Table 1.
Characteristics of FDA Advisory Committee Meetings, 2008‐2015
| Medical Product, Regulatory, and Advisory Committee Meeting Characteristics | |
|---|---|
| Year, No. (%) | |
| 2008 | 41 (11) |
| 2009 | 65 (17) |
| 2010 | 46 (13) |
| 2011 | 47 (13) |
| 2012 | 56 (15) |
| 2013 | 46 (12) |
| 2014 | 43 (11) |
| 2015 | 32 (9) |
| Advisory Committee, No. (%) | |
| CDER | 291 (77) |
| − Antimicrobial | 47 (13) |
| − Oncologic | 37 (10) |
| − Endocrine and Metabolic | 34 (9) |
| − Cardiovascular and Renal | 30 (9) |
| − Pulmonary and Allergy | 27 (7) |
| − Other Drugs | 116 (31) |
| CBER | 24 (6) |
| CDRH | 61 (16) |
| Action Type, No. (%) | |
| Approval | 271 (72) |
| Supplemental Indication | 78 (21) |
| Safety | 27 (7) |
| Orphan Designation, No. (%) | 88 (23) |
| Special Regulatory Program, No. (%) | 153 (41) |
| Members with COI, No. (%) | |
| Any | 57 (15) |
| Product Sponsor | 22 (6) |
| Product Competitor | 45 (12) |
| Median No. Public Speakers (IQR) | 3 (1‐8) |
| Median Percentage of Favorable Public Speakers (IQR) a | 90 (50‐100) |
| Median No. Media Mentions (IQR) | 0 (0‐1) |
a
Among committees with public speakers (n = 308).
CDER = Center for Drug Evaluation and Research; CBER = Center for Biologics Evaluation and Research; CDRH = Center for Devices and Radiological Health; COI = conflicts of interest; IQR = interquartile range.