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

ollow up with a proposal outlining specifics for more frequent and regular communication between the patient community and FDA on benefit-risk determinations. While mechanisms currently exist for patient input on this topic, they add, the opportunity to provide such input doesn't necessarily occur at the time that critical issues are being deliberated and may not represent a broad spectrum of patient views.

"We have had discussions at length within the patient community as to what the most appropriate milestones should be for patient contribution," the letters note. They go on to say that the rare disease patient advocates have concluded that the two milestones should be:

1) When the IND (Investigational New Drug Application) or IDE (Investigational Device Exemption) is filed and,

2) Any point at which the agency (FDA) decides, based on issues related to risk, that it must disapprove or delay commencement of a clinical trial or impose an unscheduled suspension on an existing clinical trial.

In addition to laying out specific suggestions as to how and when patient input might be submitted, the letters propose that FDA create a portal on its website, www.fda.gov, where it can post specific requests for patient contributions to certain issues.

"The patient groups who have signed this letter represent a broad spectrum of diseases, some rare and some more common. But all patients with chronic or rare diseases know that the benefit-risk ratio for any new drug or device is an important consideration," said Diane Dorman, NORD's vice president of public policy. "We are pleased that the patient community has been able to band together to bring these proposals to the FDA, and that senior FDA officials have been so receptive."

NORD is an umbrella organization providing advocacy on behalf of the 30 million Americans with rare diseases, working with its member organizations, which represent patients with
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SOURCE National Organization for Rare Disorder (NORD)
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