Letter to Francis Collins, Director of the National Institutes of Health, and Margaret Hamburg, Commissioner of the Food and Drug Administration - Pressing For More Info on Ebola Research and Urging Expedited Development of Vaccine

Letter

October 28, 2014

Dr. Francis Collins
Director
National Institutes of Health
U.S. Department of Health and Human Services
9000 Rockville Pike
Bethesda, MD 20892

Commissioner Margaret Hamburg
Food and Drug Administration
U.S. Department of Health and Human Services
10903 New Hampshire Avenue
Building 32, Room 2346
Silver Spring, MD 20993

Dear Dr. Collins and Commissioner Hamburg:

As public health officials continue their work to stop the spread of Ebola in West Africa, and we improve our management and control of the disease here in the United States, I write to encourage expedited development of a vaccine to prevent Ebola outbreaks in the future as well as better treatments for those who have been diagnosed with the disease.

We must be able to protect against this disease before an outbreak occurs, as well as have better treatments readily available for widespread use once the disease is present in a community. I am aware that Ebola research has historically been an area of focus for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), and I write today requesting additional information on the progress of this research.

Specifically I request the following:

-What is the long-term strategic research agenda specific to Ebola? How has such an agenda been developed in coordination with other HHS agencies and the federal government structure at large?

-What is the current status of development and clinical testing of Ebola vaccines and more targeted medical treatments? Please provide detailed information on where each product is in the research, development and testing process, as well as a reasonable timeline for when these products could be available for widespread use.

-Is there a plan in place to safely expedite the clinical trial and approval process for any Ebola vaccines or treatments?

-In recent days, we have seen private sector companies make significant commitments to Ebola vaccine development. How is NIH/FDA coordinating with and facilitating the needs of these industry leaders to find a safe and effective vaccine?

-What, if any, communication has the NIH had, and with whom, regarding the manufacturing of any vaccines or treatments to ensure a robust supply chain?

-What, if any, communication has occurred between NIH and the FDA to ensure a seamless process from clinical trials to drug approval?

I urge you to continue coordination with other agencies and industries conducting similar research. I know you will agree with me that ensuring safe and effective medical care and cures for Ebola is important in light of the current spread of disease.

Thank you for your agencies' continued efforts to address this public health threat and for your prompt response to this inquiry.

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