07 Oct (AHRP) – FDA, a complicit partner in crimes and corrupt industry practices have resulted in an epidemic of preventable injuries and deaths. FDA is the pivotal regulatory gatekeeper entrusted with: “protecting the public health by assuring the safety and efficacy, of drugs, biological products, medical devices, and our nation’s food supply” and “helping the public get accurate, science-based information they need to use medicines and foods to improve their health.”
FDA’s preeminent authority to determine whether a drug or device is approved is its assumed scientific expertise and honest, independent review of safety and performance data from scientifically valid, controlled clinical trials. However, FDA has radically shifted its priorities.
Surveys of FDA scientists[1] reveal widespread discontent with management for disregarding safety issues, for persistent interference with their scientific evaluations, and fear of retaliation for raising concerns about safety. A substantial number of respondents indicated that FDA decisions were overly influenced by political interests (55%) or business interests (40%). And over a third of respondents reported first-hand experience of interference in their work in the past year. [2]
FDA’s reviewing process is no longer governed by scientific evidence: the process has been corrupted under the influence of commercial expediency, which has led to the approval of unsafe, harmful drugs, vaccines and medical devices.
Numerous independent investigations by highly credible authoritative entities all confirmed serious deficiencies in FDA’s scientific base and organizational structure that severely undermine its ability to fulfill its mission.
See, Synopses of the 7 Investigative Reports Evaluating FDA Performance.
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See also: Part I: The Whole System is Broken
Part II: What Do We Get for All That Money?
Part III: The Untouchable Third Rail in Health-Care-The Vaccine