Diagnostics companies say recent draft guidance on research-use and investigational tests oversteps FDA’s authorities by asking firms to police how customers ultimately use these products.

In draft guidance issued June 1, FDA said diagnostics firms can be held responsible for inappropriate clinical use of tests labeled for research-use or investigational-use only if they know, or should have known, about it. (See “ Also see "Makers Of Research-Only Tests Must Respond To Inappropriate Use – FDA Draft Guidance" - Medtech Insight, 6 June, 2011. ” – “The Gray Sheet” June 6, 2011.)

That’s a departure from the agency’s typical practice of holding companies responsible for how a product is labeled and marketed, rather than how it is used.

Device trade group AdvaMed and diagnostics makers agreed that firms should ensure that labeling, advertising and promotional materials comply with the law and avoid making clinical claims.

Firms should not be placed in the “untenable position” of policing how customers are using products, device makers say.

“We take the restrictions on commercialization of RUOs and IUOs very seriously,” Roche Diagnostics wrote in Aug. 30 comments.

But firms should not be placed in the “untenable position” of policing how their customers are using the products down the line, AdvaMed said.

Diagnostics maker Thermo Fisher Scientific noted that manufacturers often sell RUO products to large facilities such as research laboratories, teaching hospitals and government institutions, where many researchers use the products. It would be costly and impractical to develop surveillance systems to monitor each researcher’s use of the products, several firms noted.

The guidance could also stifle dialogue between industry and labs, they said.

“If manufacturers are put in a position in which knowledge of use forces them to cease sales, neither manufacturers nor laboratories will desire the type of open relationship and information exchange that generates innovation,” Roche wrote.

The firms cited a number of court cases that established that intended use is based on the manufacturer’s claims only.

“The law does not support a determination of intended use based on actual use,” AdvaMed said.

Hyman, Phelps & McNamara attorneys pointed out that a change in FDA policy concerning off-label use could only be accomplished through notice-and-comment rulemaking.

Labs should be responsible for inappropriate uses of RUO and IUO products, firms argue.

Thermo Fisher Scientific urged FDA to strike the language from the final guidance.

The firms said it is laboratories that should be responsible for any inappropriate uses of RUO and IUO products, not manufacturers.

“Nothing in the guidance recognizes a clinical laboratory’s responsibility,” AdvaMed said. Firms may label and market a research-use-only product legally, but “a laboratory may decide to use that product clinically in an LDT irrespective of the manufacturer,” the trade group added, referring to lab-developed tests.

FDA should urge laboratories and other customers not to purchase research-use-only products with clinical uses in mind, diagnostic and imaging system maker Olympus suggested.

Labs: Clinical Uses Validated Through CLIA

Labs, on the other hand, maintain that they are free to use research and investigational products in clinical tests if they are validated under CMS’ Clinical Laboratory Improvement Amendments program, which has some oversight over clinical labs.

Labs often use RUO and IUO products in clinical tests, the American Clinical Laboratory Association wrote, and FDA should acknowledge that labs are permitted to do so if they comply with CLIA requirements.

“Laboratories are not in violation of FDA requirements in offering the tests,” ACLA said.

In any case, a firm should not be required to “immediately halt” sales to customers when it learns that RUO or IUO products are being used inappropriately, industry and lab stakeholders agreed.

The American Association for Clinical Chemistry said it was “very concerned” about the impact of the new guidance on laboratories' access to reagents, the development of new tests and the ability of testing facilities to continue their work.

“If it decides to act in this area, FDA should consider a lengthy grace period during which manufacturers are allowed to come into compliance,” ACLA added.

Back Door To Lab-Developed-Test Regulation?

Some device makers claimed the draft guidance was, in some respects, a back door to exercising more oversight over laboratory-developed tests – at the expense of companies.

“FDA has the authority to regulate LDTs, and should do so directly rather than relying upon manufacturers to regulate clinical laboratories,” Roche wrote in its comments.

AdvaMed urged FDA to release its promised lab-developed test guidance along with the research-use-only test guidance.

“FDA released this draft guidance document in advance of any guidance on the regulation of laboratory developed tests,” the trade group said. Instead of issuing its policy on LDTs, "FDA has acted indirectly to regulate these products through manufacturers that sell reagents and instruments to clinical laboratories.”

By Jessica Bylander

FDA Oversteps Its Bounds In Guidance On Research-Only Tests, Firms Say

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