"Vast Improvements" In Oncology Drug Development Speed Pledged By HHS’ Thompson
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA/National Cancer Institute task force is working to streamline regulatory interactions; Rep. Whitfield questions the collaboration’s effectiveness.
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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. The group met for the first time in November to discuss electronic IND applications. 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 one 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 asserted. "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." - Benjamin Lum |