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Executive Summary

GERIATRIC USE INFORMATION WOULD BE REQUIRED IN DRUG LABELING under an FDA proposed rule published in the Nov. 1 Federal Register. The agency is proposing to require a new subsection in prescription drug labeling that would either describe available information on geriatric use of the drug or note that such information is currently unavailable. FDA explained that the proposal "reflects growing recognition by FDA, Congress and others of the special concerns associated with prescription drug use in the elderly." Patients over 65 currently consume over 30% of prescription drug products in the U.S. and approximately 40% of nonprescription drugs, while representing only about 12% of the population, FDA pointed out. In addition, elderly patients may respond differently to many prescription drugs than younger patients. Under the proposal, drug companies marketing a prescription product would be required to collect and disclose "all information" in their possession "that is relevant to an evaluation of the appropriate geriatric use of the drug." The information could include results from controlled studies, other pertinent premarketing or postmarketing studies, adverse reaction report experience, or information obtainable from the literature. This information would be placed in a separate section of "Precautions" entitled "Geriatric Use," with references to applicable detailed discussions in other parts of the labeling, FDA explained. The agency emphasized, however, that information "about specific geriatric indications, e.g., 'senile dementia,' would not be appropriately placed in the proposed 'Geriatric Use' section," but would instead appear in the "Indications" section of labeling. "The proposed subsection would contain several kinds of statements about drug use in the elderly reflecting increasing amounts of available information," the notice states. "If clinical studies did not include sufficient numbers of elderly subjects to permit a determination whether elderly subjects responded differently than younger subjects...the labeling would declare that no distinction between elderly subjects and younger subjects could be made," FDA noted. "The dosing would further advise that dosing for older patients should be cautious reflecting the greater frequency of concomitant disease and drug therapy and decreased hepatic, renal, and cardiac function in elderly patients." If clinical studies did include sufficient numbers of elderly patients, but no significant differences were seen, FDA continued, the proposal would require disclosure of the number or percentage of elderly subjects in the study, and would require the labeling to note that "grater sensitivity in some older individuals cannot be ruled out" although no differences in overall safety or efficacy were seen. And, if differences in safety or efficacy are seen in studies, drug sponsors would be required to disclose such differences in the appropriate sections of the labeling. The agency also pointed out that the proposal "is not intended to require additional clinical studies." However, FDA noted that it still encourages further study of drug effects in the elderly. A final rule on the geriatric-use labeling change would become effective one year after its publication in the Federal Register. After this date, drugs will be considered misbranded if their labeling is not in compliance with the rule. FDA noted that "50% of existing prescription drug labeling contains some geriatric use information." ANDA holders will be required to adopt the same labeling as the pioneer product within four months after FDA has approved the label change for the pioneer product. The proposal for a "Geriatric Use" subsection in drug labeling is the second regulatory reform undertaken by FDA this year that relates directly to drug use by the elderly. In March, the agency issued a guideline for clinical study of drugs used by the elderly ("The Pink Sheet" March 12, p. 5). The seven-year development period for the guideline on drug testing in the elderly drew the attention of both the House Aging/Human Services Subcommittee and the Senate Aging Committee last year. At an April 1989 hearing on drug misuse in the elderly before the House subcommittee, then-FDA Commissioner Young was asked about the delay in issuing the guideline. At the same hearing, Young noted that FDA was working on a regulation requiring that information on use of drugs in the elderly be placed in prescription drug labeling.



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