Facilitating the Development of Medical Countermeasures
The U.S. Government’s efforts to counter bioterrorism are comprised of a number of essential elements for which CBER plays an integral role. One such element is the expeditious development and licensing of products to diagnose, treat or prevent disease following exposure to pathogens that have been identified as bioterrorist agents. These products must be reviewed and approved prior to the large-scale productions necessary to create and maintain a stockpile. Staff must guide the products through the regulatory process, including the manufacturing process, pre-clinical testing, clinical trials, and the licensing and approval process. Experts in these areas are needed to expedite the licensing and approval process for these products. This process is extremely complex and early involvement by staff is crucial to the success of the expedited review process.
CBER works with other federal agencies and industry, through the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) on a broad array of projects aimed at making our nation better prepared for chemical, biological, radiological, and nuclear (CBRN) threats and emerging infectious diseases through the development of new countermeasures.
In addition, CBER also monitors the impact of emergencies or outbreaks of disease on the safety and availability of the blood supply.
Preparedness for and response to an attack involving biological agents are complicated by the large number of potential agents (most of which are rarely encountered naturally), their sometimes long incubation periods and consequent delayed onset of disease, and their potential for secondary transmission. In addition to naturally occurring pathogens, agents used by bioterrorists may be genetically engineered to resist current therapies and evade vaccine-induced immunity. Pathogens that have been identified as potential biological warfare agents include those that cause anthrax, botulism, plague, smallpox, tularemia, and the hemorrhagic fevers, among others.
CBER’s regulatory science and research programs focus on developing a comprehensive approach to rapid pathogen detection, enhancing preparedness for seasonal and influenza vaccines, and facilitating licensure of medical counter-measures for treating or preventing diseases due to bioterrorist attacks. The purpose of our regulatory science program is to provide both proactive solutions to fill gaps in scientific data, tools, or approaches needed to perform regulatory review, while also providing a cadre of scientific experts that are available to be responsive to public health emergencies that may require a laboratory response.
- Cynthia L. Kelley, M.S., Senior Advisor for Counterterrorism/Medical Countermeasures
- David A. Rouse, M.S., Senior Scientist for Counterterrorism and Emerging Threats Preparedness
- Nicolette C. deVore, Ph.D., Senior Scientist and Project Manager for Counterterrorism and Emerging Threats Preparedness
Countering Bioterrorism Questions and Answers Anthrax Smallpox
- Guidance: Emergency Use Authorization of Medical Products
- Emergency Preparedness: FDA's Medical Countermeasures Initiative (MCMi)
Vaccine Safety & Availability Questions about Vaccines
- CBER Regulation of Blood and Blood Products
Science & Research (Biologics) Highlights of CBER’s Medical Countermeasure Regulatory Science and Research Program Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)