FDA Seeking Public Comments on Fibromyalgia October 15th, 2013 by Pat Anson, Editor Source: tinyurl/FibroMeeting | What medications do you take to treat fibromyalgia? Do they work? How does fibromyalgia affect your daily life? Do your symptoms come and go? Those are the type of questions the Food and Drug Administration is seeking answers to at a public hearing in December on fibromyalgia. The hearing is intended to allow the FDA to obtain patients’ perspectives on the impact of fibromyalgia on their lives, as well as the effectiveness of therapies in treating it. The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression and lack of sleep. Many patients go for years before being diagnosed and medications to treat fibromyalgia are often found to be ineffective. How much time has the FDA set aside to discuss this complex disorder? Four hours. The agency does have its hands full – and not just because of the government shutdown. Fibromyalgia is one of 20 diseases the FDA is seeking input on under Patient-Focused Drug Development, an initiative that is part of the fifth authorization of the Prescription Drug User Fee Act. Although the public meeting was announced in late September, so far it has generated little attention, and many fibromyalgia patients and advocates are only now learning about it. WHEN IS THE MEETING DATE AND TIME? The meeting will be held on December 10, 2013, from 1 pm to 5 pm at the FDA’s White Oak Campus in Silver Spring, Maryland. Further information about the location and early registration can be found here. fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm363203.htm If you are unable to attend the meeting in person, you can sign up online to view a webcast. patientfocusedfibromyalgia.eventbrite/ “I hope many will weigh in with their own thoughts,” says Celeste Cooper, a retired nurse and fibromyalgia expert and advocate. “We need numbers, a show of hands, and commitment to research that not only affects us, but generations to come. Our talent is our voice.” Cooper is hopeful that the public hearing will lead to new research and treatments for fibromyalgia. “There is significant evidence that fibromyalgia is a biological illness which affects multiple body systems. Medications currently available are only partially helpful for a small percentage of patients; it is time for unbiased pharmaceutical research. We need effective medications with fewer side effects. We need research on NEW medications, not re-branding strategies of old pharmaceuticals to boost sales and increase the cost to the patient,” Cooper wrote in an email to National Pain Report.
Posted on: Mon, 11 Nov 2013 02:08:34 +0000
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