FDA News: Xarelto AF Trial, FDASIA 907 Progress, IT Security Program – Drug and Device Digest

FDA BRIEF: Week of Oct 10, 2016


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FDA analyses conclude that XARELTO clinical trial results were not affected by faulty monitoring device

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Direct Factor Xa inhibitor, Xarelto (rivaroxaban), approved to reduce the rates of stroke and blood clots in patients with non-valvular atrial fibrillation (NVAF)

  • Alere INRatio device, used to monitor warfarin therapy in control group of pivotal ROCKET-AF clinical trial,  recalled due to potential to generate inaccurate results

FDA analyses to assess impact of faulty monitoring device on ROCKET-AF study results

  • Quite likely patients in warfarin arm  received higher doses of warfarin
  • Increased intensity of anticoagulation had modest effect on clinical outcomes
  • Accordingly, the FDA benefit-risk  conclusion for 2011 approval  not changed

Recommendations: No changes in rivaroxaban labeling


Where We Are/What We Have Done – Two Years After Releasing Our FDASIA 907 Action Plan

By: Janice Soreth, M.D.,  Chair FDASIA 907 Steering Committee, Acting Associate Commissioner for Special Medical Programs

Janice Soreth

SECTION 907 of FDASIA- Advance inclusion of diverse populations in clinical trials


  • Action Plan identified 27 discrete actions  within the three priority areas
    • improving data quality
    • encouraging greater clinical trial participation
    • ensuring more data transparency.
  • Draft guidance (2016) “Evaluation and Reporting of Race and Ethnicity Data in Medical Device Clinical Studies.”
  • Update guidanse (2005): “Guidance for Industry Collection of Race and Ethnicity Data in Clinical Trials.”
  • Drug Trials Snapshots, provide information about clinical trials participants and  whether differences in benefits and side effects among sex, race, and age groups
  • Initiative on “Diverse Women in Clinical Trials”  to increase awareness
  • Public service announcements on FDA’s YouTube channel



FDA’s IT Security Program

This chart shows 12(80%) of the 15 Program Recommendations have been remediated.3 of the Program Recommendations are in progress.

Government Accountability Office (GAO), August 2016 report, outlined recommendations for Information security and the protection of industry and public health information

FDA fully implemented

  • 80% GAO’s program recommendations
  • 61% GAO’s technical recommendations
  • Anticipate completing remaining recommendations within next tear

Also implemented processes, procedures and tools to ensure the deterrence, prevention, detection and correction of incidents

Working with the Energy and Commerce Committee and the GAO to ensure the timely closure of their findings.




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