NORD and Its Members Submit Risk Letters to FDA Officials
NORD and approximately 30 other patient advocacy organizations have sent letters to key FDA officials regarding the risk tolerance of patients with rare diseases. The letters were sent on Sept. 27 to Dr. Jeffrey Shuren, Director of FDA's Center for Devices and Radiological Health, and Dr. Theresa Mullin, Director of FDA's Department of Planning & Informatics. Copies were also sent to Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA; Dr. Margaret Hamburg, FDA Commissioner; and Kathleen Sebelius, Health and Human Services Secretary.
The letters are a follow-up to meetings held with the FDA officials in April and May. They also are a response to FDA's recently issued draft guidance on "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review."
In addition to NORD, the letters are signed by about 30 NORD Member Organizations and other advocacy partners. They note that the patient community "is interested in working with FDA to establish a formal process" for input regarding risk tolerance.