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Bill Would Provide Safe Harbor for Makers of IVD 'Research Use Only' Tests

NEW YORK (GenomeWeb News) – A bipartisan bill has been introduced in the US House of Representatives that would provide a safe harbor for in vitro diagnostic test makers if their tests that are approved for research use only (RUO) are used by their customers in certain clinical settings.

The proposal would protect test companies, and other manufacturers of RUO products such as probes, primers, and instruments, from the possibility that they might be liable for how their products are used inappropriately by customers, a concern that arose from a Food and Drug Administration draft guidance on RUOs published in 2011.

That document was supposed to clarify what types of tests are labeled for RUO and for investigational use only, products which FDA said are "distinctive" because they may eventually be cleared for use as clinical diagnostics and because they may be marketed and used in studies of other FDA-regulated products.

The FDA document detailed some terms of how RUOs should be marketed, and noted that test makers cannot sell or provide technical support to labs that are using these products for clinical diagnosis or in clinical investigations. Under the guidance, if a test maker discovers that it is selling to a lab that is using its RUO-labeled IVD for clinical diagnostic purposes, then the manufacturer is expected to halt sales to that lab.

The Medical Testing Availability Act of 2013 (H.R. 3005), introduced earlier this month by Mike Burgess (R – Texas) and Jackie Speier (D – Calif.), aims to protect IVD test makers by stating that the RUO label for its tests will still hold even if it sells to an end user who is using the test in ways that are not consistent with that labeling, i.e. clinical diagnosis.

The bill also would enable the test maker to engage in a range of business communications, including technical support, customer service, and other related communications, with the end user.

Biotechnology Industry Organization President and CEO Jim Greenwood said in a recent statement that BIO supports the bill because the FDA guidance would expand the definition of 'intended use' to cover "downstream use of the product outside of a manufacturer's control," and that the guidance was legally without precedent and would mark a shift in FDA's approach to regulating how products are promoted.

"By creating a safe harbor for these targeted, ordinary business practices, the bill allows for continued use of and access to research use only products," said Greenwood. "BIO appreciates that the bill is narrowly tailored to address only those commonplace practices that FDA claims would constitute a 'reason to know' that a product is being used in a clinical diagnostic application under its newly promulgated standard.

The bill has been sent to the House Energy and Science Committee.