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This article was originally published in The Gray Sheet

Executive Summary

LABORATORY "IN-HOUSE" IVDs: FDA AND HCFA MEETING AUG. 2 to discuss possible joint regulation of the products, according to FDA. FDA and the Health Care Financing Administration have agreed to develop a memorandum of understanding for the joint regulation of in- house in vitro diagnostics. Under the agreement, HCFA would assist FDA in enforcing its policy on unapproved IVDs by auditing labs for compliance with the "home brew" provisions of the policy during inspections conducted under the Clinical Laboratory Improvement Amendments of 1988. At the Aug. 2 meeting, FDA and HCFA will seek to define the scope of each agency's jurisdiction under the MOU. FDA released a revised version of its compliance policy on unapproved IVDs in October 1992 ("The Gray Sheet" Oct. 26, 1992, p. 3). Developed primarily to restrict manufacturers' commercialization of unapproved tests, the policy also says that FDA will regulate "home brew" tests that clinical laboratories develop or modify for in-house use. The American Association of Clinical Chemistry (AACC) and the College of American Pathologists (CAP), which have opposed FDA regulation of laboratory tests, floated the concept of an FDA/HCFA agreement in discussions with FDA earlier this year. Under the clinical lab groups' proposal, FDA's jurisdiction over in-house tests would be scaled back from earlier agency proposals. The form that the FDA/HCFA pact ultimately will take, however, remains unclear. The associations suggested that most in-house tests should be regulated only by HCFA under CLIA, according to AACC staffers. FDA would take action in cases of egregious violation of the agency's IVD policy, such as laboratory promotion of unapproved in-house IVDs. This type of program, AACC staffers argue, would eliminate duplicative regulation of laboratories under CLIA and the Food, Drug & Cosmetic Act while ensuring the quality of laboratory tests. The Washington, D.C. law firm of Hyman, Phelps & McNamara made similar arguments in an October 1992 petition to FDA ("The Gray Sheet" Nov. 2, 1992, p. 3). Regulation of labs' in-house tests has emerged as one of the more contentious issues regarding FDA's draft policy on unapproved IVDs. FDA announced its intention to regulate clinical labs' in-house products in August 1992 ("The Gray Sheet" Aug. 3, 1992, p. 1). In the most recent draft of the policy FDA says it will consider the "public health significance of the disease or condition" diagnosed by a lab's test and the "significance of the test results to the individual" when taking enforcement actions. In a November 1992 letter to FDA, however, eight clinical laboratory groups, including the AACC and the CAP, said the revised draft did "not alleviate the concerns" of the lab community ("The Gray Sheet" Dec. 7, 1992, p. 4). The groups feel that the policy would subject labs to dual regulation by HCFA and FDA and would eliminate access to "hundreds" of tests. Finalization of the IVD policy has been delayed by controversies such as the one surrounding in-house tests. The policy's "accommodation list," under which manufacturer's tests that have become the standard of care would be exempted from the policy for 30 months, also has proven problematic and may be changed in the final document ("The Gray Sheet" Nov. 23, 1992, p. 5).

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