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Peter Wetherall
Peter Wetherall
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FDA Not Too Underfunded to Screw Consumers

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Yesterday, I commented on the FDA’s difficulties in meeting its mandate as described in the FDA Report on Science and Technology published on December 3, 2007, by the FDA Science Board Advisory Committee. Despite the severe limitations on the FDA’s abilities set forth in that report, the FDA is forging ahead with proposed “Guidance for Industry” which would allow drug companies to distribute “off-label” use studies to physicians,

Which begs the question: Given the present functional impairments of the FDA as described by the FDA itself, why is the one action the FDA is apparently capable of making a plus for big pharma, and a slap in the face to consumers? Encouraging off-label use is one sure way to provoke the over-prescribing of a drug, and also encourages drug sales representatives to exaggerate the risk-benefit profile of the drugs they’re selling in conversations with doctors. The result will certainly be that persons will be injured who would never have used a drug except for this encouragement of its off-label use.

Forgive my cynicism, but when I see the FDA acting as an arm of big pharma in its words and deeds, it just reinforces what I already believe – the FDA is no more capable of protecting us than the drug companies themselves, and we all know how much big pharma cares. They remind us in their shiny, happy ads played incessantly throughout the nightly news.