Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in an article titled "Makers Of Research-Only Tests Must Respond To Inappropriate Use — FDA Draft Guidance."
Following is an excerpt:
Diagnostics makers can be held responsible for inappropriate, clinical use of tests labeled for investigational or research use only, if they are aware of it, FDA says in new draft guidance.
"It's the first time I've ever heard FDA say that mere knowledge of how your customer uses [a research-use-only test], if they use it for a clinical purpose, is enough" to require cutting off sales to that customer, said attorney Bradley Thompson.
Thompson predicted that labs wishing to use RUO (research use only) products clinically may simply stop discussing the specifics with manufacturers. "I think labs that want to use something clinically will really avoid talking about it to a manufacturer."
"It's the whole impression created when you market the product," Thompson said, not merely how a firm labels it.
Attorney Thompson argues that this definition is too broad. "For a long time I've been debating with FDA that RUO is a narrower concept than they're using that term to describe," he said.
"There are really two kinds of products. There are RUOs where the ultimate hope is that it will turn into an IVD. That is different from a research product that is anything you might use in research to figure out basic scientific facts."
"There is no intention of ever bringing [the latter] products to market [as] an IVD."
Overall, however, Thompson views the draft guidance as a positive for the diagnostics industry in that it levels the playing field between companies that have been trying to do the right thing and those that have pushed the envelope in marketing research-use tests.
"Now everyone's on notice," he said. "I am anticipating that FDA will go out and engage in more vigorous enforcement" with this guidance in place.
