HHS Secretary Thompson vows to make "vast improvements" in expediting oncology drug development using the FDA/National Cancer Institute Interagency Oncology Task Force.

"We continue to collaborate, and I am confident that we're going to see some vast improvements in the future," Thompson told a House Energy & Commerce Committee hearing March 10.

FDA and NCI formed the task force in May 2003 to streamline regulatory interactions and accelerate reviews (¹ 'The Pink Sheet' June 2, 2003, In Brief).

Rep. Edward Whitfield (R-Ky.) questioned the task force's effectiveness.

"We hear from small and medium-sized biotechnology companies that the lack of effective communication and coordination between the FDA and the NCI impedes the transfer of new, innovative therapies out of the laboratories and into the hands" of treating physicians, Whitfield said.

The congressman cited an example of an oncology treatment candidate for which "the FDA is requesting certain toxicological studies that have already been conducted in another type of experiment."

"The whole process is slowing down what appears to be, even by surgeons at NCI, a really promising therapy to address cancerous tumors," he said.

"We're already improving, but I'm still not satisfied," Thompson said. He noted outgoing FDA Commissioner McClellan "is not satisfied and neither is [NIH Director] Elias Zerhouni, so we continue to meet."

At an initial meeting in November, the group discussed electronic IND applications and a joint fellowship program (² Also see "Electronic INDs For Cancer Trials Planned Under FDA/NCI Collaboration" - Pink Sheet, 17 November, 2003., p. 17).

FDA and NIH are also collaborating on developing a list of major barriers to drug development (see ³ Also see "FDA Will Fund Research On “Critical Path” Of Drug Development" - Pink Sheet, 22 March, 2004.).

FDA's focus on translational research for pharmaceuticals may be intensifying. The agency is expected to seek legislation for translational research in coming months (⁴ Also see "FDA May Ask Congress For Funds To Boost Translational Research For Drugs" - Pink Sheet, 26 January, 2004., p. 12).

Cancer Drug Development To See “Vast Improvements” In Speed – Thompson

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