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Patient Advocates Ask FDA to Let Them Help Define Risk
Date:10/5/2011

WASHINGTON, Oct. 5, 2011 /PRNewswire-USNewswire/ -- The National Organization for Rare Disorders (NORD) and about 30 of its advocacy partners have sent letters to key officials at the Food and Drug Administration (FDA) seeking more frequent and regular opportunities to provide input on decisions related to relative risks and potential benefit for new drugs and medical devices.

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The letters are a follow-up to meetings the patient advocates had with senior FDA officials over the past few months. They include specific proposals for enhanced communication between the patient community and FDA to ensure that the voices of patients with chronic and rare diseases are heard in risk-benefit determinations and related policy decisions.

"Patients need to have opportunities to communicate with FDA medical reviewers on the risks they are willing to run in exchange for a potential though unproven benefit," said Peter L. Saltonstall, president and CEO of NORD. "For example, a patient with a serious disease and no approved therapy may have a perception of risk that is very different from that of someone who has treatment alternatives. We believe that FDA can make more informed decisions about investigational products and about which products to approve if they hear directly from patients."

The letters were sent to Dr. Theresa Mullin, Director of FDA's Department of Planning & Informatics, and Dr. Jeffrey Shuren, Director of FDA's Center for Devices and Radiological Health (CDRH). Copies were sent to Health and Human Services Secretary Kathleen Sebelius, FDA Commissioner Dr. Margaret Hamburg, and Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research (CDER).

The patient advocates note that, when they met with the FDA officials in April and May of this year, the officials asked them to f
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SOURCE National Organization for Rare Disorder (NORD)
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