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Executive Summary

FDA ELDERLY CLINICAL TESTING GUIDES: SENATE AGING COMMITTEE joins its House counterpart (the Aging/Human Services Subcommittee) in pressing FDA to complete the pending guidelines. In an April 24 letter to FDA Commissioner Young, the Senate asked for a followup to its previous inquiries about the progress of the guidelines. The Senate committee looked into the status of the guidelines over one year ago, at which time FDA promised they would be out in August 1988. In light of the impending Medicare prescription drugs coverage, the committee said, it is particularly anxious to see the implementation of the guidelines and of the agency's pending geriatric labeling reg. Signed by committee Chairman Pryor (D-Ark.) and Ranking Minority Member Heinz (R-Pa.), the letter requests detailed information on the status of the guidelines as well as on the progress of the agency's geriatric labeling regulations. Heinz chaired the committee in 1983, when FDA originally proposed the guidelines. The letter follows a statement by FDA Commissioner Young to the House Aging/Human Services Subcommittee hearing April 19 that the guidelines may not be issued for another six months to one year ("The Pink Sheet" April 24, p. 7). FDA's geriatric label regulations are under review in the agency general counsel's office, Commissioner Young told the House subcommittee. The reg would require that information related to use of drugs in the elderly be placed in a special section in professional drug labeling. The Senate committee expressed an interest in FDA data on the participation of the elderly in studies done for pending or recently approved NDAs. The agency is in the process of collecting such data for NDAs approved in 1988. The committee asked FDA to submit the requested information by May 22.

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