Precision Quality DNA - Comment

Document ID: FDA-2011-N-0066-0003
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: February 15 2011, at 12:00 AM Eastern Standard Time
Date Posted: February 18 2011, at 12:00 AM Eastern Standard Time
Comment Start Date: February 7 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: March 1 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80bef3d7
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I am the co-founder of a small biotech company. As such, I am speaking on behalf of our founders about the regulatory actions being planned by the FDA for the biotech industry: Any oversight and control should be market-based, for two reasons: moral and practical. Overview as to the moral case: Individuals have a fundamental right to negotiate their own terms as to accessing and understanding their genetic information, without any government interference getting in the way of that. “Freedom” and “Liberty” aren’t out-of-context slogans. They each presuppose the implied question: “From what?” As you look at US currency or listen to the National anthem, ask yourself whether you’re on the side of freedom and liberty, or against it. Overview as to the practical case: if you want to hobble the industry, keep extending your influence. As I observe the effect that even the mere anticipation of your involvement is having on my own business, it’s safe to say that you are already doing significant harm to consumers and service providers, both. Regulate more and you’ll simply make things worse yet. Look at the havoc that US government regulation has caused in the greater Pennsylvania and Ohio area, where US manufacturing plants could not compete with foreign, less-regulated ones. Look at how government regulations hobbled the US automobile industry in the 1970s and what that did to the Detroit area, and how far the US fell behind competition from Germany, Japan and even developing countries. The VW Fox, for example, was imported all the way from Brazil and even so it was for many a preferable choice over something built right here in the US of A. You now have the opportunity to hobble the US biotech industry, and from every indication I have, you’re going ahead with that plan. I hope you’ll stop, but if you don’t—then at least this letter will strip you of any illusions as to such actions being either the right thing or the practical thing to do.

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