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 "DA Lays Down Health Risk Claim Law in 23andMe Warning Letter."
Following is an excerpt:
FDA tells direct-to-consumer genetic testing company 23andMe that it should immediately stop marketing its Personal Genome Service in a strongly-worded and lengthy warning letter. The firm says it will address the agency's concerns.
Providing health reports on an individual's specific diseases and conditions, carrier status, health risks and drug responses are medical device uses, requiring either premarket approval or 510(k) clearance, FDA tells the Personal Genome Service testing provider 23andMe Inc. in a Nov. 22 warning letter.
"The 23andMe warning letter is as much a guidance document as it is a warning letter," according to industry attorney Bradley Merrill Thompson.
"I think it was deliberately written to start putting companies on notice to where FDA is planning to draw the line [on] the difference between disease and wellness," says Thompson, an attorney with Epstein Becker Green.
"That said, we really still need that guidance, because there's a ton of very nuanced details about whether something is truly a disease, or wellness."
For example, Thompson explains, the agency and industry could argue over advice on cholesterol, and in FDA's mind, "managing a cholesterol level, is disease management," while others could look at managing cholesterol and say: "Well, you are just trying to manage your overall health."
