FDA's Implementing Visionary: A Conversation With COO John Dyer
FDA's efforts to help usher in the bioinformatics era are personified by Deputy Commissioner for Operations John Dyer.
Dyer, former chief operating officer for the Centers for Medicare and Medicaid Services, has now joined FDA in the same capacity (1"The Pink Sheet" Jan. 29, 2007, p. 16).
The scope of Dyer's responsibilities could be most clearly viewed through a bifocal lens, with the day-to-day job of managing administrative operations within the commissioner's office, and the long-term job of instituting an infrastructure able to sustain a legislative agenda that will far outlast his own term at FDA.
The massive FDA reform bill now awaiting conference promises to overhaul the agency's responsibilities for drug safety oversight - in addition to renewing and tweaking the user fee program (2"The Pink Sheet" May 14, 2007, p. 16).
"To really have [the legislation] up and running and in place by the time I walk out - that's a tall order," Dyer said in a recent interview with "The Pink Sheet."
"When I say 'in place,' I mean thought through, the people have been hired that are going to run it, you've showed that the money and systems support are there, and I know that it will go about happening even though I'll be somewhere else by then," said Dyer, who had planned to return to the private sector before accepting the position at FDA.
Using The Merge Function For Surveillance
While leading the implementation of the Medicare drug benefit at CMS, Dyer had less than one year to bring up 13 new systems - experience that helped prepare him for the system modernizations currently on FDA's agenda.
"We were putting the databases together that warehouse a lot of the prescription drug data, which will be part of the future bioinformatics world," said Dyer, who, prior to CMS, held positions as the chief information officer at the Social Security Administration, as well as commerce branch chief in the White House Office of Management and Budget.
"True bioinformatics," he said, is managing and merging the existing large health care databases to more actively monitor for drug safety and efficacy signals.
At CMS, "we were looking at our [Medicare parts] A, B, and C data, and moving all that data into warehouse type operations from a systems end so that we could start to cross walk the data from A to B to C to D, and we were beginning to start to figure out how to also tie in the clinical data that we had out in the [quality improvement organizations]," Dyer said.
Dyer said the agency is working toward the ability to cross-match that administrative data from CMS - which does not contain the specifics of what the doctor did in a visit - with existing and more specific medical data from organizations such as HMOs.
"From that end, we were starting to talk to FDA and others about how those datasets could be of use to them ... [former FDA and CMS chief] Mark McClellan was obviously interested in it," Dyer said, noting that McClellan, now the director of a new health care group at the Brookings Institution, has been a leading figure in support of a public/private partnership for an active surveillance system.
FDA is involved in several other projects to investigate an active drug safety surveillance system, including one with the Massachusetts Institute of Technology's Center for Biomedical Innovation that employs a system to mine hospital and HMO databases on an ongoing basis to look for patterns (3"The Pink Sheet" Aug. 28, 2006, p. 15).
Many have speculated that such a system would require a public/private partnership, as FDA does not have the resources to institute an active surveillance system on its own, and duplicative efforts from various stakeholders could be counterproductive (4"The Pink Sheet" April 2, 2007, p. 28). Dyer agreed: "This has to be a mix of everybody - state, local, private, hospitals, etc.," he said.
Widespread implementation of such a system is on the horizon, Dyer said. "It's interesting - a year or two ago when I first heard this stuff being talked about, it was sort of viewed as, 'Gee, it's doable, we need to be thinking about it.' Now ... it's, 'We can do it, we know how to do it, the technology is there ... It's really taken a quantum leap.'"
Moving forward, however, depends on appropriations in pending legislation, as existing budget constraints at FDA would make implementation impossible. "We're obviously interested in the legislation that is moving, because if FDARA [the FDA Revitalization Act] has the pharmacovigilance piece, that'll make funds available to us and others, and really pick up speed in this area."
"Everybody I think is at the point now where we all know we're going to do it, and we have some pretty good ideas as to how to do it, but we know that there are issues," including how to establish a governance process, privacy protections, and clear definitions and standards to unify information from a variety of sources.
Getting Industry On Board And In Sync
Developing those standards for industry, especially in terms of submitting drug applications electronically, is crucial for FDA to be able to move to an all-electronic system. "When you start to try to deal with real data and be able to analyze it rather than being stuck with text PDF, you've got to have standards, and we've been working on them and getting them out."
Shortly after his arrival at FDA, Dyer retained a new chief information officer (5Timothy Stitely, from CMS) to lead the agency-wide IT transformation initiatives and establish a plan to rebuild the IT infrastructure to support massive amounts of information electronically.
"The flip side is that same thing from the industry side," Dyer said. "Some of the industry is not that far along in their use of automation, and so they've really got to get to a higher level."
FDA recently issued the first of a series of guidances to help sponsors make regulatory submissions in electronic format.
The 6guidance on the receipt date of electronic submissions lets companies know how FDA determines those important regulatory milestones, such as the review performance goal date under the Prescription Drug User Fee Act. The guidance applies to INDs, NDAs, BLAs, and master files in electronic format.
Under the guidance, all applications have to pass a technical validation check to ensure that the media do not contain deficiencies such as defects, viruses, or incompatible files, and FDA will consider an application "not received" until all technical deficiencies have been resolved.
Once a submission passes the technical validation, the receipt date will be the business day on which the submission arrived at the appropriate agency office. For hybrid submissions - those that contain both paper and electronic files - the receipt date will be determined only after the electronic portion has passed technical validation.
"What I've heard from a lot of folks is that generally," most people support moving ahead towards all-electronic submissions, "there are just a lot of caveats," Dyer said. "I'm not so focused on getting a [regulation] out to mandate it - I'm more focused on ... [being] proactive with industry, and talking through what we do to get there, what the right steps are, and how we go about it. I think everybody's agreed to the end objective."
Dyer said his timeline for moving to an entirely electronic system is "as fast as possible." Though it will take several years, he said, in a few years "we could have the vast majority there."
Currently, about 15 percent of NDAs and BLAs are submitted entirely electronically, about 66 percent entirely in paper, and about 19 percent in combination.
"I think it's going to happen faster than most people think. I think we'll start to see some pay-offs from all of this in less than five years, and then real pay-off in 10."
- Jamie Hammon
This article is reprinted from "The Pink Sheet" – July 30, 2007 Click here to start your 30-day, risk-free trial of "The Pink Sheet" – Top down, comprehensive weekly industry insight and analysis. © FDC Reports 2007 - All Rights Reserved
