It's a Micro World after all is a blog dedicated to discussing pretty much whatever I feel like. When I delve into scientific matters it will primarily be discussing microbiology (agricultural, bioenergy, and environmental focus). Otherwise, I'll probably ramble on about sports and life.
My posts are presented as opinion and commentary and do not represent the views of LabSpaces Productions, LLC, my employer, or my educational institution.
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When you go to the FDA website and click on the link that says "About the FDA", it asks you a simple rhetorical question "Do you know ... what the FDA does?". Immediately after asking this question, they inform you with the first answer being:
FDA is responsible for
- protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation.
Note, the FDA is primarily* responsible for protecting the public health.
So, given that ... why this?
At the same time, government documents obtained by msnbc.com showed that federal Food and Drug Administration inspectors knew about problems with contamination and sterilization at a plant run by the Triad Group of Hartland, Wis., as early as July 2009.
So the Triad Group had serious issues revolving around their sterilization procedures. These issues put hundreds, if not thousands, of people at risk. The FDA knew about it, and obviously made documentation of it ... but then what?
According to FDA protocols, Triad could have received warning letters demanding corrections of violations. If the problems weren't fixed, the FDA could seize potentially tainted product, issue an injunction to stop business operations or force criminal prosecution that could lead to jail time or fines.
A search of FDA’s online warning letters database revealed no warning letters issued to H&P Industries or the Triad Group in 2009, 2010 or 2011.
So the FDA could have done something about it, and dropped the ball. People died. Not only that, they died after the FDA had begun documenting the problems with Triad Group (back in 2009, see above).
The FDA inspection reports were first completed 16 months before 2-year-old Harrison Kothari developed meningitis caused by Bacillus cereus bacteria. He died on Dec. 1, 2010.
In an time where science is under attack, and politicians are looking for the slightest reason to throw things onto the cutting room floor, this gross negligence does not reflect well on the scientific community. If the FDA, which has the primary goal of protecting the health of US citizens, cannot protect the health of US citizens ... what are they good for?
ETA: The FDA has defended their actions (or lack thereof) on the Triad Group violations.
*Nevermind that when you click on the "more after the break" link they rearrange some of the objectives (which is a shoddy webpage design).
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That's crazy. Thanks for bringing this up. What's their defense in a situation like this??
Upsetting truly is. You are right with people's safety and science on the attack, this cannot happen.
The FDA has been toothless for far too long. Look at supplements. They can't really regulate that industry, even though it should be.
And their hands are tied against larger corporations. Some guy who makes raw milk, washed rind cheeses for himself and his friends will get shut down, even if he has the know how to make it safely, but a meat packer with unsecured railings over the giant grinders will continue to operate until someone falls in.
The FDA has literally become the toothless tiger that has been chained to the porch. That and its amazing how people move back and forth so quickly without a "cooling" off period from industry to regulation and back again.