Table 3

Compliance with FDAAA legal disclosure requirements 

‘Trial completion date’ interpretation‘FDA approval date’ interpretation
DrugNDA sponsorIndication# Trials analysed% Registered% Reported% FDAAA compliant# Trials analysed% Registered% Reported% FDAAA compliant
DalvanceDurata/AllerganSkin infection2500025010050
FarxigaAstraZeneca*Type 2 diabetes171001212171005959
HarvoniGileadHepatitis C271005959271007070
SivextroCubist/Merck*Skin infection4100757541007575
Xigduo XRAstrazeneca*Type 2 diabetes131002323131007777
Viekira PakAbbvieHepatitis C131007777131009292
ZerbaxaCubist/MerckUrinary and abdominal infections6100006100100100
ZontivityMerckSharpDohmeThrombotic cardiovascular events3100003100100100
LynparzaAstraZenecaOvarian cancer710071717100100100
EsbrietGenentech/Roche*Pulmonary fibrosis410075754100100100
InvokametJanssen/J&J*Type 2 diabetes15100878715100100100
CerdelgaGenzyme/SanofiGaucher disease31001001003100100100
XtoroAlcon/Novartis*Otitis externa21001001002100100100
ZykadiaNovartisLung cancer11001001001100100100
Quartile 131000031007575
Quartile 313100878713100100100
  • Full FDA-approved indications are listed in the online supplementary appendix 6.

  • *Some trials for this drug were sponsored by a company other than the New Drug Application (NDA) sponsor, including the below.

  • Farxiga:  AZ reports that this drug approved by the FDA on 1 January 2014 and acquired from BMS on 2 January 14. AZ states that ‘the transition of Farxiga studies to AstraZeneca is still in progress. Results were to be posted before the transition to AstraZeneca, which did not occur within the timeline for newly approved products’. AZ has now posted results for the seven FDAAA-applicable studies that did not meet FDAAA requirements. Six out of seven were published in the medical literature on or before 30 days post FDA approval; the other was published after the 30-day cut-off.

  • Sivextro: Bayer/Trius sponsored four trials, three out of four were FDAAA compliant under the ‘approval date’ interpretation.

  • Xigduo XR: BMS cosponsored 10 trials with AstraZeneca, 9/10 were FDAAA compliant under the ‘approval date’ interpretation.

  • Esbriet: Intermune sponsored two trials, both were FDAAA compliant under the ‘approval date’ interpretation.

  • Invokamet: Mitsubishi Tanabe sponsored two trials, one out of two was FDAAA compliant under the ‘approval date’ interpretation.

  • Xtoro: Alcon sponsored two trials, both were FDAAA compliant under the ‘approval date’ interpretation.

  • AZ, AstraZeneca; BMS, Bristol Myers Squib; FDA, Food and Drug Administration; FDAAA, Food and Drug Administration Amendments Act; NDA, New Drug Application