FDA looks toward major IT overhaul

As a small federal agency with a big mission, the Food and Drug Administration has operated for years with underfunded and overtaxed information technology systems.

In 2007, FDA’s Science Board concluded that the agency’s IT systems were obsolete, unstable and inadequate to fulfill its mandate to oversee food, drugs and medical devices. That news came as no surprise to those familiar with the agency. “The IT systems at the FDA have been antiquated for some time,” said Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, a watchdog group.

But the picture might be brightening as FDA gains a higher profile in the Obama administration, receives a boost in funding to $3.3 billion and continues to take steps forward on its IT modernization efforts. Several large acquisition vehicles are already in place at FDA to obtain contractor support for the work.

Recent developments show signs of an agency flexing new muscles and preparing for a new stage of growth.

• In February, in a follow-up to its 2007 report, the Science Board praised the FDA for excellent progress in the past two years to address IT shortcomings. Work to date has focused on IT infrastructure and data harmonization, and the next phase involves a move to scientific computing.
• Also in February, while many agencies faced stagnant budgets, President Barack Obama asked for a 6 percent increase in appropriated funds and a 23 percent increase when considering appropriated funds and fees to $4 billion overall for FDA. “This budget is a partial recognition of the importance of the FDA,” said Ray Bjorklund, senior vice president of FedSources, a market research firm in McLean, Va.
• Although the Government Accountability Office scolded FDA in June 2009 for not having a strategic plan to update its IT systems, work is now happening on that plan. In the coming weeks, FDA is preparing to release a strategic plan for its IT systems, which has been in the works for several months.

“It has been an incredible, exciting time to be here,” said Lori Davis, who became FDA's chief information officer in January 2009 after serving as deputy CIO for 14 months. “We are making a grass-roots effort for consolidation of IT and centralization of IT.” 

Just the Beginning

The plans are still in the early stages, and the future course will depend on whether FDA obtains sufficient funding to carry out its goals. FDA supporters fear that recent advances could stall without budget increases on the order of 20 percent or more.

“There are powerful forces that would like to see a weak FDA,” said Dr. Ned Feder, staff scientist at the Project on Government Oversight watchdog group. “There are very powerful lobbies that do not want and will fight tight controls and regulation.”

The changes planned for FDA include a major data center modernization, replacing 30-year-old infrastructure and adding high-speed capabilities and analytics, Davis said. In addition, FDA’s Investment Review Board is doing a functional review, the agency is installing a high-performance computer for advanced analytics, and it will complete its strategic plan within the next several months, she said. The agency received a 7.5 percent increase in its appropriated funds in fiscal 2010, designated in part for systems improvement.

“This is more money than we have ever had for IT, and we need to use it wisely and strategically,” Davis said. “I am very proud of our IT transformation and modernization.”

Even so, Davis and the Science Board said the upgrade to FDA’s IT systems is still evolving, and additional work lies ahead.

Completing the update to the FDA data center was a huge step, Davis added. “It is the cornerstone for everything else.”

Outside FDA, advocates agree that the agency is moving in the right direction, even though uncertainties remain.

“FDA’s core technology to do its work was awful four years ago,” said Steven Grossman, deputy executive director of the Alliance for a Stronger FDA. “They have done a good job of getting it into shape.”

Lots of Work to Do

Despite a strong commitment from FDA and the White House, with the enormity of the job ahead, there are doubts about how much the FDA budget will realistically expand in the next several years, Grossman added. His organization was disappointed with the 6 percent increase in appropriated funds requested for fiscal 2011 and suggested a 21 percent increase instead.

“We believe the money needs to come in large quantities and not in dribs and drabs,” Grossman said.

“Intellectually, there is a full appreciation in Congress that the FDA has a big job, and you need the right systems to do it,” Grossman said. But will the money flow? “That will get played out in the coming years.” 

To facilitate its plans, FDA has several contracts in place that will play a central role in its IT improvements, including the $2.5 billion Information and Computing Technologies for the 21st century contract (ICT-21), a 10-year program in which FDA selected 10 winners, also was awarded in 2008.

Glenda Barfel, director of acquisitions at FDA’s Office of Administration, said a number of task orders are expected under that contract in fiscal 2010 and 2011.

“We expect to have three large awards this year under that contract,” Barfel said.

Boost From Health Care Reform

The prospects for future budget hikes at FDA are better than for many other agencies. For fiscal 2011, the Obama administration has put an emphasis on food safety, which is under FDA’s purview. Health care reform also is driving FDA expansion. “The new focus on heath care reform and improved health outcomes has reinvigorated the need for the FDA,” said Deniece Peterson, manager of industry analysis at Input Inc., a market research firm in Reston, Va.

For the fiscal 2011 budget request, FDA’s proposed 6 percent increase in appropriated funds and 23 percent increase with fees would go in part to its IT programs. “Almost all of our new program areas have an IT component,” Davis said.

The priorities include food safety, public health surveillance and monitoring, improved medical product safety, expanded patient safety initiatives, and modernization of FDA’s regulatory science, including nanotechnology.

For food safety, the IT initiatives include track-and-trace technology, improved data collection and risk analysis. Another $10 million is planned for IT systems to establish, support and maintain the systems for Food Registration and Inspection User Fees.

Additional funding is earmarked for FDA’s IT infrastructure to enable interoperability of regulatory data sharing across the agency's program areas. These enterprisewide IT systems include the Regulated Product Submission framework, Janus program for a common data architecture, Common Electronic Document Room and MedWatch Plus.

FDA’s Sentinel Initiative for post-market product safety would receive an additional $5 million. The agency awarded a $72 million contract to Harvard-Pilgrim Health Care Inc. in January to set up a pilot project for Sentinel.

In looking ahead at FDA IT contracting opportunites, Dan Chenok, senior vice president at Pragmatics Inc., an IT solutions provider in McLean, Va., said he sees reasons for optimism. Pragmatics is on a team that won an ICT-21 contract.

“The FDA has put in the contracts they need for achieving their modernization goals," Chenok said. "They are in the initial stages, but there is a fair amount of movement. They are on the right track. I see some acceleration.”