Table 2

Legal Compliance Index: ranking of new drugs according to their compliance with disclosure requirements under the Food and Drug Administration Amendments Acts (FDAAA)

Drug*CompanyIndicationFDAAA definition 1: ‘controlled’ trialsFDAAA definition 2: ‘interventional’ trials
No. trials subject to FDAAATimely registration (%)Timely reporting (%)FDAAA compliance (%)No. trials subject to FDAAATimely registration (%)Timely reporting (%)FDAAA compliance (%)
ElelysoPfizer/ProtalixGaucher disease110000310000
StivargaBayerColorectal cancer110000210000
PerjetaGenentech/RocheBreast cancer2500025000
SigniforNovartisCushing’s disease110000210000
ErivedgeGenentech/RocheBasal cell carcinoma210000310000
ZioptanMerck/SantenEye-pressure, glaucoma71717177291414
EliquisBMSAnticoagulant68333336833333
AubagioSanofiMultiple sclerosis78671717867171
ZaltrapSanofiColorectal cancer6100676791007878
InlytaPfizerRenal cell carcinoma210010010071008686
StribildGileadHIV31001001003100100100
XeljanzPfizerRheumatoid arthritis1110010010011100100100
BosulifPfizerLeukaemia11001001002100100100
MenHibrixGSKMeningitis vaccine, children31001001003100100100
SirturoJanssen (J&J)Tuberculosis11001001002100100100
Median2100676731007171
IQR1–693–1000–1000–1002–793–1000–1000–100
  • *For a list of the active ingredients for these drugs (see online supplementary appendix 2).