Volume 5, Number 4—August 1999
THEME ISSUE
Bioterrorism
Perspective
Vaccines, Pharmaceutical Products, and Bioterrorism: Challenges for the U.S. Food and Drug Administration
Table
Proposed activities of the U.S. Food and Drug Administration to counter bioterrorism
| 1. Enhancing the expeditious development and licensure of new vaccines and biological therapeutics through research and review activities—anthrax vaccine and antisera to botulinum toxin, for example. |
| 2. Enhancing the timeliness of application reviews of new drugs and biological products and new uses of existing products. |
| 3. Participating in the planning and coordination of public health and medical response to a terrorist attack involving a biological or chemical agent(s). |
| 4. Participating in the development of rapid detection and decontamination for agents of bioterrorism such as Clostridium botulinum toxins, Yersinisa pestis, Bacillus anthracis. |
| 5. Ensuring the safety of regulated foods, drugs, medical devices, and biological products; arrange for seizure and disposal of affected products. |
| 6. Developing techniques for detection of genetic modifications of microorganisms to make them more toxic or antibiotic-or vaccine-resistant. |
| 7. Rapidly determining a microbe's sensitivity to drug therapy. |
| 8. Determining the mechanism of replication and pathogenicity or virulence of identified organisms including elements that can be transferred to other organisms to circumvent detection, prevention, or treatment |
| 9. Enhancing adverse product reporting surveillance capabilities. |
