Table 1.
Characteristics of Outpatient Prescription Drugs That Received FDA Approval Between 2013 and 2017
| Characteristic | n (%) |
|---|---|
| Total sample | 109 |
| Year of approval | |
| 2013 | 21 (19%) |
| 2014 | 23 (21%) |
| 2015 | 28 (26%) |
| 2016 | 11 (10%) |
| 2017 | 26 (24%) |
| CMS protected class | |
| Yes | 34 (31%) |
| No | 75 (69%) |
| Inclusion in FDA's expedited programs | |
| Yes | 56 (51%) |
| No | 53 (49%) |
| Added therapeutic benefit | |
| Yes | 27 (25%) |
| No | 64 (59%) |
| Data not available | 18 (16%) |
| Orphan Drug Act designation | |
| Yes | 38 (35%) |
| No | 71 (65%) |
| First‐in‐class | |
| Yes | 35 (32%) |
| No | 74 (68%) |
| FDA approval with randomized trial | |
| Yes | 95 (87%) |
| No | 14 (13%) |
| 30‐day cost based on net (postrebate) price | |
| Lowest (<$500) | 35 (32%) |
| Medium ($500‐$10,000) | 51 (47%) |
| Highest (>$10,000) | 23 (21%) |
Abbreviations: CMS, Centers for Medicare and Medicaid Services; FDA, US Food and Drug Administration.