Bradley Merrill Thompson Quoted in Article, "FDA Targets DTC Gene Test Company, Possibly Signaling Broader Enforcement"

FDA Friday (Nov. 22) told a popular direct-to-consumer genetic testing company that its products are unapproved medical devices and should be pulled from the market -- a warning that, taken with FDA's revision last week of a broader policy on research and investigational use only in-vitro diagnostics, shows the agency plans to pursue diagnostic enforcement, said an industry attorney. ...

The action coincides with FDA's release last week of a revised guidance on in vitro diagnostics labeled for research or investigational use only. In the document, FDA shifts its stance on determining whether these products are being used inappropriately. The 2011 draft asked manufacturers to police the use of their products, drawing criticism from industry and a bill intended to blunt its effect. The updated document focuses more on the totality of the circumstances surrounding the product's distribution, such as labeling and marketing.

The revised document and the high-profile warning letter send a message, said Bradley Merrill Thompson, an attorney with Epstein Becker Green.

"I think what FDA is saying to the diagnostics industry generally is, 'We're ready for enforcement,'" Thompson said. Still, the agency's enforcement will likely be restricted to strategically chosen cases, he said. ...

Thompson said there has been a longstanding debate about whether DTC genetic testing products make wellness claims or disease-specific claims, with the latter bringing them under FDA regulation. ...

But the warning letter draws a line between wellness and disease claims in the genetic testing arena in lieu of guidance, sending a message to other similar companies, Thompson said. "FDA will oftentimes go after the most visible company in a sector to send a message to everyone else," Thompson said.