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Drug Safety Oversight Board Meeting, November 15, 2012


Public Summary
The following are Drug Safety Communications (DSC) posted since the September 20, 2012 meeting and relayed to the Drug Safety Oversight Board (DSB or Board) via memorandum:
  • October 25, 2012:  Over–the-counter eye drops and nasal decongestant sprays:  A DSC was posted concerning the serious harm that can result when children accidentally ingest over-the-counter eye drops used to relieve redness and nasal decongestant sprays.
  • November 2, 2012:  Pradaxa (dabigatran etexilate mesylate):  A DSC update was posted concerning the safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa.  Following the approval of Pradaxa, FDA received a large number of post-marketing reports of bleeding among Pradaxa users.  As a result, FDA investigated the actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of Pradaxa compared to new users of warfarin. The assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative.  The data indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa  
The Board heard seven presentations concerning patient registries.
Use of Registries for Post-approval Product Safety Assessment: Regulatory and Epidemiological Perspectives
Dr. Solomon Iyasu, Director of the Division of Epidemiology I in CDER’s Office of Surveillance and Epidemiology discussed Registries and their role in drug safety assessment.  He discussed the Safety Assessment Framework, FDA’s regulatory authority, the limitations of pre-market data, as well as disease-based registries and issues with single-product exposure registries.
Product-Specific Registries for Safety Evaluation: Challenges & Considerations
Dr. LaRee Tracy, Lead Mathematical Statistician in CDER’s Division of Biometrics VII, Office of Biostatistics within the Office of Translational Science presented on types of registries and their role in the regulatory process, general challenges and considerations when using registries, including specific examples, as well as on the potential role of the federal partners.
Medullary Thyroid Cancer Case Series Registry for Long-Acting GLP-1 Agonists
Dr. Amy Egan, Deputy Director for Safety in CDER’s Office of Drug Evaluation II/Division of Metabolism and Endocrinology Products, presented the ongoing efforts of a post-marketing required study of a medullary thyroid cancer case series registry for the long-acting GLP-1 agonist drug class.
Building Electronic Clinical Data Infrastructure for CER, Drug Safety, QI and Clinical Care
Dr. Gurvaneet Randhawa, Medical Officer in AHRQ’s Center for Outcomes and Evidence an overview of AHRQ electronic clinical data infrastructure projects, governance, informatics and comparative effectiveness challenges, as well as an overview of the EDM Forum and the Registries Handbook.
An Overview of VA Databases and Registries
Dr. Fran Cunningham, Associate Chief Consultant, Medication Safety PBM, Director Center for Medication Safety at the Department of Veteran’s Affairs provided an overview of the VA health care system, including the passive surveillance database.  She also reviewed the administrative databases for QI and drug safety surveillance and provided a brief overview of select VA registries.
Pregnancy Registries for Monitoring the Fetal Effects of Medication Use
Dr. Cheryl Broussard, Epidemiologist in the CDC’s Birth Defects Branch/CDC National Center on Birth Defects and Developmental Disabilities provided an overview of the CDC’s role in Pregnancy Registries.
Evolving Role of Registries in Evidence Generation, Synthesis and Appraisal throughout the Total Product Life Cycle:  A CDRH perspective
Dr. Danica Marinac-Dabic, Division Director in CDRH’s Division of Epidemiology, Office of Surveillance and Biometrics, presented the CDRH perspective on the evolving role of registries in the Device product life cycle.