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Executive Summary

FDA is "seriously reviewing" the creation of an OTC drugs advisory committee once the OTC drug review is completed, FDA Commissioner Young told the FDA/Proprietary Association conference on self-medication in Bethesda, Md. on Feb. 8. "As we see the light at the end of the tunnel in terms of completing the OTC Review, we must begin to plan for the future," Young said. "We are seriously reviewing the suggestion of instituting an OTC advisory committee to see if and how it might prove beneficial to all parties concerned." Young's remarks at the P-A meeting and similar comments made by him at the Food and Drug Law Institute's December educational conference seem to indicate growing support for the idea at the commissioner level. A chief advocate for establishment of an OTC drug advisory committee over the past year has been FDA OTC Drug Division Director William Gilbertson, who has lobbied the commissioner for such a committee. Gilbertson has said that the primary hurdle for the creation of a committee is funding. Citing P-A's arguments for the creation of a standing OTC advisory committee, Young noted that such a committee could have positive effects in four areas: "enhanced consensus development; preservation and continuity in the monograph system; assurance of an OTC perspective in deliberations on OTC issues; and assistance in managing FDA's scarce drug review resources." In other comments to the P-A conference, Young reported that the agency is preparing to publish revised draft guidelines on the marketing and labeling of OTC in vitro diagnostic tests for home use. The latest draft guidelines include changes from an earlier draft, released last year ("The Pink Sheet" July 6, T&G-5). Young pointed out that the "Points to Consider" document outlines the agency's views on "labeling [such as] visually highlighted directions; explanation of how a test works; medical benefits and test limitations; description of foods or other substances that would affect test results; and interpretation of results and followup action required." This latest version of FDA's draft "Points to Consider" on labeling and premarket submissions for home-use in vitro diagnostics includes only one major difference from the earlier draft. Besides addressing home use testing kits, the new draft adds home-use mail-in specimen collection kits. The only change in the draft guidelines relating to mail-in kits is in the document's risk/benefit considerations section. In noting the differences between home use diagnostics and clinical labomailing it to a clinical laboratory generally lacks the technical training of persons who traditionally have collected or supervised the collection of body specimens, and supervised the transport of the specimens to the test laboratory." The guidelines indicate that FDA's primary concern with mail-in kits is the potential for delay between the consumer's conducting the test at home and the clinical lab's analysis of the test results. The guideline notes that a consumer using a test kit "may not ensure that the specimen that arrives at the clinical laboratory is in the same condition as it was when it was collected (e.g. ensuring that the analyte to be measured does not degrade because of a passage of a long period of time from specimen collection until analysis, or ensuring that a specimen is not exposed to extremes of hot or cold temperatures or other environmental hazards that may affect the test results)." Asked for examples of future home-use tests that may become available, Young noted OTC tests that allow patients to self-monitor drug therapy. "Now I think we're going to see a large number of monoclonal antibodies able to be used and adopted to diagnostic tests. I would predict these would be used in the monitoring of blood levels of various types of therapeutic chemicals . . . [via] excretion in the urine," he said. "None of these will immediately, in my opinion, substitute for the physician's judgment, but . . . with the increased reliance on self-help, there will be a growing need to help the consumer to separate when [there's a] need for absolute professional help" and when there isn't. "I think we're going to see those laboratory tests come into the OTC arena with quite a rapid speed, and we're certainly looking to be prepared for that," Young said.

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