FDA answers IT wake-up call
By Elizabeth Laipson
Friday, November 20, 2009
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.