FDA expects to play the role of a "neutral referee" to facilitate external research conducted under the agency's Critical Path initiative.

The agency would act in an advisory role for the various critical path collaborations, FDA Acting Deputy Commissioner of Operations Janet Woodcock said June 27 at the Drug Information Association annual meeting in Washington, D.C.

"In the best of all possible worlds, I think FDA would simply be advising," Woodcock said. "We see all the problems across all the projects. We see what the roadblocks are to development, at least in late clinical and through the rest of development."

"In fact, we aren't funded nor is it really our mandate to improve the developmental process," she added.

FDA involvement in Critical Path projects could lead to a conflict of interest issue, she pointed out, because the agency will eventually be "in the position of deciding whether or not the validation or whatever is adequate."

An advisory role would not necessarily resign FDA to spectator status. "There are a couple of places...where agency involvement is going to absolutely need to take place," Center for Drug Evaluation & Research Acting Deputy Director Douglas Throckmorton said.

"One of the advantages of agency involvement" is that "we are able to look at otherwise commercially confidential information coming in from several sources, integrate it, and in some sense play the neutral referee...to help move something together that otherwise might not move," Throckmorton said.

"The other place the agency could potentially play a role is in facilitating information transmittal to the outside world."

However, FDA's role in the Critical Path initiative may ultimately be determined more by opportunity than by choice.

"We do not have extra resources lying around that can be diverted into this effort, and therefore we have been spending a lot of time trying to set up research consortia of various types," Woodcock said.

One of the goals of the Critical Path initiative is to develop a new form of FDA/industry/academia collaboration to address critical path opportunities (¹ Also see "Biomarker Working Group To Explore Development Of Guidance" - Pink Sheet, 15 November, 2004., p. 28).

FDA has neither established an office nor added staff to manage the Critical Path initiative. "There are several people at the agency level who are working on this full time, publishing a list and trying to set up some of these collaborative efforts," Woodcock said. However, only a "very small" number of staff has been devoted full time to Critical Path.

Consequently, the Critical Path projects that are pursued will in large part be based on the interests of FDA's research partners.

"Given the fact that we don't have any funding, our decisions are kind of opportunity-based, where we have willing partners," Woodcock said.

While FDA is restricted by resource limitations and its regulatory role, industry is also constrained in collaborating on many Critical Path projects, Woodcock noted.

"For many of these projects, we're not even sure FDA should do them," but "industry actually is hobbled," she said. "You can't legally get together and collaborate on some of these things."

Industry also might be hesitant to engage in drug development projects without FDA assurance that they will qualify for regulatory acceptance.

"We certainly want some assurance that what's being done is going to be considered viable," AstraZeneca VP-Regulatory Affairs Steve Miller said.

Office of Clinical Pharmacology & Biopharmaceutical Science Director Lawrence Lesko agreed that FDA should clarify its expectations for acceptable development programs. FDA needs to develop a "prototype model" to define success in the Critical Path context, Lesko said. He mentioned disease-state models as an example.

FDA's Critical Path opportunities list should be released soon, although Woodcock admitted that would be "FDA soon." The list had been delayed by FDA's focus on safety issues (² Also see "Detour On FDA’s “Critical Path:” Safety Issues Divert Agency’s Attention" - Pink Sheet, 13 December, 2004., p. 33). "Soon after that we will publish the follow-on report on what" FDA is "actually working on," she said.

FDA Seeks Advisory Role In Facilitating Critical Path Research

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