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Regulatory environment impact on the adoption of whole genome sequencing

August 25, 2012 Leave a comment

Another question posted was:

  • There has been a lot of uncertainty surrounding the regulatory environment for consumer genomics. How do you see that changing in the future, if at all?

Here’re my two cents. The debate on regulatory strength around consumer genomics will seemingly continue for quite some time. Over all, I see the current regulatory rules as outdated, and can’t handle the genomics based clinical applications in a fair way. For new concepts and areas such as consumer genomics, taking caution is very necessary. The vast and overwhelming information can very well be misused and cause undesired consequences. However, simply rejecting the equally overwhelming benefit from the past two decades of innovation in the genomics space is unacceptable practice. In a bigger picture, the whole world is moving forward in applying the latest genomics advancements to clinical improvements, especially in developing countries where the regulatory system is not yet well established (one can easily read it as ‘cumbersome’). The ‘lack’ of complete regulatory system can work in the favor of innovation, and the knowledge base coming from NIH’s investment into the genomics world (and, of course, US tax payer’s money) are nurturing such innovations. If the FDA doesn’t realize this, and if the genomics community doesn’t act enough to push FDA in making changes, innovation in the US will continue the trend of decreasing and ultimately get suffocated. The US will lose one more leadership over the world in biomedicines.

Good news is that the FDA is indeed trying to catch up by issuing new guidelines and soliciting feedback from the academic and industrial community. I do think the FDA regulations will change much in response to the wake of consumer level genomics, but the worry is whether the rate will be fast enough as we in the field wish for.

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