FDA CIO: Agency Needs Industry Prod to Take Standards Lead

The FDA should take the lead in establishing industry electronic submission standards but is not likely to do so with any speed unless pushed by companies, vendors and others in the industry, according to the FDA’s acting chief information officer.

A dominant presence should step forward in the healthcare arena to speed adoption of standards for technology as it has in the banking and travel industries, said Fred Farmer, the FDA’s acting CIO, last month at a CIO executive forum event in Washington, D.C., which was cosponsored by Adobe and SAFE-BioPharma Association.

In the healthcare arena, that dominant force is the FDA, he said. But he acknowledged the agency’s culture and history make it “reticent” to step in and impose any standards on industry.

“I’m calling on industry to show a grounds-well of support” by telling the FDA it wants the agency to take the lead on setting standards for esubmissions, Farmer said. He has been with the FDA for almost three years, but took the reins as CIO from James Rinaldi four months ago. Industry should “tell the FDA to lead [on this], that it is [the agency’s] job,” Farmer told attendees. He also urged individual companies and other stakeholders — and organizations like SAFE-BioPharma — to become more active in standards discussions.

Investing time and money in standards can be a tough sell for industry, acknowledged Carol Rozwell, research vice president of life sciences at Gartner Research. The long-term benefits of standards are “definitely there,” she noted, citing operational speed as a most obvious example, but the business case is difficult to spell-out in the short-term.

Rozwell called on industry to also participate more in standards forums and pressure vendors to produce products that are standards compliant. She also urged vendors to focus more on interoperability and interdependability. Data interchange is only part of the story, she said. Industry and vendors must understand that good standards are ever-changing.

Focus on Standards

“Standards are the next frontier we have to tackle in this industry,” Farmer said. He outlined what he described as the three barriers to esubmissions at the FDA:

Secure Exchange: There must be trust between sender and receiver about confidentiality, integrity and availability of the edata being exchanged. “We’re doing pretty well in these areas,” he said. But it is important not to take it for granted. A single failure could set the whole program back months or even years, he stressed.

Standards: While the agency is stronger in setting edata standards, it still has a lot of work to do regarding the processes around that data. “We’re very weak right now,” Farmer admitted. The agency must work toward developing process standards across centers and program areas. Lest anyone become too discourage, though, Farmer noted the agency is currently lodged in the “most frustrating part of the transition.” He expressed optimism that with budget increases and work on process, the agency could achieve its goals. “Esubmissions are inevitable, the real question is the pace,” he said.

Tools: Here the agency is relying even more on industry to develop the tools that will make esubmissions so compelling that they will displace paper for even the most stubborn, traditional user, he said.

Saying he personally believed the FDA should step forward and lead the way on establishing standards, Farmer — brought out of semiretirement by Rinaldi before the latter left the agency to become CIO of NASA’s Jet Propulsion Laboratory — joked that he was a bad guy for the agency to have around because “I don’t need the job and I have a lot of opinions.”

SPL Shortcomings

Farmer also acknowledged shortcomings with the FDA’s internal preparations for its Oct. 31, 2005 launch of the structured product labeling (SPL) format for certain human drug labeling submissions. “Internally we had some bumps and bruises,” he said. Citing it as a lesson for the agency, Farmer said the FDA didn’t do as good a job as it should have preparing its internal users for the electronic labeling information processing system (ELIPS) program. He also noted there was some industry reluctance to participate. The agency noted a large spike in filings before the Oct. 31 SPL filing deadline — especially with annual reports — to avoid the new requirements for one more cycle.

Ultimately, the challenge is convincing people to give up their traditional ways of doing their jobs. Farmer noted it will be challenging for the entire industry — regulators included — to ditch paper for esubmissions. “People are devoted to paper,” he said. It’s the mode most people are comfortable with today, and it is no easy task to get them to change. “The challenger has to knock the champion out,” Farmer said.— Michael Causey