FDA seeks views for e-submission platform

The Food and Drug Administration plans to completely move to electronic submissions of reporting for regulated drug products and to create a common electronic platform to exchange data.

The agency of the Health and Human Services Department today heard from 24 companies and organizations about how to accelerate that process and the issues involved in contracting some of those services.

FDA, over several years, has migrated to e-submissions for some aspects of regulatory reporting, such as the content of drug labels, but the adoption is voluntary in most instances. FDA also has issued guidance for an electronic common technical document format and for selected drug pre-market and post-market information. The agency has collaborated with manufacturers, health care information suppliers and other federal agencies to develop data standards and to build databases for sharing certain clinical-trial information.

An electronic environment would promote patient safety and better health outcomes, and improve the ability of consumers and their health care providers to make better informed decisions about the use of medical products, FDA said.

Large pharmaceutical companies already conduct electronically much of their reporting and communication with FDA related to gaining market approval and post-market follow up, said Janet Woodcock, FDA deputy commission for operations, at the hearing. For others, FDA will have to step up its advocacy, she said. FDA has more foundation work on which to develop a common electronic platform to support the exchange of clinical research information and other regulatory data.

“We may have standards in some areas, but we don’t have a network approach,” Woodcock said.

Terence Zagar, chief technologist at Northrop Grumman Corp.’s Health Solutions and Life Science division, cited collaborative activities to develop a nationwide health information network as an example of how to proceed. Northrop Grumman is one of four HHS contractors developing prototype architectures for NHIN.

In another view, FDA should make e-submissions a requirement and understand that metadata and infrastructure are just as important as the content in e-submissions, said Albert Edwards, director of regulatory affairs for TAP Pharmaceutical Products Inc. of Lake Forest, Ill.

“It is truly time to put away our perceived differences and move e-submissions from the 3-5 percent participation level to a 95 percent + level within the next two years,” he said.

To advance to the fully electronic environment, Edwards urged FDA to develop:

  • Interoperability among systems

  • Standards for e-submissions

  • Consistency of IT service providers for lengthy drug product lifecycles

  • Incentives for electronic adoption.



Industry and the public have until Feb. 16 to comment on the electronic initiatives.

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