FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel infrastructure to conduct post-market effectiveness studies.

Sentinel is an electronic surveillance system that aggregates data from electronic medical records, claims and registries that voluntarily participate and allows the agency to track the safety of marketed drugs, biologics and medical devices. As of August 2015, the Sentinel database includes information from 193 million individuals, 4.8 billion instances of prescription dispensing, 5.5 billion unique encounters and 51 million acute inpatient stays.

The FDA currently uses the system to assess post-market safety issues. However, in a February 3, 2016, workshop, Dr. Woodcock announced that the FDA is in the early stages of adapting the Sentinel infrastructure to develop the “Guardian” system, which the agency intends to use to “actively gather information about the performance of regulated medical products” used in health care. At the same workshop, Dr. Steven Anderson of the FDA’s Center for Biologics Evaluation and Research (CBER) described the Guardian system as a parallel system to Sentinel that will rely on the Sentinel infrastructure to assess product effectiveness. According to Dr. Anderson, the FDA is currently assessing the feasibility of using Sentinel to perform effectiveness studies, and over the next five years, intends to develop the system to support a range of clinical trial designs.

The FDA envisions that the Guardian system will help the agency and external researchers quickly and less inexpensively answer questions about the performance of medical products that would otherwise require expensive, time-consuming clinical investigations to assess. The FDA did not specifically address how the agency intends to use the effectiveness data developed using the Guardian system.

The proposed Guardian system represents the FDA’s latest attempt to harness the power of “big data” and to participate in the changes precipitated by digital health strategies and tools to address FDA priorities. In 2014, the FDA launched its openFDA initiative, which gives the general public access to several of the agency’s public data sets (e.g., adverse event reports). Moreover, in December 2015, the FDA launched a beta version of its precisionFDA platform, which is an online, cloud-based platform that is intended to allow scientists from the public and private sectors to test, pilot and validate existing and new bioinformatics approaches for processing the large amounts of data collected using next-generation sequencing (NGS) technology.

The FDA’s efforts to launch the Guardian system mirror “big data” initiatives by other private and public stakeholders seeking to leverage data capture and data mining to pursue important public health, quality improvement, research and cost-containment efforts.

Michael W. RyanMichael W. Ryan
Michael W. Ryan advises manufacturers, health care providers, developers, and investors on the legal, regulatory, and reimbursement issues that arise during the development and commercialization of medical devices, drugs, biological products, and clinical laboratory testing services. Read Michael Ryan's full bio.


Jennifer S. GeetterJennifer S. Geetter
  Jennifer S. Geetter advises global life sciences, health care and informatics clients on legal issues attendant to biomedical innovation, research compliance, financial relationship management, digital health practices, and global privacy and data security laws. Jennifer represents a broad range of clients. Read Jennifer Geetter's full bio.


Vanessa K. BurrowsVanessa K. Burrows
Vanessa K. Burrows counsels clients on health care law and regulatory issues, with an emphasis on drug, medical device, food, beverage, and pharmacy law. Her broad-based experience also includes the Health Insurance Portability and Accountability Act (HIPAA) compliance, health privacy and security, alcohol beverages and public health. She advises health care entities and their contractors on compliance, regulatory, data sharing, licensing, and enforcement matters. She also counsels clients on compliance with Food and Drug Administration (FDA) regulations and guidance. Read Vanessa Burrows' full bio.

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