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Executive Summary

FDA's Center for Drug Evaluation & Research senior managers are about to embark on a two-and-one-half-day management retreat on Oct. 14 to "establish consensus about the goals and priorities for the Center for the next few years." The retreat, to be held in the Virginia countryside west of Washington, D.C. is meant to "debate and explore" to what extent FDA should help companies develop applications from start to finish. CDER Director Carl Peck, MD, and office directors will meet first, followed by a larger meeting including the division directors from the two Offices of Drug Evaluation. Manuel Sommers, MD, of the Canadian Health Protection Branch, will discuss recent Canadian regulatory changes. In an Oct. 4 speech at the Princeton Drug Development Conference, FDA Commissioner Kessler said that "one of our goals will be to achieve greater consistency among reviewing divisions within the center." The commissioner praised the innovations undertaken by the Pilot Drug Division, including its "peer review mechanism" for drug review, its "emphasis on strategic planning," and the creation of NDA Days. "When innovations such as these prove to be useful," Kessler added, "we must promptly incorporate them into the work we do every day. One of the goals of this retreat, in fact, is to find ways to pull some of these innovative approaches together." Describing the different review approaches as the "sprinter and marathoner," Kessler indicated a preference for having FDA work with sponsors early in the application. A "sprinter" review agency, Kessler said, "focuses primarily on application review; the constant goal is to review the maximum number of applications in the minimum time." A "marathoner" instead "helps applications along by working with the sponsor early in the process" with the goal being "to assist in all stages of drug development so drugs reach the market as quickly as possible." John Harter, MD, Director of the Pilot Drug Evaluation Staff, said, "drug developers and drug approvers need to reach mutual agreement at multiple decision points during the process through detailed evaluation of the data as it is generated." He warned that "to wait until the process is all over and then try to analyze the data . . . is a prescription for the always protracted, sometimes acrimonious review process we currently have." The "peer review" system employed by the Pilot Drug Evaluation Staff gives individual reviewers "the authority to sign off on INDs and NDAs," Harter observed. The "flat" management structure, unlike the traditional "pyramid structure," charges reviewers "with finding problems and solving them." This obligates Pilot Drug reviewers to make decisions, Harter observed; they "can't just pass problems up [to higher authorities]." Harter acknowledged certain problems that have developed in the pilot drug staff's experiments, including "more errors" and "more chaos" because "we don't have standard operating procedures." Currently, Harter assesses his division as being "down on the failure side more than the success side because we've still got a third of the division that is nervous [about the peer review process] and not able to participate as fully as I'd like them to." He added that it is difficult "for people who were in the old pyramid to learn how to deal with this new structure." The pilot drug staff also differs in the way it uses advisory committees early and often in the review process, Harter indicated. He noted that the pilot drug staff now has "more closed sessions than open sessions" and "what used to be internal meetings and end of Phase I, Phase II, even pre-IND [meetings] we now are trying to get those into the advisory committees." Harter said this gives the division more resources and "it gets the advisory committee members more into the process so they understand some of the problems and see some of the problems that occur before the final package." Harter characterized non-approvable letters as being "a much greater drain on our resources than most people realize" and said they do not speed the approval process, but slow it down. The "Pilot Drug Evaluation Staff approach," said Harter, "is, as each drug approval specialist finds a problem or question about his or her area, they communicate it to the company . . . and get an answer as soon as possible so they can finish the particular IND or NDA they are working on." He said this was different from typical FDA practice in "that our approval specialists are attempting to build completed actions or sections of the NDA to put together in the final package which then can be completed." Harter commented that the standard drug review process "tends to focus FDA efforts on getting NDAs off the list, rather than getting the drug approved," and the drug companies "focus their efforts on getting the clock started again," instead of "getting back quality answers to the questions."

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