Biotech Values

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FDA issues statement regarding call to expedite process for Ebola vaccine

ATLANTA — The following is a statement from the Food and Drug Administration:

“Currently there are only experimental Ebola treatments in the earliest stages of development. Even though a drug is not approved right now, the U.S. Food and Drug Administration can still provide access to potential products through other mechanisms, such as through an emergency Investigational New Drug (IND) application. The FDA stands ready to work with companies and investigators treating these patients who are in dire need of treatment.

Regarding Ebola, the FDA is involved in an inter-agency working group led by Assistant Secretary for Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA). This working group is looking to facilitate and accelerate development of potential investigation treatments for Ebola. The FDA’s role involves sharing information about medical products in development as well as communicating our assessment of product readiness and clarifying regulatory pathways for development.

The FDA is also working with U.S. government agencies that fund medical product development and product sponsors to facilitate the development of and access to medical products that could potentially be used to mitigate Ebola. For example, the FDA granted Fast Track Designation to an investigational anti-Ebola therapeutic being developed with support from the U.S. Department of Defense in March 2014 (http://investor.tekmirapharm.com/releasedetail.cfm?ReleaseID=830680). Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

While the FDA cannot comment on the development of specific medical products, it’s important to note that every FDA regulatory decision is based on a risk-benefit assessment that includes the context of use for the product and the patient population being studied. A clinical hold is based on the risk-benefit assessment for a proposed study. A future proposal for a study or emergency use in a different population, for example in patients with disease, might have an acceptable risk-benefit balance. If the benefits of studying the product on an individual outweigh the risks, we may consider permitting that study to proceed.”

http://m.wsbtv.com/news/news/local/fda-issues-statement-regarding-call-expedite-proce/ngtLD/