FDA’s Shocking Expose’ on the FDA!! “We Are Failing to Protect the American People!!”
Sunday, August 12, 2012 12:28
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This is the forth and final article on how the FDA has failed to meet its charter established by the US Congress.
Everything in this article is directly from the FDA’s own report date 2007.
Massive Failure admitted by the FDA
“In contrast to previous reports that have issued many of the same warnings, there are now sufficient data proving that failure to act in the past has jeopardized the public’s health. We, therefore, urge the FDA to develop a comprehensive plan that includes how and when the Agency will respond to these recommendations, and to report that plan to the Science Board.”
“The Subcommittee found that the FDA lacks sufficient expertise in quantitative methods, such as statistics and biomathematics, to effectively assess products and guide sponsors to design valid and informative studies.”
The Subcommittee found that the FDA also has a lack of expertise in risk/benefit assessment. Such assessments have traditionally been made informally.
Recommendations of excellent FDA reviews are seldom followed
“Our final recommendation is based in our belief that effective resolution of the issues outlined in this report is urgent. In contrast to previous reports that have issued many of the same warnings, there are now sufficient data proving that failure to act in the past has jeopardized the public’s health.”
Food Safety
“In his recent Executive Order announcing an Inter-Agency Working Group on Import Safety, President Bush stated that the current system must be fixed “within available resources.” We can state unequivocally that the system cannot be fixed “within available resources.” For example, the Coalition for a Stronger FDA estimates that an excess of $130 million is needed to devise and implement a new food import system.”
The development of medical products based on “new science” cannot be adequately regulated by the FDA
“The development of medical products based on “new science” cannot be adequately regulated by the FDA. Many Critical Path projects and pilots that have been initiated are currently at risk.”
FDA “Drugs at Risk”
The mission of getting safe and effective drugs to patients in a timely manner is currently threatened by inadequate expertise and capabilities.
FDA Mission at Risk
“The lack of new science capability/capacity places the FDA mission at risk for those many products at the leading edge of innovation. This compromises not only the public health mission since the Agency cannot effectively regulate products built on emerging science, but it also hamstrings the Agency’s ability to support innovation in the industries and markets that it regulates.
Conclusions
So, it appears that the sterling reputation enjoyed by the FDA GLOBALLY has a severe tarnish. Let us hope and pray that they get their act together so that we, the American People can rest assured that the foods we eat and the drugs we consume are safe and effective.
Currently, the FDA seems to be chasing activities that do not support their mission. The FDA is in trouble and unless we can re-focus them on real health issues and stop seeing Pharma as their real customer, will the American People finally be assured that we are safe and that the FDA is really doing its job.
We invite your comments and discussions.
