FDA Postpones Public Meeting

FOOD AND DRUG ADMINISTRATOIN MEETING CANCELLATION

Sadly, the long awaited Food and Drug Administration meeting on December 10, 2013, was postponed because of inclement weather.  It was not good news for many people with fibromyalgia who had paid for transportation and lodging to attend and represent the greater FM community at this important FDA patient meeting. Besides the financial strain of this event, it was physically difficult for some to make the journey.  Jan Chambers, NFMCPA President, traveled to Silver Spring, Maryland, just to find herself stuck in a hotel room watching the snow fall and learning the disappointing news regarding cancellation of the meeting.  

The FDA will announce a new date for the rescheduled meeting.  Until then, please remember to submit your comments about specific fibromyalgia topic questions before February 10, 2014 (http://www.fmcpaware.org/fibromyalgia/fda-december-10-2013-meeting.html).  

Jan was prepared to deliver information in her testimony regarding preliminary data from the FDA Survey created by Robert Bennett, MD and the NFMCPA.  Dr. Bennett is working on survey analysis which will soon be completed and shared with NFMCPA constituents.  The final version of the report will be shared with the FDA as information reflective of a broad spectrum of patients with FM.  Following are a few interesting responses that reveal insights into patients’ views of symptoms and treatments:

  • 2,316 people completed the survey
  • The median age was 53.1± 11.2
  • The average duration of chronic pain was 17.6 ± 11.1 years
  • 30.6 % of the participants saw more than 5 doctors before getting a diagnosis
  • The largest percentages of comorbid diagnoses were as follows: chronic low back pain; migraine, systemic lupus (SLE), TMJ, major depression, myofascial pain, and chronic upper back pain
  • The highest percentages of non-pain problems included:  stiffness, physical weakness, reduced mental acuity, difficulty focusing, cold intolerance, weather change affect, insomnia, daytime sleepiness, poor balance and noise intolerance
  • Most effective reported treatments included hot bath/hot tub, pacing, message, stretching, walking, hydrocodone, and physical therapy

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