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Executive Summary

FDA's long-awaited guidelines for clinical testing in the geriatric population will soon reach the commissioner's office for final review before being issued in the next six to 12 months, FDA Commissioner Young told a House Aging/Human Services Subcommittee hearing on drug misuse in the elderly April 19. Asked by subcommittee Chairman Downey (D-N.Y.) when the guidelines would be published, Young replied that Office of Drug Evaluation I Director Robert Temple, MD, "has been working very vigorously, and [the guidelines], he assures me, are leaving his office and coming up to my office." He explained: "In that sort of a tracking system, we're probably looking at, I would say . . . six months at the minimum to a year on the outside" before they are issued. The hearing focused on an upcoming HHS Inspector General's report, which recommends the prompt issuance of the FDA guidelines as one way to help avoid "mismedication" problems among the elderly. At a Congressional hearing about one year ago, the agency had predicted the guidelines would be issued in about three months. The guidelines have been in development since 1983. Temple, who apeared at the hearing with Young, said that "the draft has been circulated to a few people yesterday, actually, and I think we'll probably have it out in a few months." FDA had been forewarned by the subcommittee to be prepared to estimate the publication date for the guidelines. The subject of the hearing was drug misuse in the elderly. The guidelines will recommend that elderly participants be included in studies on any new drug that will probably be used by older patients. The guidelines will also include a recommendation that investigators use a pharmacokinetic screening process in Phase III trials to assess what effect certain drugs have on elderly patients compared to younger patients in the same study. The pharmacokinetic screen was proposed by FDA as a "simple, relatively inexpensive means of finding important, unanticipated, inter-individual differences" in studies, Young explained. He added that while the procedure initially met opposition from industry and academia, a committee of the American Society for Clinical Pharmacology and Therapeutics recently "endorsed the proposal as a reasonable (but not necessarily the only) component of the pharmacokinetic evaluation of new drugs." At least one subcommittee member, Rep. Snowe (R-Maine) expressed frustration over the delay in issuing the guidelines and pressed Young for a firm estimate on the publication date. In response, he said: "the guidelines will be formally published . . . and I expect it will be soon, but I can't predict exactly when because I don't want to be misleading." Young emphasized that "there will probably be a very small change" in the way companies test drugs once the guidelines are published because the industry "already" is including the elderly in studies. Temple added that "it's worth reminding people that the idea that drugs are studied in healthy young people and given to old, sick people hasn't been true for a long time -- if indeed it ever was." Even in 1983, studies had a substantial amount of data on patients over 60, he pointed out. FDA is conducting a survey of studies done on new chemical entities approved in 1988 to assess what percentage of studies included elderly patients, Temple noted. FDA has "some" data on 15 of the 20 drugs approved in 1988, he said. For three of the approvals, "there won't be very much because they were orphan drugs." But, he added, "I have information on 11 of the drugs that were approved and . . . there is extensive use in all of them of of poulation that include elderly." Temple said that the "lowest percentage" of elderly used in a drug's clinical studies "was 18%, and that was over 400 patients." He explained that "most of them run about 30% of populations of over 60" years of age in studies. "A fair fraction is also over 70 [years old], but you don't find a great many people over 80," he noted. Of the eight "general use" drugs approved, Temple said, seven had "specific pharmacokinetic studies done in older populations, six of them had formal studies on the effect of kidney disease [from the action of the drug], six had a formal analysis of either side effects or effectiveness by age, as we requested in the guideline, and four of the eight had pharmacokinetic studies looking at the effect of hepatic disease. So there is very substantial response to the discussion paper of 1983." Discussing other agency actions, Young noted that the agency is working on a regulation requiring "that information related to use of drugs in the elderly be placed in a special section in [professional] drug labeling." A draft of that regulation is under review in the FDA general counsel's office, he said. The section of labeling on geriatric use, which will be similar to the one for pediatric use, "will describe available information or indicate that data on the elderly are not available," Young explained. "We will also ask that the pharmacokinetic data in current labeling be updated," he said. An internal FDA survey "indicates that 212 of the 425 individual drugs used most often by the elderly (50%) contain geriatric information and that 10 of the top 24 (42%) used in the elderly already contain such information," Young told the subcommittee. He also pointed out that the agency's percentages are "considerably higher" than those cited in the HHS inspector general's report, and noted that "the differences may be due to the fact that the FDA survey is more specifically targeted toward the drugs the elderly are actually taking, while the Inspector General's report includes the popular top 200 drugs for all age groups." Young maintained that "there is little scientifc evidence that the elderly have, as a general matter, more reactions than other individuals when the number of medications used is taken into account." Although "the Inspector General's report tentatively arrived at a different conclusion," Young said "we have provided comments to the Inspector General expressing our concern about some of the evidence presented to support this finding, and we look forward to seeing this issue resolved in the development of the final report."

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