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GENETIC SYSTEMS' COMMERCIALIZATION OF UNAPPROVED IN VITRO DIAGNOSTICS

This article was originally published in The Gray Sheet

Executive Summary

GENETIC SYSTEMS' COMMERCIALIZATION OF UNAPPROVED IN VITRO DIAGNOSTICS is cited by FDA in a June 22 warning letter to the firm's parent, Sanofi Diagnostics Pasteur, Inc. In a recent inspection of the company's Seattle, Washington operations, FDA found that the company "failed to exercise due diligence to assure that unlicensed biological products shipped for investigational use" would be used according to regulations governing investigational in vitro tests. For example, FDA asserts that the firm's page blot HIV-1 Western Blot test kit is being "shipped in interstate commerce without an approved product license application or an IND [investigational new drug application] permitting such shipments." The test kits, "labeled 'for research use only,' have been shipped to various firms with the apparent purpose of promoting this product for commercial use," FDA adds. The agency also says that the firm's strip format HIV-1 Western Blot, HIV-2 Western Blot, and HIV-1/HIV-2 test kits, for which INDs are in effect, are being "shipped to accounts not authorized within the scope of the IND and for which there is no assurance from the consignees that the products will be used for research use only." The company responded to the warning letter on July 2. The firm intends to "comply with all FDA regulations," according to a spokesperson. Interstate shipment of saliva collection devices, "intended for the collection of samples for use in the saliva feasibility study," was also cited by FDA as violating federal law. An investigational device exemption (IDE), as required by statute, "has not been submitted, nor has a product license amendment been approved to permit shipment of the devices for use" with the company's test kits, FDA says. The warning letter adds that Genetic Systems' HLA-B27 antigen typing kit is being used for off-label uses. The kit, which is "approved for use with fluorescence microscopy, has been shipped to accounts who have used it in conjunction with flow cytometry, an unlabeled use." FDA points out that it has not received any "premarket notification or information regarding the use of the device with flow cytometry" from the company, as required to support use for a new indication. FDA notes that "on several occasions in the past," the agency has notified the company when it became aware of the use of anti-HIV-1 test kits "in a manner not consistent with your approved labeling." The agency reminds the company that as the manufacturer of biologics and IVDs "subject to misuse, you are expected to use due diligence to assure that consignees are not using the products at variance with approved directions for use." Continued distribution of test kits to "consignees whom you know or suspect are using the products in a manner inconsistent with your approved labeling is a violation of the" Food Drug & Cosmetic Act, FDA concludes.

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