Increasing FDA attention to genetic testing may “stifle innovation”

In a new commentary article Jennifer Wagner from the Institute for Genome Sciences and Policy at Duke University notes that further development – and success – of genetic testing requires “everyone – legislators, bioethicists, geneticists, and others – to be on a level playing field”​.

The commentary, published in The American Journal of Human Genetics​ addresses the wider topic of genetic testing, but has implications for nutrigenomics/nutrigenetic tests that are already commercially available.

Nutrigenomics is defined as how food and ingested nutrients influence the genome (personalised nutrition). Nutrigenetics is defined as how a person's genetic make-up affects a response to diet (individual nutrition).

Genetic test = medical device​

“The FDA explained during public hearings held in July that a ‘genetic test is only subject to FDA oversight if it is a medical device; that is, if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.’ That the FDA takes this position is no surprise, given the constitutional limits to the FDA’s authority under the [the Medical Device Amendments of 1976]MDA,”​ wrote Wagner.

“But what about the genetic and genomic tests not intended for such health-related purposes?”​ she asks.

Also, how can the existing rule for medical devices be applied to genetic tests, she asks. “This is far from clear and is a laborious task that will require flexibility to accommodate future genetic and genomic innovations,”​ said Wagner.

“It will be challenging, indeed, for the FDA to achieve its stated goals of ensuring public safety without simultaneously stifling scientific and medical innovation, and there seems to be no consensus as to how the FDA should proceed.”​

FDA crack-down​

2010 has seen FDA reassert itself in the genetic testing area, with a broadening of its regulatory strategy, said Wagner. Indeed, FDA issued letters to six companies in June 2010 over genetic testing, and an additional 14 letters in July. Such actions are interpreted by Wagner as “administrative actions that can be characterized as informal adjudications”​.

“In those letters, the FDA indicated it interpreted the genomic tests as falling under the statutory definition of ‘medical devices’,”​ she added.

Premature, but well intentioned​

Several companies are already offering genetic tests to physicians and consumers designed to help them plan personal nutrition based on their genetic profile, with prices reportedly ranging from $100 to $1000.

In 2008, researchers at University of California (UC) Berkeley stated that ready-to-buy human genome tests would be available for purchase for $100 within five years.

However, such products have aroused criticism and skepticism, including an article in the New Scientist​ in 2007 that stated that companies offering personalised nutrition testing are jumping the gun because the science behind nutrigenomics is not enough to support the claims.

Indeed, earlier this year, Dr Jim Kaput, director of FDA’s Division of Personalized Nutrition and Medicine, told NutraIngredients-USA that he considered the tests on market “premature, but well intentioned”. ​Dr Kaput stressed that his views were his alone and not those of FDA.

Dr Kaput added that the view of such people was that “well, someone has to start, someone has to test the water, someone has to see how the policy makers handle this, how the consumer reacts – whether they’re interested. I agree with parts of that argument,”​ he said.

“But I would claim we need to more in the non-profit organisations – in association with the companies – so that we can build the right data set,”​ he added.

“One of the things that could happen if you do it too early is that you over-promise (which has happened in genomics, let alone nutrigenomics), and that will mean that people get frustrated that we didn’t deliver what we told them,”​ said Dr Kaput.

To view the whole interview with Dr Kaput, please click here​.

A voluntary registry of genetic tests was launched earlier this year by the NIH. The registry – currently under construction – can be accessed here​.

Source: The American Journal of Human Genetics​
 October 2010, Volume 7, Pages 451-456
 "Understanding FDA Regulation of DTC Genetic Tests within the Context of Administrative Law"​
 Author: J.K. Wagner