I welcome a tougher stance on enforcement of FDA regulations. I think that Dr. Hamburg is off to a good start. However, I have some concerns that there will be unintended consequences. First, FDA has been going after some relatively easy targets, such as internet fraud for H1N1 "remedies." Next, there needs to be a corresponding improvement on training FDA personnel so they adequately and fairly enforce the regulations. Many regulations are outdated. The clinical trial regulations date back to the 1970s and don't address today's issues.
You may read more of my viewpoints on my blog, Carl's Blog on FDA Stuff, found at: http://carl1anderson.wordpress.com/
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I welcome a tougher stance on enforcement of FDA regulations. I think that Dr. Hamburg is off to a good start. However, I have some concerns that there will be unintended consequences. First, FDA has been going after some relatively easy targets, such as internet fraud for H1N1 "remedies." Next, there needs to be a corresponding improvement on training FDA personnel so they adequately and fairly enforce the regulations. Many regulations are outdated. The clinical trial regulations date back to the 1970s and don't address today's issues.
You may read more of my viewpoints on my blog, Carl's Blog on FDA Stuff, found at: http://carl1anderson.wordpress.com/
August 9, 2009 - 12:37pmThis Comment
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