FDA flexed its jurisdictional muscle by warning 23andMe that its marketing of the 23andMe saliva test kit and personal genome service without marketing clearance or approval violated that federal Food, Drug & Cosmetic Act.
Many companies, despite considerable legal counsel (or neglecting to hire a lawyer to vet the FDA issues at the outset – oops!), find themselves in trouble with the FDA as the FDA fires off a warning letter telling the company it is marketing an unapproved medical device in violation of FDA legal rules. FDA is rigorous in enforcing its medical device and related laws.
The first question when marketing a product that addresses human health – if that product is a machine or instrument – is whether the product might be considered by the FDA to be a medical device. Medical devices range from simple tongue depressors bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device.
In the case of 23and Me, the FDA’s warning letter stated:
This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
Notice the definition of “medical device” used by the FDA: “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.” This is taken from the federal statute. Many companies mistakenly believe that simply because their product provides a reporting function, it somehow falls outside this expansive jurisdiction. The FDA quoted the language “first step in prevention” to highlight the diagnostic function.
Once the product is deemed a medical device, the company must submit an elaborate and extensive application for premarket approval (PMA), unless it can show that the product is “substantially equivalent” (SE) to one already cleared for marketing, in which case the company can submit a less burdensome, but still detailed, 510(k). FDA can request that the product still be clinically validated through extensive trials.
FDA gave 23andMe 15 days to respond. This short timeline for response is typical. Here, among the FDA’s concerns was a false positive in testing for breast cancer.
Wired reported on this as “the direct result of unintended collisions between breakthrough technologies and their more incremental regulators.” Wired writes:
Absent any real law on the subject, the agency has strained credulity to categorize 23andMe’s product as a diagnostic “device” — making it subject to its most stringent oversight. The FDA’s letter focuses intently on the potential that consumers will both under- and over-react to the genetic information revealed. The agency fears that users will pressure their doctors for potentially unnecessary surgery or medication to treat conditions for which they are genetically pre-disposed, for example. And it assumes that the costs of such information abuse outweigh any benefits — none of which are mentioned in the agency’s analysis.
The legal definition of “medical device” is broad enough to include the FDA’s exercise of jurisdictional authority. It would have been better had the company’s lawyers negotiated or worked out their FDA legal and regulatory issues before putting product to market. Although again, there has to be a balance between protecting the public, and allowing disruptive innovation to fuel the market.
As a postscript, the technology behind genomic markers still leads to inconclusive results. And 23andMe stands behind its adherence to CLIA guidelines for laboratory testing and other regulatory rules.