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NDA REVIEWS WITH ADVICE OF "OUTSIDE ACADEMIC COMMUNITIES" IS BEING CONSIDERED BY FDA, COM. YOUNG TELLS PMA: PILOT PROGRAMS IN LIMITED AREAS LIKELY AS START

Executive Summary

FDA's next DNA review reforms will be aimed at bringing in more opinions from the scientific community outside the agency and at improving internal document handling procedures, FDA Com. Young told the Pharmaceutical Mfrs. Assn. (PMA) annual meeting on April 15. Previewing the forthcoming "Action Plan" recommendations, which have been the linchpin of his first nine months with FDA, Young emphasized the increased use of outside scientific opinion. "It is imperative," the commissioner declared, "that we interact much more closely with the outside academic communities. We will bring forward a series of plans . . . to make this possible." The changes to be proposed in the final Action Plan, Young said, are intended "to puncture the black box of FDA and have it much more visible to the outside community and have the outside community participate in our reviewing activities." The Action Plan is complete, Young told PMA. FDA is awaiting public announcement of the intended changes by HHS Secty. Heckler before releasing specifics. While FDA has not disclosed details of the Action Plan proposals for the NDA review procedures, it is likely that the agency will initially propose a demonstration program to test several ways of bringing outside expertise into the new drug reviews on a limited basis. Young's reference at PMA to "a series of plans" indicates that the agency may test several methods of incorporating outside advice into the new drug review process. Decentralization Of NDA Reviews, Including Use Of Regional Offices, Urged By PMA The FDA focus on ways to increase outside participation in NDA reviews is being supported by parallel consideration of ways to open up the review process by PMA. An ad hoc board cmte., headed by Roche's Irv Lerner, has been looking at various approaches to get outside help for NDA reviewers. One concept favored by PMA is decentralization of reviews. At the annual meeting, PMA President Mossinghoff reported that the Lerner cmte. has considered recommending that "some of the responsibility for NDA and NDA supplement reviews be transferred to regional FDA offices or to a separate FDA group. Reducing the load of supplement reviews has been a major target of FDA reforms in the NDA rewrite and the pending Action Plan proposal for the medical device and diagnostic approval procedures. To open up the NDA process to outsiders, PMA has floated the idea of using reviewers from a group like the Natl. Academy of Sciences or NIH to complement work by FDA staffers. Young's statements about the use of "outside academic communities" appear to head in a direction similar to the PMA interests. Young characterized the issue of outside reviews as a part of FDA's overall need to attract strong scientific talent. "The recruitment of outstanding personnel" is one of the key issues facing FDA, Young told PMA. In his prepared text for the PMA address, he referred to the "absolutely essential" objective of a "multi-faceted approach to personnel recruitment at FDA." "It is axiomatic," Young's prepared text says, "to say that the quality of FDA's drug review depends on the quality of the FDA reviewer. We must constantly seek to recruit and maintain top-notch people if we are to keep our science up-to-date and interact with industry and academia on a peer basis. We must also be able to draw upon first-rate expertise from outside the agency." "To upgrade FDA's "state of the art, 1953" paper-handling procedures, Young is committed to pushing for user fees to fund a new equipment drive. Young agreed with PMA that user fees for NDA applications should be pumped back into FDA improvements. However, the FDA commissioner specifically suggested earmarking those funds for equipment purchases. "It is unfair," Young said, "to ask industry, or any other group, to work with FDA and provide funding and then use those funds in other areas. We would propose to use those funs to reequip our word processing and information systems, to be able to redo the facilities to bring the reviewing groups together . . . and to refurbish" the system. Top Execs Should Check NDAs To Make Sure They Take Advantage Of Rewrite Summaries FDA is further examining the NDA review process, in the wake of the IND/NDA rewrite revisions, "based on the strong conviction tht American health will profit immensely from new chemical entities, particularly in this switch from an in-patient to out-patient intense treatment mode," Young explained. The commissioner noted that the NDA rewrite reviews should speed up the approval process by eliminating some of the unnecessary work due to unwieldly formatting of applications. 'We will simplify these horrendous appications," Young said. "If any of you, as CEOs, have not looked at your own submissions, please go back at the end of this meeting and look at them. I cannot begin to impress upon you the chilling effects of receiving 150,000 pages of an NDA application or as some supplements are, in excess of, 100,000." The commissioner pointed out that FDA has begun educating agency staff "on the content of the new regulations, and what they mean." He added: "I trust that you are doing the same. I would be very interested to hear from you whether you believe additional public workshops will be helpful to this educations process." The PMA drug approval process cmte. is also looking at document control systems and new ways to submit NDAs as a way to expedite the process. As part of that effort, the assn. task group is looking at the information processing and handling methods of other agencies, such as the Securities & Exchange Commission and Commerce Dept., that are responsible for large amounts of data. Abbott is testing two computerized NDAs in the cardiovascular area. The NDAs are being prepared in computer form by United Medical Corp. ("The Pink Sheet", April 8, T&G-3). FDA is using improved equipment to make its adverse drug reaction reporting system more manageable, Young told PMA. "New reports are now turned around in roughly two weeks," the commissioner said, "and backlogs have become minimal. We belive those improvements represent important progress in an area that has been difficult to manage." Young added: "We will also be moving ahead and looking ahead at new technologies and processing capabilities so that the efficient management of these vast volumes of adverse reaction data will be readily achievable."
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