FDA

The Food and Drug Administration directly affects your life every time you swallow a pill - Joe Graedon

FDA
FDA

image by: The U.S. Food and Drug Administration

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The F.D.A. Has Reached a New Low

In recent years, under steady pressure from the pharmaceutical industry and the patient groups it funds, the F.D.A. has progressively lowered its standards of effectiveness and safety required for drug approvals. New drugs are now more likely to be supported by fewer studies and less adequate clinical trial designs than in the past. Worse, more than half of new drugs are now approved based on what’s called surrogate endpoints — changes in the body measured by lab tests that may not reflect clinical benefit — rather than requiring that the drug affect how a person feels, functions or survives.

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 The F.D.A. Has Reached a New Low

Decades ago, drugmakers in the United States could sell medicines without demonstrating that they actually worked. That came to an end in the early 1960s after tens of thousands of women worldwide gave birth to children with severe birth defects after taking the inadequately tested drug thalidomide.

FDA

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

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