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GEN: FDA & Office Lab TestsFrom: art fougner, md (evsono@pipeline.com)Wed Aug 16 11:10:41 2000
This from today's Reuters Health News and Physicians OnLine - FDA revised criteria could pave way for more physician's office, home care tests By Laura Gilcrest WASHINGTON, Aug 16 (Reuters Health) - The US Food and Drug Administration (FDA) is working to develop criteria that will put more high-tech, "rapid tests" into the hands of physicians, and in some cases, the patient, while assuring that test accuracy remains high, according to FDA officials participating in a workshop this week. The workshop, which was held on Monday and Tuesday, was set up to discuss the criteria used to determine which tests are waived from certain requirements of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. According to current regulations, if a diagnostic product is designated a simple and highly accurate tool, the test is granted waiver status, meaning laboratories can perform the test without having to meet the standards set out in the CLIA. Granting CLIA waivers to diagnostic tests has important implications in terms of improving the overall quality of healthcare, while holding down its costs, according to officials. For example, making rapid tests for diagnosing influenza, or monitoring blood glucose or cholesterol levels available in the point-of-care setting allows immediate feedback of test results to the patient. In addition, experts believe that it improves patient compliance with prescribed therapies and eliminates the higher costs and lag time in getting results associated with commercial laboratory testing. But while proponents of a liberal waiver policy argue that better healthcare and the patients' best interests are on their side, others urge a more cautious approach to granting waivers. Some experts have urged disallowing waivers for tests with a wider margin for error, such as multi-analyte tests, or those that yield results on which entire therapeutic decisions by the physician rest. While the FDA is new to the process of granting waivers to new and already-marketed diagnostics, having taken over the job from the US Centers for Disease Control and Prevention in January, many in industry are hopeful that the FDA will take a more flexible approach in granting them. "[The FDA] may be more reasonable, " Tom Worthy of Cholestech Corporation, a manufacturer of rapid cholesterol tests, told Reuters Health. Indeed, that optimism appears representative of the diagnostic test industry as a whole, regarding the FDA's oversight of waived tests. "We hope this is the beginning of a process [of granting waivers] that more reasonably reflects the congressional intent of CLIA," noted Fred Lasky, spokesman for the Advanced Medical Technology Association (AdvaMed), formerly the Health Industry Manufacturers Association (HIMA). Addressing FDA officials at the public workshop, Lasky criticized the recent practice of requiring use of an internationally recognized reference method to obtain a waiver as contrary to lawmakers' intent. He also noted that Congress did not envision that tests be "perfect" to get waivers, only that they have "low error rates." Lasky said that the only criteria that should govern the process is whether a test maintains the same level of accuracy whether it is performed by a trained or an untrained user. Other industry representatives urged the FDA to merge the 510(k) clearance process and the CLIA wavier process into a single transaction. While regulators, industry, and laboratories agree that point-of-care, rapid tests to diagnose numerous medical conditions is here to stay, some maintain that the CDC went too far in granting waivers for certain tests and that FDA should tighten the criteria for waived tests. HCFA representative Fran Lehr argued that ertain "critical" tests such as the prothrombin time test and blood glucose monitoring tests, already approved as waived tests, should never have been granted such status. "The oversight [needed for such tests] is more than what a waiver provides," she said. HCFA's more guarded approach to granting waivers arose from results of a study conducted by the agency in Ohio and Colorado, which showed incorrect use of waived tests in physician office laboratories (POLs) in 74% of the Ohio laboratories and 33% of the Colorado laboratories. Others were critical of the FDA's automatic waiver of tests approved for home use, a practice added to the waiver process by the FDA Modernization Act. The agency should apply the waiver criteria of simplicity and accuracy to all diagnostic tests regardless of whether they are cleared for home use, Jo Anne Glisson, spokesperson for the American Clinical Laboratory Association, told agency officials. art
-- art fougner, md
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