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FDA ANTI-INFLAMMATORY/ANALGESIC DRUG REVIEW DIVISION

Executive Summary

FDA ANTI-INFLAMMATORY/ANALGESIC DRUG REVIEW DIVISION is being established under the acting leadership of John Harter, MD, and the direct oversight of Center for Drug Evaluation and Review Director Carl Peck, MD. The new division, which will also be in charge of anesthetics and drug abuse, is being carved out of existing divisions in the Office of Drug Evaluation I, headed by Robert Temple. The new division is separate from the Office of Drug Evaluation I. Reporting directly to the Office of the Director for the Center for Drug Evaluation and Review, it will bypass the necessity to communicate through Temple's Office. In a March 31 memo to CDER staff, Peck described the new group as a "pilot review division" that will experiment with ways to improve the new drug review system. "It is difficult for someone outside the review process to be credible in proposing changes," Peck explained. "Mindful of this, I will involve myself directly in the management of one component of the process that will serve as one focus for 'pilot testing' innovations in new drug review." Faced with several potential NSAID Rx-to-OTC switch candidates (naproxen, sulindac and diflusinal among others) and a continuing full plate of NSAID Rx NDAs, the new division could be an interesting testing-ground for reform ideas. The NSAID product class has traditionally been a slow approval class at FDA. The cautious review pace slowed further after the side effect experiences with Zomax and Oraflex in 1982-1983. FDA also recently completed a lengthy revision of class labeling for the drugs. One of the more contentious NSAID issues has been Harter's interest in ranking NSAIDs by their safety profiles. Harter is currently in charge of NSAIDs in his post as Anti-Inflammatory Group Leader in the Oncologic and Radiopharmaceutical Drug Products Division. The new division is part of a broader restructuring of the Office of Drug Evaluation I. Under the plan, the Cardio-Renal Drug Products Division, headed by Raymond Lipicky, MD, and the Gastrointestinal and Coagulation Drug Products Division, headed by Stephen Fredd, MD, will remain intact. The Neuropharmacologic Drug Products Division, run by Paul Leber, MD, will be giving up its drug abuse unit and analgesic review functions to the pilot anti-inflammatory/analgesic division. The Oncology/Radiopharmaceutical Division, in addition to losing anti-inflammatories, will no longer review radiopharmaceuticals. The group is being renamed the Oncologic and Pulmonary Drug Products Division and will trade radiopharmaceutical responsibility for pulmonary drugs with the Surgical-Dental Drug Products Division. In line with its new responsibilities, Surgical-Dental is being renamed the Radiopharmaceutical, Surgical and Dental Drug Products Division. The division previously was responsible for anesthetic agents, which will now be reviewed by Harter's division. Greg Burke, MD, will act as director of the realigned Oncologic division, while John Palmer, MD, will act as director of the Surgical-Dental division. Peck's memo to staff emphasizes that the "new division is not intended to be a 'sole site' for experimentation or a privileged community. Continued leadership and innovation in all divisions will be encouraged and supported, and we will all try to learn from one another."
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