FDA HL7 Pilot Project Moves Standards Program Forward

The FDA last week initiated a pilot project to test a Health Level 7 (HL7) data interchange standard for submitting product stability data to the agency. The goal is to establish a voluntary standard that will ensure uniformity in data submissions so that the agency’s reviewers can “more efficiently and consistently display and evaluate product stability data submitted in electronic format,” according to the FDA announcement in the May 16 Federal Register.

Product stability data is required in marketing applications and certain other submissions to the agency. Companies currently provide this either on paper or in portable document format (PDF) computer files. If the pilot project works out, companies would have the option of using the new standard when providing this information in new or abbreviated new drug applications, investigational new drugs, new or abbreviated animal drug applications and investigational new animal drugs.

“It’s moving forward at a good pace,” said Ken VanLuvanee, president and CEO of APYX and a member of a related working group charged with developing standards to help facilitate the actual transport of a regulatory submission. His group is about a year away from a test with the FDA, he said.

The new HL7 standard is based on extensible markup language (XML), a next-generation internet programming language and has been more than five years in the making, with prototypes first unveiled at a January 2001 FDA public meeting. HL7, which is a standards development organization accredited by the American National Standards Institute (ANSI), has been working on the standard since then. ANSI formally endorsed the standard last October.

The FDA and its industry partnership have ambitious goals for the Janus cross-trial database this year, Wayne Kubick, senior vice president at Lincoln Technologies, said in March (PIR, March 15).

Aligning Data Standards

Goals include unveiling a complete version 2 of the trial design model and posting new domain models for microbiology and imaging, as part of a broader Clinical Data Interchange Standards Consortium (CDISC) effort with the FDA and HL7 to align data-storage standards, Kubick noted.

CDISC is an open, multidisciplinary, non-profit organization that has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC’s mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

If all goes as planned, the various pilots and projects will eventually allow FDA-regulated life science companies to generate and collect edata in one format and use that same format throughout the entire life cycle of the drug or therapy, he noted. “It has the potential for a lot of cost and time savings,” noted VanLuvanee.

The agency is asking that companies interested in taking part in the HL7 pilot project submit written or electronic requests by July 17. There is no deadline for comments on the pilot project. The full document on the pilot project can be accessed at http://www.fda.gov/ohrms/dockets/98fr/oc05312.pdf. — Martin Gidron, Michael Causey