Letter to the Secretary of Health and Human Services Urging Withdrawal of FDA Guidance on Distribution of Risk Information

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Nearly 1,800 people or organizations — including individual consumers, doctors and other health professionals, academics, people working in the drug industry, pharmaceutical companies and other organizations — have responded to the Food and Drug Administration’s (FDA’s) June 2014 proposed Guidance concerning information about the safety of prescription drugs. The response, by over 99 percent, was strong opposition. The proposed guidance would undermine the authority of the agency and put patients at risk.