FDA Pursuing a Future Where All Regulated Product Information Is Electronic

Highlights from Axendia’s “FDA e-Transformation” Study

By Daniel R. Matlis

Axendia has recently completed a research study on FDA’s e-Transformation Initiatives. The study identified key organizational and technology initiatives the Agency is undertaking to advance ongoing electronic communication and interactions with the companies it regulates.

We will be sharing key insights and conclusions from the “FDA e-Transformation Initiatives” research study in a series of articles.

To understand the Agency’s rationale and strategy for e-Transformation, we begin this series by sharing our interview with Dr. Armando Oliva, FDA Deputy Director for Bioinformatics. During our conversation, Dr. Oliva discusses transformational activities that promise to usher a new era of electronic interactions between the Agency and its constituents.

The Janus Initiative

In Roman mythology, Janus was the god of gates, doors, doorways, beginnings and endings. He was frequently used to symbolize change and transitions such as the progression of past to future, of one condition to another, of one vision to another.

This is a very fitting name, based on FDA’s intent for the Janus Initiative.

Axendia’s Life Science Panorama Journal (LSP): What is the FDA’s Janus Initiative?

Dr. Oliva: Janus is a high level strategy to better manage structured scientific data for all FDA regulated products. Janus is an Agency-wide initiative to be used by all the centers at the FDA.

A key goal for Janus is to standardize data as they come in though the FDA’s electronic submission gateway.

The initial phase of Janus is to build a study data warehouse to host subject level data about clinical trials.

LSP: How will the Janus initiative impact electronic interactions between FDA and the companies it regulates?

Dr. Oliva: The goal for Janus is to provide a single repository for study data. Sponsors would submit study reports as well as the data sets of the study used in human trials (be it a drug, biologic, device trial).

Janus will also provide standard modern and user friendly visualization, data mining and analytics tools. These tools will enable FDA to analyze data not only within a particular study, but across studies and applications as well as perform comparative analyses be it across multiple devices in the same therapeutic class or drugs across pharmacological class.
Janus will enable the FDA to:

Establish an enterprise-wide data architecture and standards that facilitate the integration of structured scientific data from a wide variety of internal and external sources to create large-scale data-sharing infrastructures to support clinical trials, post-marketing, registration activities, and manufacturing life-cycle activities;

Develop the standards-based scientific data exchange networks that are needed to ensure the quality, safety, and efficacy of medical and consumer products as defined by FDA’s regulatory mandate;Create structured scientific data repositories that support the acquisition, validation, integration, and extraction of data from the increasingly large and complex datasets received by the Agency;
Make use of enhanced analytical, mathematical, visualization, and other computational tools and techniques that enable reviewers to search, model, and analyze data to conduct better safety and efficacy analyses.

LSP: Today, FDA Centers use different structures and formats for their applications, how will Janus work with these differing formats?

Dr. Oliva: Regardless of how the data come into FDA, (e.g. NDA, BLA, PMA) every center and each application type will have its own structure and format, but the study data will look the same across all the centers once standardized. The Agency is relying very heavily on standards from organizations such as CDISC and HL7.

LSP: What is FDA’s involvement in the development of these standards?

Dr. Oliva: FDA is actively involved in the development of standards. We want these standards to be useful, not just for FDA, but for the regulated industry. Standards should meet industry’s business needs and processes so that they work for everybody not just FDA.

These Standards must support electronic reporting of information utilizing common variable name and, terminology code lists of observations. The standards must be flexible enough to model or represent study data that is generated across different studies type, whether it be for a device, drug, biologic or dietary supplement.

The Agency is also working on global applications harmonization with organizations like ICH and GHTF.

LSP: We can’t discuss Electronic interactions between industry and the FDA without touching on Part 11. How will FDA incorporated part 11 into some of the initiatives we have been discussing?

Dr. Oliva: Part 11 is very much in a state of flux. Part 11 only provides for voluntary submission of electronic data. In other words, companies may chose to submit electronically instead of paper, but we still receive study data on paper, and study data submitted on paper is very difficult to review.

Part 11 is not adequate to support Janus. We are proposing new regulation to require electronic submission of study data in a standardized format. The first application of the proposed rule we already announced would cover studies on drugs and biologics.

The long term goal is for all study data across the entire Agency to come in electronically and in a standardized format.

To realize the Janus vision, FDA must require all Industry/Agency interactions be electronic and that’s where additional regulation beyond Part 11 would be required.

LSP: What does the future hold for electronic interactions between FDA and Industry?

Dr. Oliva: I think it’s fair to say that Agency is actively moving toward an electronic world where all regulated product information comes in electronically. I couldn’t tell when that is going to happen, but certainly there are active discussion underway to move to an all electronic submission environment for all FDA regulated product information whether it be, Product quality, Manufacturing, Pre-market, Post market data.

Janus promises to usher a new era where interactions between the agency and its constituents (i.e. industry, and consumers) will be conducted primarily through electronic means.

The promise of electronic interaction would benefit everyone, but “the proof is in the pudding”.

The “FDA e-Transformation Initiatives” research study was made possible by a contribution from MasterControl Inc.

To schedule a briefing detailing findings and analysis on our finding, please contact us at info@axendia.com

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.