W-34: FDA Advisory Committee Meetings: A Five-year Retrospective Analysis

Poster Presenter

Lauren Aronin

Postdoctoral Fellow
St. John's University
United States

Objectives

To provide a descriptive analysis of FDA Advisory Committee Meetings that occurred between 2013 and 2017.

Method

Public data from FDA regarding Human Drug Advisory Committee Meetings that were held between January 2013 and December 2017 were reviewed and analyzed using Microsoft Excel. Any Advisory Committee that did not hold a product specific meeting during this period was excluded from this analysis.

Results

The Agency currently has eighteen standing Human Drug Advisory Committees. Between January 2013 and December 2017, 125 product-specific Advisory Committee meetings were held, 30.4% of which were held for NMEs. The Oncologic Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee met most frequently, 21 and 20 times respectively over the five-year period. The Gastrointestinal Drugs Advisory Committee, Medical Imaging Drugs Advisory Committee, and Antiviral Drugs Advisory Committee met least frequently, just twice each over the five-year period. Of the 264 NME/BLA applications submitted to FDA between 2013 – 2017, only 38 Advisory Committee meetings were held for NMEs.

Conclusion

Given the substantial effort that goes into preparing for Advisory Committee meetings, it is essential for sponsors to consider both FDA goals and Advisory Committee trends. This analysis found that between 2013 and 2017 FDA did not hold an Advisory Committee meeting for each NME application as required by the Food and Drug Administration Amendments Act (FDAAA) of 2007. Although it is unclear as to why this requirement is not being met, it may be due to lack of internal resources or Advisory Committee recruitment challenges. Alternatively, FDA may have justification for not holding an Advisory Committee meeting for each NME application, but this information was not included in publicly accessible documents and therefore cannot be assessed. Including a rationale in the filing or mid-cycle communication would be beneficial to both sponsors and the public to gain a better understanding of Advisory Committee meetings.