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ORPHAN DRUG DUE PROCESS PROCEDURES ARE IMPORTANT

Executive Summary

ORPHAN DRUG DUE PROCESS PROCEDURES ARE IMPORTANT to protect the holders of exclusivity positions, Amgen maintained in recent comments on FDA's proposed orphan drug regulations to implement section two of the Orphan Drug Act. "The rule's failure to afford innovators notice of, and opportunity to respond to, assertions that a competitor product is a purportedly 'different' orphan drug is a serious Constitutional deficiency," Amgen contended. In a Jan. 29 Federal Register notice on the proposed regs, FDA said that it had considered an administrative procedure whereby the innovator of an orphan drug would be notified of the proposed approval of another drug considered by FDA to be "different" from the innovator product. However, the agency decided against the idea in favor of a post-decision judicial review because it concluded that a pre-decision challenge procedure would be time- consuming and could delay approval of the competing drug. Amgen argued that orphan exclusivity is a property right and cannot be withdrawn without due process. The company particularly opposes the agency's discretion to determine that a drug is different from another drug by clinical superiority without comment by the first sponsor. "An innovator company should be given an opportunity to critique and comment upon the way the competitor performed tests to compare the two drugs and the conclusions that the competitor draws from its research." The innovator should also be allowed to conduct and submit studies to disprove any claimed superiority, Amgen maintained. Other groups supporting the due process arguments include Genentech, Allergan, the Industrial Biotechnology Association, and Fujisawa-Lyphomed. Fujisawa-Lyphomed, like Amgen, faces potential challenges to its orphan exclusivity. AIDS activists have called for immediate approval of Fisons' aerosolized pentamidine (Pneumopent) which is being blocked by Lyphomed's Nebupent exclusivity ("The Pink Sheet" April 8, T&G-6). In recent comments on the proposed orphan regs, Fujisawa- Lyphomed said that it is "troubled" by the criterion that would allow a second drug to be approved if it made "a major contribution to patient care." The company said that it is concerned that this criterion "will be amorphous enough to allow what may be essentially political decisions and non-medical non- scientific perceptions to break Orphan Drug Act exclusivity." Fujisawa-Lyphomed maintained that the situation with Fisons is a case in point of how the provision could be abused. The firm pointed out that Fisons claims its product would allow unsupervised home administration of pentamidine, which the company maintained is in "the category of 'minor conveniences.'" Fujisawa- Lyphomed also asserted that the Fisons' claim is "spurious" because experts advise that "administration of aerosolized pentamidine for prophylaxis purposes should always be supervised."
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