Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was featured in an article titled "Diagnostic Tests: FDA Draft Guidance Changes Research-Only Definition, Sets Noncompliance Penalty."

Following is an excerpt:

A draft guidance issued June 1 by the Food and Drug Administration would expand the definition of "research use only" diagnostic devices, and hold manufacturers responsible for noncompliance by clinical laboratory customers.

Thompson told BNA that FDA enforcement directed at firms that overstep the RUO is all about intended use.

Thompson said he understands why FDA decided to issue a guidance to define research-only devices. Since they do not have to be approved by the agency, or manufactured under any quality standard, some companies are using the label as a shortcut, which put patients in danger.

"Research doesn't go on forever, and FDA wanted customers to certify" that they were actually using the diagnostic device for research, Thompson said. He noted that most of the guidance does not stray from what FDA "has been saying for years."

Thompson predicted that the provision calling for a halt to sales "will be controversial. It will get a strong reaction" from labs and manufacturers.

Thompson said FDA is responsible for enforcing many of the laws based on the definition of intended use, but said the guidance was a change from its previous practice of determining intended use based on the manufacturer's conduct, rather than how a customer uses a product.

"The mantra has always been that off-label use isn't illegal, only promotion. This goes a step further," Thompson said, and has implications for other areas of off-label use.

Thompson told BNA he sees the new requirement as a burden on the manufacturers that most likely do not have the systems in place to enforce the "sale halt" provision.

"It's an integrity of process issue," he said. "Salesmen will be asked to tattle on the lab customers," which they would not do to avoid losing a commission, Thompson said. Instead, "labs and sales representatives will simply stop talking about how the product is intended to be used. It would be in their best interests not to know."

With the exception of "that one nuance," Thompson said the guidance is a positive effort by FDA.

The vague definitions about RUO products "have been a sore spot with industry for decades," Thompson said. "Companies have been trying to do the right thing. Getting this kind of clarity helps companies and levels the playing field."

Thompson said the draft guidance holds "a lot of good news for companies doing the right thing."

As for potential enforcement, Thompson said federal prosecutors already are adept at enforcing intended use violations, so potential prosecution of manufacturers who knowingly sell RUO to a lab for clinical use would not be a burden.

"FDA rarely has to go after everyone," Thompson said. One or two big-name prosecutions of egregious violators "will scare everyone else into compliance."

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