Table 2. US Food and Drug Administration Disagreements Over New Drug Approvals, Populations Indicated, and the Parameters of Approval by Subject, Leadership, and Discipline (Total Instances)a.
| Variable | Approvals (dissents), No.b | Population or indication, No. | Approval parameters, No. | Other, No. | Total by discipline, No. (%) (n = 155) |
|---|---|---|---|---|---|
| Agency leadership | |||||
| Division director | 9 (1) | 8 | 10 | 6 | 33 (21.3) |
| Office director | 5 (0) | 2 | 8 | 4 | 19 (12.3) |
| Cross-disciplinary team leader | 8 (4) | 5 | 6 | 4 | 23 (14.8) |
| Agency disciplines | |||||
| Medical | 6 (5) | 6 | 8 | 7 | 27 (17.4) |
| Clinical pharmacology | 2 (1) | 2 | 3 | 5 | 12 (7.7) |
| Statistics | 4 (3) | 4 | 1 | 3 | 12 (7.7) |
| Safety | 1 (1) | 5 | 5 | 1 | 12 (7.7) |
| Pediatric | 0 (0) | 1 | 3 | 1 | 5 (3.2) |
| Chemistry | 4 (1) | 0 | 0 | 0 | 4 (2.6) |
| Nonclinical pharmacology | 1 (0) | 0 | 2 | 1 | 4 (2.6) |
| Office of Scientific Investigations and other reviewers of regulatory issues | 1 (0) | 0 | 1 | 0 | 2 (1.3) |
| Division of Risk Management and other reviewers of the Risk Evaluation and Mitigation Strategy | 0 (0) | 0 | 2 | 0 | 2 (1.3) |
| Microbiology | 0 (0) | 0 | 0 | 0 | 0 (0.0) |
| Total by subject (n = 155) | 41 | 33 | 49 | 32 |
a
In 8 cases, the other party disagreeing with the disciplines listed here was not a member of 1 of the standard disciplines or leadership that are listed here. For example, in the case of the novel therapeutic agent sacubitril-valsartan (Entresto), a reviewer filed a nonstandard unsolicited review containing conclusions with which members of the standard disciplines disagreed.
b
The number in parentheses reflects the number of disagreements in which the discipline (or leadership) was the party recommending against approval. These numbers do not include within-discipline dissents, in which 1 reviewer recommended against approval but the discipline as a whole ultimately supported approval.