21 October 2008
In an online document
dated 17 October 2008, the US Department of Health and Human Services (HHS)
posted a notice in the US Federal Register (FR) by the HHS Secretary Michael O.
Leavitt of a “Public Readiness and Emergency Preparedness Act (PREP) Act
Declaration Regarding Botulism Countermeasures.” Find this link at: http://www.hhs.gov/disasters/discussion/planners/prepact/index.html
This HHS website,
dedicated to the Public Readiness and Emergency Preparedness (PREP) act states
that:
“A PREP Act
declaration is specifically for the purpose of providing immunity from tort liability,
and is different from, and not dependent on, other emergency declarations.”
In addition, “The
PREP Act authorizes the Secretary of the Department of Health and Human
Services (“Secretary”) to issue a declaration (“PREP Act Declaration”) that provides
immunity from tort liability (except for willful misconduct) for claims of loss
caused, arising out of, relating to, or resulting from administration or use of
countermeasures to diseases, threats and conditions determined by the Secretary
to constitute a present, or credible risk of a future public health emergency
to entities and individuals involved in the development, manufacture, testing,
distribution, administration, and use of such countermeasures.”
The US Federal
Register official notice of this Botulism Countermeasure PREP act Declaration
by HHS Secretary Leavitt is dated October 17, 2008 (Volume 73, Number 202)
pages 61864-61866.
The Botulinum toxin
covered countermeasures under this PREP Act Declaration are defined under
section IX in this Federal Register document by Secretary Leavitt to include
“any vaccine; antimicrobial/antibiotic, or other drug or antitoxin; or
diagnostic or device to identify, prevent or treat botulinum toxin or adverse
events from such countermeasures (1) licensed under section 351 of the public
Health Service Act; (2) approved under section 505 or section 515 of Federal
the Food, Drug, and Cosmetic Act (FDCA); (3) ….” The full Federal Register
notice can be found online at: http://edocket.access.gpo.gov/2008/E8-24734.htm
Appendix I to this
document lists five U.S. government Contracts as covered countermeasures for
this PREP Act declaration:
|
“Covered
Countermeasure” |
Manufacturer |
|
|
|
|
Heptavalent
antitoxin |
Cangene |
|
Heptavalent
antitoxin |
PerImmune |
|
|
|
|
Heptavalent
antitoxin, |
Cangene |
|
Monovalent E |
|
|
|
|
|
Monovalent E |
Aventis Pasteur |
|
Bivalent A and B |
Aventis Pasteur |
|
|
|
Similar PREP Act
Declarations were made for anthrax countermeasures on October 1, 2008, as well
as on October 17, 2008 for smallpox countermeasures, pandemic influenza
antivirals, and acute radiation syndrome countermeasures.
Daniel R. Lucey, MD,
MPH
EROne Institutes,
Department of Emergency Medicine
Washington Hospital
Center
Adjunct Professor of
Microbiology and Immunology
Georgetown University
Medical Center
Washington, D.C.
Website for this
posting: www.BePast.org
E-mail:DRL23@Georgetonw.edu