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FDA PUBLICATION OF GERIATRIC TESTING GUIDELINES

Executive Summary

FDA PUBLICATION OF GERIATRIC TESTING GUIDELINES would be "strongly" urged by Congress under congressional "options" developed by Senate Special Committee on Aging Chairman Melcher (D-Mont.). At a March 25 hearing, the senator announced five options for Congress related to the issue of adverse drug reactions experienced by elderly patients, for whom Melcher said prescription drugs are often misprescribed or over prescribed. One option involves "strongly encouraging the FDA to publish its long-awaited guidelines for clinical testing of new drugs in the elderly." The guidelines, Melcher noted, "would require drug manufacturers to determine if a new drug is more likely to elicit an adverse reaction from an elderly person. These guidelines have been in draft form since 1983." The agency may be facing increasing pressure to produce the final guidelines. Melcher pointed out that a March 22-23 Workshop on Health Promotion and Aging within the Surgeon General's Office recommended that "FDA should proceed" with publication of the final guidelines. Sen. Heinz (R-Pa.), who chaired the committee in 1983 when FDA published its draft guides, criticized the agency's delay and its refusal to testify at the hearing. Heinz maintained that FDA did not appear because it did not want to explain why its final guidelines for drug clinical testing in geriatric patients were not issued through a proposal was published in 1983. Heinz suggested that publication of final guidelines has been delayed because they "would require the pharmaceutical manufacturers to do additional work . . . to have a subsample of the elderly" tested for each new drug. Noting that 300,000 elderly Americans are hospitalized annually due to adverse drug reactions, Heinz added the hearing was "very timely" insofar as "Congress is on the verge of enacting a national prescription drug benefit program under Medicare." Another Melcher option would be to assure that FDA considers the need for more information on geriatric drug use and effects in its procedures for approving and updating drug labeling. Under another option, Congress would review "FDA policies for approving and updating the drug labels, which advise physicians and other health care providers on proper drug prescribing use." The senator said a review is needed "because most of these labels contain specific information and warnings for children and pregnancy, but not for the elderly." Melcher also suggested funding studies on how to educate physicians "who appear to be inappropriately and/or excessively prescribing medications that are known to pose particular dangers to the elderly. Melcher said additional options include support for programs to encourage greater geriatric training in medical schools and for studies on drugs that are widely used in the elderly but for which information on potential ADRs in unavailable.

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