Genomic testing (and personalized medicine?) runs afoul of the FDA

The Chicago Tribune reported this week that the FDA is preparing to define home genetic testing kits as “medical devices” and as such will be subject to regulation.

The FDA alerted five of the most prominent companies providing these services, including 23andme and Navigenics that, in effect, they have circumvented regulatory procedures by making DNA test kits available without submitting them to FDA procedures.   The FDA’s June 10 letter to Anne Wojcicki, CEO of 23andMe, for example, called the “23andMe Personal Genome Service” a “device” under the Federal Food, Drug and Cosmetic Act, 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 of function of the body.”

(The FDA’s letters to each of the firms can be found here.)

The FDA asserts that the firms should have submitted their services for “premarket review,” an FDA procedure that “allows for an independent and unbiased assessment of a diagnostic test’s ability to generate test results that can reliably be used to support good healthcare decisions.”

On June 11, 23andMe released its response to the FDA:

23andMe is in receipt of the FDA’s letter and will respond directly to the agency. It is important to note that we disagree with the FDA’s conclusion. Regardless, we have always been open to discussions to formulate a rational way to regulate the personal genetics industry, and we look forward to continuing those discussions with the FDA. We believe any government regulation should have an appropriate framework that does not stifle scientific innovation.

We carefully explain to our customers that the data we provide is informational and educational in nature. We also caution our customers that, if they want to use the data and information they learn about their own genetic makeup for medical decision-making, they do so in consultation with a physician or other appropriate health care professional.

23andMe initiated contact with the FDA to discuss its service in October 2007, even before officially launching the service, and those discussions have been ongoing.

We are sensitive to the FDA’s concerns, but we believe that people have a right to know as much about their genes and their bodies as they choose.

In a press release of June 3, the company perhaps anticipated this action by including this description of its services:

“Though our service delivers personalized data, the information it provides is tailored to genotypes, not to individuals (highlighting mine).  Initially, we will have no knowledge of our customers’ vital signs, disease histories, family histories, environment, or any other medically relevant information. Thus we have no way of evaluating our customers’ health or medical needs, and we make every effort to clarify this for our customers.”

This current FDA action stems apparently from mass market distribution arrangements that were to be put in place in mid-May.   Pathways Genomics was preparing to distribute it kits through Walgreen’s and CVS pharmacies.  Those plans were postponed just prior to sales.   23andMe kits are available through Amazon.com.

The Tribune quotes Dr. Muin Khoury, director of the National Office of Public Health Genomics at the CDC: “We’re at an early stage in our knowledge of the human genome…What we have now is data points, not knowledge.”

While our understanding of DNA markers is undoubtedly early in its evolution, this slight contretemps is far more than a procedural or definitional disagreement between an industry and the FDA.  Many forces are moving the consumer into the center of his or her own health decision making, exemplified by increasingly sophisticated tools, tests, and personal profiles designed to give each individual better appreciation of his or her own health status and potential.   That appreciation comes first in the form of information, which is what the genomic testing firms offer as their product.

They are not alone.   Nutritional and supplement companies and general health web site offer interactive web forms that purport to present a personal profile that can lead someone to adopt a regime of supplements or foods and engage in other wellness-inducing activities.  Like 23andMe and other DNA firms, they will argue that their only product is simply information.

The development of “personalized health” tools, in other words, is running past the expectations and requirements of the pre-personalized infrastructure that has defined the course of health and wellness advances in the past.

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