FDA Advisory Committee Member Practices and Preferences: A Survey on CDER Panel Member Influences
We conducted a survey of approximately 2,500 current or former members of one of the FDA’s Drug, Device, and Biologic Advisory Committees (ADCOMs) to assess their ADCOM meeting preparation practices and preferences. This article focuses on 2014 results as reported from members or former members of a number of ADCOMs.
FDA ADCOM meetings continue to play an important role in the medical product approval process. With advancements in immunology and 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 ADCOMs. Preparation on behalf of all involved – sponsors, panel members, and the FDA – is critical for a successful ADCOM meeting.
Additionally, because the outcomes of these meetings influence the agency’s overall decision to approve a product, it is important for sponsors to understand who their ADCOM members are and what influences their votes. 3D Communications has found that understanding trends in ADCOM member practices and preferences is crucial in preparing for an ADCOM meeting.
Overall, the findings suggest that:
- Sponsors must prepare well-written, concise, data-driven materials to increase the successful outcome of their ADCOM meetings
- ADCOM members rely on the FDA and sponsor’s materials in determining their position
- Thoughts and opinions of the public and patients have an impact