FDA Targets Genetic Testing Services for Advertising Unapproved "Medical Devices"

FDA recently  (May 11, 2011) sent letters to two DNA testing services concerning their Direct to Consumer (DTC) advertising. The companies are Precision Quality DNA (see letter here) and Lumigenix Inc (see letter here).

Precision Quality DNA, offers a service intended to help individuals "understand the analysis of their DNA sequence while focusing on main target genes, such as BRCA1/BRCA2, to determine that individual’s main risk factors or likely response to a particular drug." FDA claims that the service "appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act."

Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:

“... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals ... [or] intended to affect the structure or any function of the body of man or other animals.”

FDA looked high and low in its files and "ha[s] been unable to identify any Food and Drug Administration (FDA) clearance or approval number for the Precision Quality DNA. We request that you provide us with the FDA clearance or approval number for the Precision Quality DNA . If you do not believe that you are required to obtain FDA clearance or approval for the Precision Quality DNA, please provide us with the basis for that determination."

Actually, Precision Quality DNA does NOT believe it requires FDA clearance and says so right on its website on a page titled "Health, Politics and Regulatory Issues" (see here). On that page, Andre Gous, Co-Founder of the company and addressee of FDA's letter, has some interesting things to say about the FDA and its authority to regulate software as a medical device, including:

"Even if you're in favor of government regulation, you're probably wondering how a 1976 FDA law could be applicable to DNA biotech -- an entire field of endeavor that was unknown to the legislature at that time. And, since that law focuses on devices, the FDA is (no surprise) also classifying more and more things, even things as ethereal as software, as a 'device.'

"If the FDA were simply deluded, that would have been bad enough already. However, the FDA didn't stop there. They mailed intimidating letters to the top 5 DNA biotech US companies, and since then they have mailed out 14 more such letters yet."

After that it's pretty much an Ayn Rand style rant; ie, government should just leave capitalists alone.

My guess is that Precision Quality DNA was not among the the "top 5 DNA biotech US companies" that previously received letters from the FDA. To paraphrase it's marketing tag line, Precision Quality DNA "Dodged the Bullet with its Name on it" from the FDA in the past, but now has to deal with that bullet. It will be interesting to see who prevails, the bullet or the target.