Activities

FDAAA Luncheon July 28, 2009

Rear Admiral Boris Lushniak Speaks on Counterterrorism at July FDAAA Luncheon

Rear Admiral Boris Lushniak, FDA Assistant Commissioner for Counterterrorism, described the focus activities of the Office of Counterterrorism and Emerging Threats at the FDAAA luncheon held in Rockville, MD on July 28, 2009.

The terrorist attacks of September 11, 2001 on US soil and the subsequent anthrax poisonings ushered in dramatic changes to the global concerns about terrorism and public safety. Stemming in part from these concerns, the Commissioner of FDA, Dr. Mark McClellan, formally established in 2003 what is now known as the FDA's Office of Counterterrorism and Emerging Threats (OCET). The expanded mission of this group is to develop effective counter-measures for existing or potential very serious (chemical, biological, or nuclear) events and to protect the public from emerging threats by anticipating needs and taking action (e.g., multi-drug resistant infections).

In 2004 Dr. Lushniak was brought from CDC into the FDA as Assistant Commissioner for Counterterrorism and appointed Director of the Office of Counterterrorism and Emerging Threats. Ignoring the Shakespearean threat of the "ides of March", Dr. Lushniak recalls coming to Washington with his family and his still functioning Sears alarm clock and taking office at the FDA on March 15, 2004. After 4 months 'on the job', he was ready to leave because he just didn't know the FDA language! But he persisted and not only learned the FDA language quite well, but also brought some new vocabulary to the Agency.

In his presentation Dr. Lushniak described one of the principle activities of the OCET group as "buying things", more specifically purchasing countermeasures under an emergency use authorization, which may be given to the FDA Commissioner, as specified in the Bio Shield Act (July, 2004). Under this "emergency use authorization", the OCET recommends the acquisition of certain products (e.g., drugs, vaccines, etc.) which, even if not formally approved for general use, may be 'good enough' for use as countermeasures in emergencies. These products are called "Emergency Use Acquisitions" (EUA). The conditions under which this action may be taken include (1) the determination that an emergency situation exists and (2) a DHHS declaration warranting potential "Emergency Use Authorization" to the FDA Commissioner.

The justification for the issuance of an "Emergency Use Acquisition" (EUA) for a particular product includes:

  1. existence of a very serious (chemical, biological, or nuclear) event or the real potential for one (this event is identified by a sponsor from a government office or private company who requests an EUA)
  2. it is "reasonable" to believe that the product can help (this is a lower standard than is normally used for approval of regulated products). The minimum level of "safety/efficacy" information depends on the nature of the emergency and the need for public health (basically, zero information is not negotiable but anything more than zero information is potentially negotiable).
  3. no other alternatives exist
  4. benefits of using the product outweigh the risks (risk/benefit determination).

This justifying information is incorporated into a technical report which is submitted as a recommendation to the FDA Commissioner for his/her signature to approve an EUA for a one year period (or less). This EUA process is very much event-driven and the response of the Office of Counterterrorism and Emerging Threats may involve an extremely rapid turnaround time, for example, a request for an EUA may be made on Sunday and the technical report document for EUA approval may be completed by Monday. The OCET currently has a staff of 6 employees with 1 additional person soon to come on-board. All staff members have top-secret level clearance. Inter-Center communication within the FDA is of paramount importance and each Center has a Counterterrorism coordinator who interacts regularly with the OCET. Intelligence for projecting public health needs is obtained from various sources but particularly from the FDA's Office of Security.

In the brief history of the OCET there have been at least six EUA's approved. These have involved a variety of products and product types, including for example use of anthrax vaccine for military personnel (2005), home delivery of doxycycline for anthrax treatment by postal workers (2008), pediatric use of an approved antiviral as an H1N1 treatment, and approval of an in vitro diagnostic test for H1N1.

Submitted: Thomas J. Sobotka