FDA answers IT wake-up call

Beleaguered by a series of high-profile food and drug recalls, the FDA has struggled in recent years to maintain consumer confidence and respond to critics who claim the agency is ill-equipped to carry out its mission of ensuring the safety of food and medical products. Improving IT at the FDA is widely seen as crucial to making the agency more effective.

That’s why a report expected to be released this month by the FDA’s Science Board is a welcome bellwether. Written by the Board’s IT subcommittee, it concluded the FDA has made “excellent progress” toward architecting a new agency-wide IT design, and creating an IT foundation capable of supporting the agency mission.

The next challenge, it said, is execution and adoption, specifically in the realm of data harmonization.

The findings are significant because two years ago, the Science Board had roundly criticized the agency for maintaining systems incapable of supporting the FDA mission.

“The progress made by the agency was definitely on the high side,” said Dr. Sangtae Kim, who chairs the IT subcommittee and oversaw the report. “We saw alignment between design and plans, with the designs being led by the FDA’s [chief technology officer], so that knowledge and continuity will remain in-house,” said Kim.

“The main concerns we see now are of implementation” and costs, he said.

The subcommittee concluded that the agency’s IT architecture plans were adequately funded and supported under a $2.5 billion, 10-year data center migration project called the Information and Computer Technology for the 21st Century (ICT21). Awarded in 2008 to 10 contractors, ICT21 provides data management, data warehousing, IT infrastructure and IT security at the FDA.The subcommittee also vouched for the staff as capable of carrying out the IT architectural plan. “The FDA has a strong IT management team with a sound plan for enhancing infrastructure and applications.” said Dr. John Halamka, chief information officer of Harvard Medical School, and a member of the subcommittee that produced the report.

But the subcommittee’s report was not all roses. In assessing the FDA’s ability to harmonize its data standards, the panel noted that details for migrating to standards-based electronic data exchange remain to be developed, recommending that the agency agree to specific goals, objectives and performance metrics.

The data harmonization effort “places significant demands on the time of program staff that is already overburdened,” it said, resulting in a “challenge to accelerating and sustaining this effort.”

As a regulatory agency, the FDA should also use its authority to accelerate data standards adoption throughout industries that the FDA regulates, according to the report.

The subcommittee recommended that the FDA expand its workforce, but acknowledged doing so would be a challenge. A shortage of expertise in healthcare data standards in the industry will make attracting new talent more difficult, it said.

Looking forward, the subcommittee recommended that the FDA commission a review of another large IT component at the FDA: scientific computing. The review should include an assessment of high performance computing, it said, with particular attention paid to how the FDA can best migrate legacy applications and provide desktop support for scientific computing.