HHS Announces New Steps in Anthrax Preparedness

HHS Secretary Mike Leavitt today announced two new actions in the department’s ongoing activities to bolster the nation’s preparedness for a potential outdoor anthrax attack. In development since March of this year, the steps being implemented today build upon more than a decade of preparedness efforts across HHS and other agencies of the federal government.

The first of today’s actions focuses on United States Postal Service letter carriers who volunteer to deliver medicines directly to residences in their communities during an emergency.

Homeland Security Secretary Michael Chertoff and HHS Secretary Leavitt have invoked their authority under section 564 of the Federal Food, Drug, and Cosmetic Act to make the determination and declaration of emergency required by law in order for HHS’ Food and Drug Administration (FDA) to consider issuing an Emergency Use Authorization (EUA) allowing eligible letter carriers to receive kits containing small quantities of antibiotics for future use by them and other members of their households during an anthrax emergency. The Biomedical Advanced Research and Development Authority within HHS requested that FDA issue a EUA for this purpose.

These antibiotics would help protect volunteers against contracting anthrax if, following an outdoor anthrax attack, the Postal Service was called upon to deliver the same life-saving antibiotics directly to homes across their community where people may have been exposed to the bacterium that causes anthrax. Although no imminent threat currently exists, these legal actions would enable FDA to issue a EUA.

“In an anthrax attack, time is of the essence in preventing illness and death by getting antibiotics to those who may have been exposed,” Secretary Leavitt said. “By providing advance protection to letter carriers who volunteer to deliver antibiotics in an affected community, we can gain the benefits of the unique capabilities of the Postal Service to get much needed medicines to those who need it quickly. This is one part of our strategy to encourage preparedness at all levels of government to enable our nation to respond effectively in the event of an anthrax emergency.”

Over the past several years, under the Cities Readiness Initiative (CRI), HHS and the Postal Service have successfully developed and tested in three U.S. cities -- Seattle, Philadelphia and Boston --the ability of letter carriers to quickly deliver door-to-door quantities of antibiotics from the Strategic National Stockpile to residential addresses. This quick-strike capability is intended to buy time for local and State public health authorities to set up points of dispensing for further provision of antibiotics across the community.

“The letter carrier has long been a reliable presence in America’s neighborhoods. This important and potentially life saving undertaking is a natural extension of what the carriers see as a service to their community,” Postmaster General John E. Potter said.

Begun in 2004, CRI is a federally funded effort to prepare 72 major U.S. cities and metropolitan areas to effectively respond to a large scale bioterrorist event by dispensing antibiotics to their entire identified population within 48 hours of the decision to do so. With today’s actions, CRI cities will now have another distribution tool at their disposal when crafting their plans to protect their populations. Such innovations have been encouraged by the National Academy of Sciences’ Institute of Medicine, which earlier this year conducted an evaluation of medical countermeasure distribution capabilities.

In a related action, Secretary Leavitt today issued a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provides liability protection for activities related to developing, manufacturing, distributing, prescribing, dispensing, administering and using anthrax countermeasures in preparation for, and in response to, a potential anthrax attack. This includes entities, such as large “big-box” retail stores, retail pharmacies, and other private sector businesses, that help to deliver and distribute medicines. Providing liability protection to all involved in such efforts will help ensure their full participation and bolster response efforts.

“Preparedness is a shared responsibility that must involve all sectors of society, including the private sector, community groups, families and individuals,” Secretary Leavitt said. “We are using the authorities available to us to do all we can to support preparedness at all levels.”

The DHS Determination of an Emergency (under Section 564(b) of the Federal Food, Drug and Cosmetic Act) is available at http://www.dhs.gov/xlibrary/assets/ofsec_signed_determination092308.pdf; the HHS Declaration of an Emergency (under Section 564(b) of the Federal Food, Drug and Cosmetic Act) is available at http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/564anthrax-declaration.html; and the HHS PREP Act Declaration available at http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/prepact-081001.html.
For further information on HHS’ emergency preparedness efforts related to anthrax as well as other emergencies in general, please visit http://www.hhs.gov/emergency.