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Executive Summary

Upjohn's Ansaid (flurbiprofen) is one of the first two drugs approved by FDA through an experimental new drug approval mechanism, "NDA Day." The format of the drug review process was outlined by FDA's Center for Drug Evaluation and Research Director Carl Peck, MD, at the Food and Drug Law Institute's 32nd Annual Educational Conference, Nov. 29-30. The intent of the process, Peck said, "is to provide an efficient and compressed tertiary review of the NDA in a way that reduces the overall review time." Developed by Office of Drug Evaluation Director Robert Temple, MD, and Anti-Inflammatory Drugs Group Leader John Harter, MD, "NDA Day" involves an intensive one day interchange between the tertiary reviewer, primary reviewers and the NDA sponsor. Three drugs were considered by the Office of Drug Evaluation I under the "NDA Day" system. Along with Ansaid, Ciba-Geigy's Voltaren (diclofenac sodium) was also evaluated and determined to be approvable, according to the office. A third, unnamed drug was found not to be approvable. FDA sees the use of the "NDA Day" approach to be appropriate in reviewing complicated NDAs, the office noted. The first step in "NDA Day," Peck explained, is for the particular division to put together the NDA package along with the division's recommendation for approval or disapproval. Temple then sets aside an entire day to devote to the review of the NDA. Peck noted that he as well as other senior staff have been invited to join Temple in the "seminar style review." During the review, he said, "various members of the review team present and analyze and discuss and get queried by Dr. Temple on the nature of the data and the decisions that are pending." The NDA sponsor is also invited to FDA to answer any questions that arise during the review. Peck noted that the firm representatives are asked to wait in a separate room from the reviewers. "They're given a telephone line or a computer line to get the facts... to get information back and forth from the company for the purposes of that review for that day." Peck noted that Temple has "a one-week deadline after the `NDA Day' to make his final cut." Commenting on the "NDA Day" scheme, Peck said: "It's really a very exciting experiment that has taught us a great deal... about how we can further compress the review time and we expect to continue this." He noted that FDA probably cannot hold such a review for all of the 230 NDAs currently pending at the agency. "NDA Day" is used exclusively in the Office of Drug Evaluation I. That office includes the following drug review divisions: Cardio-Renal, Neuropharmacological, Oncology & Radiopharmaceutical, Surgical-Dental, and Gastrointestinal & Coagulation. The Office of Drug Evaluation II under James Bilstad, MD, said that it is observing the experimental review process being conducted by its counterpart. Bilstad's office noted that it would consider the "NDA Day" approach should one of its divisions express interest in using it for a particular NDA. Peck mentioned other programs, which the agency is implementing or has established for improving the drug review process. These activities range from the hiring of additional medical reviewers to informing pharmaceutical companies of the importance of conducting early pharmacokinetic and pharmacodynamic studies. The center director pointed to the agency's establishment of a recruitment resource for medical reviewers in the Office of Professional Development, which is headed by Merck research exec William Abrams, MD ("The Pink Sheet" April 11, 1988, T&G-1). Peck stated that he has "insisted on interviewing every medical officer candidate since I've been at the job" and that he insists on agreeing on their hiring. He noted that the agency has established "a stringent performance review strategy" to determine whether medical officers should be kept during the probationary period. FDA has a research training fellowship established with the Uniformed Services University in order to assist in the acquisition of medical officers, Peck noted. The agency expects that program to bring in two new medical officers a year ("The Pink Sheet" March 14, 1988, p. 9). He added that FDA is "working with John Hopkins and Howard and Georgetown in evolving possible programs with them." An agency method for improving NDAs, which Peck views as a personal innovation, is "a call for increased use of pharmacokinetic [and] pharmacodynamic studies early in drug development." He stated that the importance of conducting these studies is that they provide "a powerful method of designing dosing regimens, which have a optimal chance of showing effectiveness with minimal toxicity in the fewest number of subjects in clinical trials." The subject seems to be an ongoing theme in Peck's public presentations ("The Pink Sheet" Nov. 7, 1988, "In Brief").

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