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PRE-APPROVAL INSPECTIONS MAY BE WAIVED FOR FIRMS WITH STRONG RECORDS; NDA/ANDA REQUIREMENTS TO CHANGE AS DELEGATION TO FIELD INCREASES, REGIONAL FDAer SAYS

Executive Summary

Pre-approval inspections may be waived for firms with strong records in previous audits under one of several FDA initiatives now being pursued to "streamline" the review process Mid-Atlantic Assistant Regional Director Joseph Phillips said May 25 in Valley Forge, Penn. Phillips discussed the proposed changes to the pre-approval inspection program, which he said are nearing implementation, at an update on the program sponsored by the Central Atlantic States Association of Food and Drug Officials. "If a firm has a 100% success rate and they've submitte...let's say...five applications, and they've had a total success rate, is it really necessary that we go out on a sixth application?" Phillips asked. "Maybe it's time to consider backing off in the selection of firms for coverage," Phillips suggested. "Maybe we can consider approving based on past performance -- past demonstrated, documented performance. We always have the option to come out [later] and inspect." Another element of the initiative calls for firms with a history of pre-approval inspection turndowns to be contacted by FDA through a letter inviting the company's top executive officer to "come in...and discuss what it is we can do to help you improve your operations, so that you can improve your success rate," Phillips said. "Now trust me, when we start sending letters to the top executive officers . . I think that's going to get their attention. They want products approved through the system." The plan to contact firms with low success rates comes in response to growing frustration among industry officials and FDAers with a turndown rate that has hovered near 40% for the past two years, after a 21% drop following the program's first year ("The Pink Sheet" April 12, T&G-13). "It's about time we try something new," Phillips said. The Mid-Atlantic Region has begun compiling data on firms' pre-approval inspection records to determine which firms may be allowed to forego pre-approvals and which will be targeted for assistance. "Individually, I can deal with you," Phillips told industry officials. "W can communicate, we can get together and maybe we can fix things and make it better. The name of the game is to get good science through the system as quickly as we can...We're going to help you do that." Phillips noted that field management "will be talking in two weeks with th drug committee of the Center [for Drug Evaluation and Research] on these initiatives" in the hopes of implementing them nationally as quickly as possible. In a related initiative, Phillips announced that certain elements will no longer be required in NDAs and ANDAs but will be handled instead by field staff during pre-approva inspections. CDER is drafting a letter "to alert the industry to the impact of this change," Phillips said. The items that will no longer be required in an application include raw material controls; laboratory controls; facilities; personnel; equipment qualification; packaging validation; and ancillary facilities. "This is going to be a big change, a significant change," Phillips predicted. "I can't give you a timetable, but it's imminent," he added. The policy increasing field responsibility originated with a team assemble by FDA Commissioner Kessler in September 1991 to develop a model program to "strengthen and streamline" FDA review processes and "identify and eliminate redundancies." The team was composed of FDA Office o Generic Drugs Director Roger Williams, Senior Advisor to the Commissioner for Management and Systems Mary Jo Veverka and Mid-Atlantic Regional Food and Drug Director Richard Davis. "The initial thrust was, let's just have the field review those elements," Phillips said. "In discussing this further, they designated a group to write implementation language on ho we were going to accomplish this task. The upshot [was] we reached agreement that these elements would no longer be required in an application." "Now be careful of that," Phillips warned industry officials attending the meeting. "It doesn't mean it is of no importance. What it means is, it will be handled during the pre-approval inspection by field staff, just like it is now, but...the detail will not be required for an NDA or ANDA." Phillips also urged industry execs to "begin to gear up" for submitting a third copy of the chemistry and manufacturing section of NDAs or ANDAs to the field office. A regulation on third-copy submissions was initially proposed in the Jan. 28, 1991 Federal Register and is currently in the Office of Management and Budget. "It remains my sense that the final regulation will issue requiring you to submit the third copy ...because many of you want it and we at the agency want it," Phillips predicted. FDA has been encouraging firms to voluntarily submit third copies of the chemistry and manufacturing section. In another move affecting the pre-approval process, the Mid- Atlantic Regio has revised its guidance for inspection of laboratories in response to the Newar federal court's February 1993 ruling in U.S. v. Barr (see related item, T&G-). The revised edition is currently being reviewed by headquarters and contains "a number of items that were contained in the decision," Regional Director Davis announced. He said he hopes the national guidance will be released by the end of June. At the May 25 meeting, the Mid-Atlantic Region released a recently revised draft of an inspection guide on cleaning validation that also references the Barr decision. Th inspection guide "is designed to establish inspection consistency and uniformity" in evaluating the validation of cleaning processes, the document states. (see related item, T&G-??). Another Mid-Atlantic Region draft guide, addressing the inspection of topical products, was released at the meeting. Pre-approval inspections could eventually occur as soon as 45 days after a application is filed as the agency gears up to meet goals set by the Prescription Drug User Fee Act, FDAers at the conference predicted. "If this agency is going to be approving applications within six months from the time that it hits our door ...that puts a lot of pressure on the field to get that pre- inspection completed," Davis said. Phillips urged industry execs to "bear in mind that these applications may generate inspections much quicker." He noted that firms often count on the lag-time between acceptance of an application for filing and pre-approval inspection to get their operations in order. FDA's Veverka, who chairs the User Fee Steering Committee, said the pace o the review process already has begun to quicken since the passage of the statute in October 1992. She stressed the importance of high-quality submissions in speeding up the process. "One observation that I've often heard within [CDER] is that industry often submits 'wine before its time,'" Veverka quipped. "Industry has to change their target from submission date to approval date, because I fully believe that one of the reasons we have been getting immature submissions is because the measurement target on your part is the submission date," she told conference attendees.

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