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CDER 2007 Update
Counterterrorism, Emergency Response
We pursue an aggressive and proactive approach to our role in helping prepare the nation for terrorist events, emerging health threats and emergency response to natural and man-made crises, including:
- Assuring the availability of safe, effective and quality medicines during a crisis.
- Addressing issues on procurement, packaging, labeling, use, storage and shelf-life extension of products in the Strategic National Stockpile (SNS).
- Utilizing regulatory mechanisms to provide emergency access to new therapies and to approved therapies used in novel ways.
- Working to protect the nation’s drug supply from attack or deliberate contamination.
- Leveraging with other federal agencies to answer scientific questions about treatments for emerging health threats and terrorist events.
- Preparing ourselves to continue operations during a crisis.
Emergency preparedness and response
- CDER assisted in the development of the content for the "Radiation Event Medical Management" website available through the National Library of Medicine, at http://remm.nlm.gov. This is an internet-based diagnostic and treatment toolkit designed for health care providers, primarily physicians, who may have to provide medical care during a radiation incident.
- We played an extensive role in the October 2007 Top Officials 4 (TOPOFF 4) counterterrorism exercise, facilitating the issuance of notional emergency use authorizations for radiation countermeasures. More than 50 CDER participants played a role in the exercise.
- CDER’s Office of Counterterrorism and Emergency Coordination established emergency coordinator positions and an emergency operations center to give the Center around-the-clock emergency management capability.
Facilitating medical countermeasure development
- We finalized our work with the Centers for Disease Control and Prevention on the ongoing human trials of gentamicin in plague in AfricaWe continue to work with the National Institute of Allergy and Infectious Diseases and the U.S. Army Medical Research Institute of Infectious Disease on monkey studies of gentamicin, ciprofloxacin, levofloxacin, ceftriaxone and doxycycline in pneumonic plague.
- FDA announced the SNS labeling rule in the Federal Register on Friday, December 28, 2007. The interim final rule provides flexibility in labeling requirements for FDA-regulated medical products in the SNS. CDER’s Office of Counterterrorism and Emergency Coordination participated in drafting this rule and is CDER’s point of contact for SNS issues.
- CDER is fully engaged with HHS’s Public Health Emergency Medical Countermeasure Enterprise (PHEMCME) (http://www.hhs.gov/aspr/barda/phemce/index.html). The Enterprise’s mission is to define and prioritize requirements for public health emergency medical countermeasures; integrate and coordinate research, early- and late-stage product development and procurement activities addressing the requirements; and set deployment and use strategies for medical countermeasures held in the SNS. CDER subject matter experts served on the PHEMCE Biological, Chemical, and Radiological/Nuclear Working Groups and helped draft requirements papers for medical countermeasures.
Pandemic influenza preparedness
- CDER approved a supplemental new drug application for Tamiflu (oseltamivir phosphate) Capsules that provides for an extension of the expiration dating from five years to seven years for 30 mg, 45 mg, and 75 mg dosage forms.
Counterterrorism guidances published in 2007
- Emergency Use Authorization of Medical Products, http://www.fda.gov/oc/guidance/emergencyuse.html, was issued July 2007. This FDA guidance explains policies for authorizing the use of an unapproved medical product or unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security.
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Date created: July 31, 2008 |
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