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FDA's Voice of the Patient Report -- Pandora Advocacy PR

Discussion in 'Action Alerts and Advocacy' started by JohnnyD, Oct 4, 2013.

  1. JohnnyD

    JohnnyD Senior Member


    FDA's Voice of the Patient Report on Chronic Fatigue Syndrome Reveals Disease Impact and Areas for Progress

    By PANDORA Org
    Published: Thursday, Oct. 3, 2013 - 12:11 pm

    GRAND RAPIDS, Mich., Oct. 3, 2013 --Patients Need Access to Treatments, Including Ampligen® and Rituxan®
    "We appreciate the response of Dr. Margaret A. Hamburg, FDA Commissioner of Food and Drugs, and Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research," said Chapo-Kroger. "However, there is still no FDA drug development guidance or clarified endpoints and outcome measures for this disease after two decades, and the April 25-26 meeting failed to focus on that topic. Therefore, more action is needed to remove these roadblocks and further facilitate drug development for this disease that is causing tremendous suffering and even death."
    At this time, no FDA-approved drug is labeled for ME/CS. In the last 20 years, at least eight drugs have been in the pipeline and with one remaining stuck. The patient organizations know that once one treatment is approved, additional research and treatments will follow; 13 drugs were approved in the nine years following the approval of AZT for HIV/AIDS.
    "The FDA has considerable latitude in determining what burden of proof a drug must meet, including the legal authority to waive well-controlled and adequate studies particularly for disorders such as ME/CFS that have no FDA-approved drugs," said Chapo-Kroger. "We expect the FDA to provide considerable creativity and flexibility."

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