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Executive Summary

A fellowship program to bring academic scientists to FDA to assist in NDA reviews on a part-time basis is one of three methods the agency plans to use to increase the involvement of outside scientific talent in regulatory activities, according to FDA's "Plan for Action" released July 26. The Action Plan states that the fellowship program "would become a funding source for academic scientists, principally in nearby institutions, who would be willing to participate actively (at least two days per week) in the regulatory process while also pursuing their academic careers." At a July 26 briefing on the plan, FDA Office of Drug Research & Review Director Robert Temple, MD, noted that there is a "need for sources of funding in the academic community." He said FDA hopes "to be a partner in supplying grants and support to people in their institutions in return for their helping with the agency's regulatory activities. Com. Young credited Temple with originating the fellowship idea. The Action Plan cites two other approaches to increasing FDA access to outside scientists. It states that the Center for Drugs and Biologics will seek to "increase use of individual outside expert reviewers in the review process who would serve on a consultant basis" and will try to "recruit as fulltime employees scientists who can carry out both scientific research and regulatory activities." FDA released the Action Plan exactly one year after Com. Young assumed the FDA helm. According to an executive summary of the document, the plan "designates FDA's highest priorities and charts a broad course for the agency's policy and management directions in the years ahead." The plan consists of 10 main points: the new drug review process; the medical device program; post-marketing surveillance; risk assessment; risk management; food safety; nutrition; new technologies; health fraud; and internal management. HHS Secty. Heckler, at a press conference on the Action Plan on July 25, noted that the first goal of the plan will be to implement FDA's NDA regulation revision. She added that she has "signed the final regulation covering the investigational new drug (IND) stage of drug development." Increased access to outside scientists is a keystone in the agency's overall efforts to improve and accelerate the new drug review process. According to the Action Plan, the Center for Drugs and Biologics will "promptly develop and implement pilot programs in at least two drug reviewing divisions designed to facilitate the drug review process while maximizing scientific quality." In addition to improving "access to high quality reviewers," the pilot programs will also be direct "elimination of inefficiencies in the review process," the FDA document FDA recently gave Associate Commisioner for Management and Operations Gerald Meyer the temporary collateral assignment to assist in the management of the new drug approval process. The Action Plan's proposal to delegate sign-off authority could reduce the load on Office of Drug Research & Review Director Robert Temple, MD, who has been closely involved in the sign-off decisions for individual NDAs. The Action Plan also specifies agency plans to improve the review process for supplements to original applications. It states that the Center for Drugs and Biologics "will develop and implement as soon as possible, a substantially upgraded process for reviewing and modifying effectiveness supplements." FDA said the program should include: "establishment of a system of priorities for supplement review" "determination of which supplements can be delegated to Division Directors for final action and which require Office level review" "assessment of recent performance in supplement review and the development of specific goals for improvement" and "development of a system for monitoring the processing and reviewing" of supplements. In additional efforts to improve the current NDA review process, the Action Plan calls for FDA to "explore with the lnstitute of Medicine (IOM) areas in which the IOM, or other appropriate outside groups, might be able to support the agency's efforts." The agency document notes that "possible roles include analysis of specific scientific problems by forming expert review groups or analyses of more global issues." FDA Associate Com. for Planning and Evaluation Gerald Barkdoll noted at the briefing that the agency is developing a "pre-program" on how to implement the Action Plan. "We will be working out and laying out specific objectives and milestones" in the next few months, Barkdoll said. Asked when the pre-plan would be published, FDA Deputy Com. Norris stated that he would make a "commitment" to have the first level of the program available this summer. With his charge to prepare the Action Plan completed, FDA Com. Young's expected move to become HHS Asst. Secty. for Health may be imminent. Young has scheduled an open meeting with all FDA staff for July 30 which could be his farewell appearance as FDA head. Massachusetts College of Pharmacy President Raymond Gosselin, apparently Young's successor, and recently named Deputy Commissioner John Norris, will assume the primary job of implementing the Action Plan.

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