Table 2. Frequency of off-label marketing strategies and practices reported in PMCPA rulings (2003–2012) and US whistleblower complaints (1996–2010).
| Descriptor | UK Cases, n/N (%) | US Whistleblower Complaints, n/N (%) 1 |
|---|---|---|
| Off-label marketing strategies | ||
| Expansion to variation of approved indication | 37/74 (50%) | 22/41 (54%) |
| Different patient subgroup | 20/37 (54%) | 10/22 (45%) |
| Expansion to different disease entity | 29/74 (39%) | 35/41 (85%) |
| Similar symptoms, different disease | 15/29 (52%) | 17/35 (49%) |
| Expansion to variation of approved dosing schedule | 28/74 (38%) | 14/41 (34%) |
| Off-label marketing practices 2 | ||
| Prescriber-related | 72/74 (97%) | 41/41 (100%) |
| Internal practices | 2/74 (3%) | 37/41 (90%) |
| Payer-related | 2/74 (3%) | 23/41 (56%) |
| Consumer-related | 3/74 (4%) | 18/41 (44%) |
1 Data adapted from Kesselheim et al. [34].
2 US whistleblower complaints report specific practices not present in UK rulings, e.g., ghost-writing, giving free samples to prescribers, and discussion with prescribers about how to ensure reimbursement (not shown). UK rulings mostly report dissemination of print material: see Table 3.