FDA Advisory Committee meetings continue to play an important role in the medical product approval process. With advancements in immunology, medical technology, and efforts to bring biosimilars to US patients, more and more complex product applications are being submitted to the FDA for approval, and thus will likely be coming before Advisory Panels. As such, preparation on behalf of all involved – sponsors, panel members, and the FDA – is critical for a successful Advisory Committee meeting.
Additionally, because the outcome of the meeting influences the Agency’s overall decision to approve a product, it is important for sponsors to understand who their advisory committee members are and what influences their votes. 3D Communications has found that knowing these trends in FDA Advisory Committee member practices and preferences is crucial in preparing for an Advisory Committee meeting.
Overall, the findings suggest that sponsors must prepare well-written, concise, data-driven materials to increase the successful outcome of their Advisory Committee meeting; advisory committee members rely on the FDA and sponsor’s materials in determining their position; and that the thoughts and opinions of the public and patients have an impact on the advisory committee members.
The article first appeared in RAPS, May 2015. Complete the form to view the complete findings.
This study first appeared in RAPS, May 2015.
ABOUT THE AUTHORS
Lara Burgess, PhD, RAC, is a certified Regulatory Affairs professional with a PhD in Behavioral Neuroscience. She uses her academic research background and strong technical writing skills to prepare regulatory documents, including FDA Advisory Committee briefing books. Lara has experience writing and editing in many areas of research and statistics including grant proposals, research protocols, and conference abstracts. Connect with Lara on LinkedIn.
Virginia Cox, JD, is a Senior Consultant and 3D Communications lead. Before joining 3D, Virginia was the Associate Commissioner for the Office of External Affairs at the U.S. Food and Drug Administration (FDA). Her FDA experience, along with her role as a Communications Lead on numerous 3D FDA Advisory Committee projects, uniquely qualifies her to provide important perspectives on this topic. Connect with Virginia on LinkedIn.
Bert Regeer, MD, has 20 years of experience in clinical development strategy, working at some of the largest pharmaceutical companies in the world. Bert uses his expertise in clinical program design, development, and implementation to help clients prepare for FDA interactions and Advisory Committee meetings. His expertise spans both small molecules and biologics in the areas of oncology, cardiology, infectious diseases, and supportive care. Connect with Bert on LinkedIn.