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FDA DRUG AND BIOLOGIC CENTERS GAIN 201 POSITIONS IN FY 1993; AGENCY TO PROPOSE TECHNICAL AMENDMENTS TO USER FEE STATUTE INCLUDING SHARED MANUFACTURING

Executive Summary

FDA's centers for drug and biologics evaluation and research have added a total of 201 new positions during the current fiscal year, Deputy Commissioner for Management and Systems Mary Jo Veverka reported Aug. 26 at a meeting with industry in Philadelphia on implementation of the user fee program. As of Aug. 7, CBER had hired "124 new staff" with an additional 85 in the process of joining the agency, Veverka said. During FY 1993, CBER is authorized to have a staff of 758 positions, 75 of whom are to be funded by user fee revenues. At the start of FY 1993, there were 655 positions at CBER. Veverka pointed out that most of the new CBER staff are going to the Office of Therapeutics Research & Review, where "about 62 new people already [have] been brought on board and an additional 22 [are] in the works." CDER's drug review divisions have added a total of 77 new hires and have 105 people waiting in the wings, Veverka said. The center is authorized to have a total of 553 positions, including 62 funded by user fees. CDER began FY 1993 with 470 positions. The agency has stepped up its recruitment and training efforts to handle employee turnover and the hiring needed to add 620 extra positions over the next five years as authorized by the Prescription Drug User Fee Act of 1992. Veverka noted that FDA plans to have 50% of the new "review staff on board by Dec. 31, 1994." PMA-BIO User Fee Task Force Chair Ken Berkowitz noted that as part of its "partnership" with FDA on user fees, industry has set up "mirror committees" of FDA working groups to assist in recruiting and training, project management and information systems. At the exchange meeting, the first in a planned series on the implementation of user fees, CDER Deputy Director for Review Management Murray Lumpkin was asked where the new hires funded by user fees would be assigned. The divisions have been asked "to give us an idea of what they see their workload as being, what they see [as] their needs in order to [meet] performance goals," Lumpkin said. CDER also has "gone back and looked back at what the history has been for NDAs in various divisions." Lumpkin added that "the actual review disciplines that are hired are done primarily on a division-by-division basis." Discussing the management of application reviews under the user fees program, Lumpkin stressed that "tracking is something that is going to be absolutely critical for this." The FDAer pointed out that "accountability" is also a very important part of CDER review management initiatives. "We have a program that we are working on that will inject hopefully a very true sense of accountability all the way down to the primary receiver on time frames, meeting times frames, meeting goals and having the very real understanding that we're very, very serious about this." Lumpkin said FDA's "biggest challenge at the end" is having systems in place to assure that "scientific thoroughness and quality of review" is not compromised by increasing the timeliness of drug reviews. Such assurance will "involve a lot of effort pre- approval and also a significant amount of effort post-approval as we follow the applications." Veverka told the meeting that "achieving improved approval times, as opposed to review times, really is the collaborative responsibility of the sponsor and the reviewer." FDA is "working very closely with industry to develop and oversee a joint program to improve the review time," she noted. Not unexpectedly, implementation of the user fee program will also speed up the timing of pre-approval inspections. "We're doing pre-approvals right now about the seventh month after submission, on the average," FDA Mid-Atlantic Region Assistant Director Joseph Phillips said. "With user fees, I think you will see us...come out there within 45 days of the submission." Phillips advised: "I think when you submit the application you should be ready." Mid-Atlantic Region Director Richard Davis pointed out that "out of the user fee program, about 40 FTEs have already been allocated to the field to conduct...pre-approval inspections under the new program." In July, the agency issued its first round of invoices for annual product, establishment and application fees for applications submitted between Sept. 1, 1992 and April 30. Along with the invoices, companies were given a packet of user fee guidances concerning bundling of applications, waivers and definitions of clinical data ("The Pink Sheet" July 26, p. 3). FDA issued invoices for $29 mil. and so far has received "a little over $26 mil.," FDA Division of Financial Management Director Frank Claunts said. A second round of billing will begin in October, Claunts noted. The invoices will cover fees for applications filed between May 1 and Aug. 31, 1993, for action letters issued after April 30 and for any fees not included in the first billing. CDER Associate Director for Policy Jane Axelrad said the second round of invoices will also include product fees for innovator antibiotics, which were left out of the initial billing. She added that FDA is preparing a letter asking firms to determine if they have innovator antibiotics still listed and on the market. Aexlrad explained that FDA "concluded in the initial vetting process that, unlike other drug products, innovator antibiotics products...remain subject to product fees even after a competing general antibiotic is approved." The user fee statute contains an exception from product fees for other approved drug products "that are the same product as a product approved under an application filed under section 505(b)(2) or 505(j)." FDA Deputy Chief Counsel for Administration Ken Baumgartner was asked whether the agency has any plans to propose changes in the user fee law. "Yes. We are proposing to go back to Congress with some technical amendments and these we view as being truly technical to reflect what was intended at the time the act was originally drafted, but are not covered under present law." "We're looking at the disparity in the treatment of general and pioneer antibiotics," Baumgartner noted. "There's a problem with respect to finished dosage form where the manufacturing process is brought up to all but one step and that step is performed by a different establishment....We're concerned with the whole issue with respect to establishment fees as applies to affiliates." FDA also will address "the issue of shared manufacturing of biologics," Baumgartner said. "We believe that needs to be addressed to provide some relief in that situation." CBER Associate Director for Policy Michael Beatrice said: "The statute says the establishment fee goes to...who makes the final drug product and therefore in a shared arrangement it would be the final product manufacturer." Beatrice noted: "But that doesn't prohibit manufacturers from making arrangements to split the payment among each other."

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