Industry Leaders Call for Electronic Submissions Standards Push

Technology innovation and adoption are not hard, but coordinating the accompanying semantics and standards certainly is, said industry leaders.

“This is a passionate call to action,” William Rosen, worldwide regulatory affairs and quality assurance officer for Pfizer, told attendees Feb. 8 at the Drug Information Association (DIA) Conference for Electronic Document Management in Philadelphia. “The pharmaceutical industry has to be a more active partner” in the development and advancement of standards for esubmissions, he said.

His call was echoed by several industry participants who, like Rosen, are members of DIA’s Electronic Regulatory Submissions (ERS) working group. The group is in a “unique position to help advance standards,” said Allan Jones, director of GlaxoSmithKline’s publishing, informatics and archives regulatory operation. The ERS group is comprised of PhRMA members and reports to DIA’s Regulatory Affairs Coordinating Committee (RACC).

Collaboration Essential

The group works closely with the FDA and others, including the Clinical Data Interchange Standards Consortium (CDISC). Most ERS members bring an expertise in erecords and esubmissions issues. Member companies include Amgen, Wyeth, Johnson & Johnson and GlaxoSmithKline. Successfully moving the healthcare industry from a paper to electronic paradigm will require sustained and broad collaboration, stressed ERS member Edward Tripp, program director of esubmissions for Abbott Laboratories.

In recent months the group has made tangible progress in advancing standards for esubmissions through collaborative efforts with the electronic common technical document (eCTD) and structured product labeling (SPL). The group has developed white papers and demo projects and has “come a long way in a fairly short time to advance eCTD [standards],” Rosen said.

But there is a clear need for broader industry standards acceptance in order to keep the momentum going, agreed Tripp.

The group is now working with CDISC on a major survey to uncover and develop information and metrics demonstrating how standards can lower costs and improve efficiencies. Results are slated to be unveiled at DIA’s Annual meeting in June.

The cost savings are already clear, but the survey will help bolster that case — especially to senior management, Jones said.

“We’ve not done a good job of helping senior management understand this is a long-term change,” he noted. “When I ask for more money for eCTD, for example, senior management sometimes says, ‘I thought I already gave you a lot of money for that,’” he said. Senior management needs to understand the long-term return on investment and other operational values of eCTD, Jones said. But senior management also needs to be brought into the discussion at the outset in order to understand the complexity of the project, and that it won’t be accomplished overnight, he said.

Getting Priorities Straight

The ERS working group also delivered a major standards proposal to RACC last month and hopes for its endorsement soon, Rosen said. That proposal is designed to address a major stumbling block in standards work: prioritizing what should be done first, where the industry should be proactive and where it can be relatively passive, he said.

Later this quarter, the group will begin discussing with the FDA how to prioritize and advance esubmissions standards. It hopes to present a full public proposal at DIA’s June meeting.

Despite its progress, ERS members acknowledged they still have a long way to go. “Significant development is still needed for esubmission standards and practices,” Jones said. Part of the issue is recognizing the challenges and opportunities presented by ehealthcare operations that have spread far beyond the pharmaceutical world and into healthcare delivery. — Michael Causey