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"NDA DAYS" HAVE BEEN HELD BY TWO FDA GROUPS OUTSIDE OF PILOT DRUG EVALUATION STAFF; PILOT GROUP CONVENED SIX "NDA DAYS" IN 1990, MORE PLANNED

Executive Summary

FDA's experimental "NDA Day" format has been used in a modified form outside of the agency's Pilot Drug Evaluation Staff, which pioneered the concept, by the agency's anti-infective division and biopharmaceutics division. Speaking at the Regulatory Affairs Professionals Society's annual meeting Oct. 16, Pilot Drug Evaluation Staff Consumer Safety Officer Mary Owens reported that "two groups outside the Pilot group have also tried the concept" of an NDA Day. "Biopharm Day was reported to be successful," Owens said. She also indicated that, "in another division, a drug was approved using a modified approach to NDA Day." Reportedly, the anti-infective division has experimented with the "NDA Day" concept. FDA's Pilot Drug Review Staff, which reviews analgesics, anti-inflammatories, anesthetics and drug abuse treatments, initiated the NDA Day concept in April 1988 with Ciba-Geigy's nonsteroidal anti-inflammatory Voltaren in an attempt to speed up the final stages of the NDA review process. Since that time, the Pilot Review Staff has conducted 13 NDA "Days": three in 1988, four in 1989, and six so far this year, including one that required additional time and is still in progress. Owens suggested that the program has not been more widely used by other divisions because of the time required by both FDA and drug company staffs. Despite the ability of NDA Days to save "months to a year at the end of the review process," Owens postulated that the reason the NDA Day approach has not become more "popular" is that "it is so labor intensive, being very hard on both the FDA's and sponsor's staffs, particularly with regard to preparation." She noted that while "companies do benefit from the process," they are "exhausted at the end, wondering how we do it repeatedly." Consequently, part of the pilot division's experimentation with the concept, Owens said, has been an effort "to make the process easier for everybody, more efficient and less stressful." At the beginning of 1990, Owens noted, the Pilot Drug Evaluation Staff, together with Center for Drug Evaluation and Research Director Peck and Office of Drug Evaluation I Director Temple, set aside 12 to 14 dates for possible NDA Days through the year. However, by the end of July, the Pilot review staff had held six NDA Days. "Not all of these dates have been utilized," she said, "because of lack of readiness on either the company's or FDA's part." The pilot evaluation division has "several" more NDA Days scheduled before the end of the year. Also speaking at RAPS, Pilot Drug Evaluation Staff Medical Officer Linda Katz, MD, said that "no specific hard and fast criteria" are used in making the determination whether or not an NDA Day will be used for a given NDA, but that "it is usually the NDAs that we think are going to go for approval" that are given an NDA Day. Owens explained that in planning for NDA Days, FDA tries "to identify those projects which should be ready for an NDA Day two to four months ahead of time." At that point, FDA meets with the sponsor to begin project management. "This has helped us to identify what needs to be done, make a schedule, and help us hit the target date," she said. Owens emphasized that the NDA day is "an evolving, experimental idea with room for flexibility. Each session has been a bit different. The design of the day has been determined by the nature of the drug, the needs of the agency, the personnel involved, and the sponsor's suggestions." The Pilot Drug Evaluation Staff is considering improving the process further by "incorporating an earlier review of IND studies at IND Days," which would allow "a quicker and less stressful review of the NDA," Owens reported. The pilot division also is looking at bringing in sponsors "just for the labeling review," Owens told the RAPS group. As the concept of the NDA Day has progressed, Katz noted, "the companies have had more of an involvement and have actually been able to participate in the room to varying degrees." At the most recent NDA Day, held by the Pilot Drug Evaluation Staff on July 30 for fentanyl TTS, Alza became the first industry sponsor to participate "in the actual presentation of the data," Owens said. The company was invited to participate in order to explain a word processing program developed by the firm that allowed participants to keep track of the labeling changes during the discussion. Owens said that Alza representatives also participated "in two preliminary meetings on pharmakinetics-pharmacodynamics modeling of the system two work days before NDA Day in order to help some of those outside of the Pilot Drug Evaluation Staff prepare." Fentanyl TTS was approved just one week after the meeting ("The Pink Sheet" Aug. 13, 1990). FDA is currently in the midst of another NDA "Day" that Owens said "has been aptly named NDA Day Month." She noted that "because of the large size of the NDA, and a need to work through some of our differences of opinion, this NDA Day has turned into a series of meetings over September and October." Of the six NDA Days this year, three have been "mini-NDA Days," Owens said. At a March 30 mini-NDA Day, FDA discussed the first supplements brought to the NDA process for dysmenorrhea and heavy menstrual blood flow for Warner-Lambert's Meclomen as well as "areas of general interest to our division" and other reviewing divisions, she noted. Owens said that the Pharmaceutical Manufacturers Association "helped to coordinate the initial arrangements" of this meeting. On April 16 and July 9, the division held two other mini-NDA Days to discuss "items of general interest/broad concerns, a newly received innovative IND, demonstration of equipment and to finish up the Meclomen labeling and pharmakinetics section of the package insert." The April 16 mini-NDA Day, Owens said, "was affectionately and unofficially known as 'OTC Day' -- to be more precise 'over the counter' and 'on the corner.' At that meeting, the division discussed issues common to several sponsors seeking to have their NSAID reclassified as OTC.
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