Scary Anthrax Rip off

Despite the absence of any anthrax infections among Americans, on October
1, 2008  Mike Leavitt, Secretary of the Department of Health and Human
Service (DHHS) declared a seven-year anthrax emergency through the end of
2015.

Below, AHRP board member, Meryl Nass, MD, questions the legitimacy of that
declared Anthrax “emergency,” noting that over the past month, in the waning
days of the Bush administration, and with no emergency in sight, DHHS is
using the Public Readiness and Emergency Preparedness Act against Americans
(PREPA) to give “blanket immunity from liability to all entities involved
with the manufacturer and distribution of anthrax countermeasures, including
“government program planners.”

The liability provision of PREPA offers broad legal protection for the
makers of drugs, vaccines, and other medical “countermeasures” used–simply
when the DHHS secretary declares an emergency.

Dr. Nass provides documented background behind this last ditch effort to
expand the market for anthrax vaccine–by increasing the US stockpile of the
vaccine–adding $500 million–and by unleashing the controversial vaccine on
civilians–despite continued doubt about the vaccine’s safety.

~~~~~~~~~~~
DHHS DESIGNATES AN ANTHRAX EMERGENCY IN ORDER TO PROTECT–ITSELF!

A series of coordinated moves designed to encourage new uses for anthrax
vaccine (whose safety record is terrible and effectiveness unknown)-while
excluding any manufacturer liability for its use, preempting state and local
laws designed to protect citizens, and extending blanket immunity to
government officials who came up with the plan— is in process.

* First, DHHS Secretary Leavitt declared that the US is in an anthrax
emergency.  This invoked the Public Readiness and Emergency Preparedness
Act, giving blanket immunity from liability to all entities involved with
the manufacturer and distribution of anthrax countermeasures, including
“government program planners”
* Second, Leavitt contracted to buy $400 million worth of anthrax
vaccine, in addition to over $500 million currently in DHHS’ stockpile
* Third, CDC (a DHHS agency) asked its vaccine advisory committee to
vote on changing its previous recommendation for anthrax vaccine on October
22, potentially expanding its use to civilian “first responders”
* Fourth, the vaccine’s manufacturer is constructing a new
manufacturing plant to supply up to 30 million vaccine doses yearly.
* Fifth, CDC conducted a clinical trial of anthrax vaccine in 1564
subjects, but released only partial information on the trial in a JAMA
article published October 1, implying that the vaccine is safe.  Yet 229
severe adverse events and 7 deaths occurred in trial participants, but were
barely mentioned in CDC’s report.

**  Background

The original bill under which Secretary Leavitt made his Declaration, the
Public Readiness and Emergency Preparedness Act (PREPA, part of P.L.
109-148) gave the DHHS Secretary the right to declare any disease an
emergency, triggering immunity from liability for any and all injuries due
to countermeasures for that illness, unless “willful misconduct” by those
who made or administered the product could be proven. The Act fails to
specify any criteria for determining that an emergency exists, and fails to
fund a compensation mechanism.  It was tacked on to the end of the 2006
Defense Appropriations Bill during the night, after being removed from
another bill due to its controversial nature.  It was passed by Congress and
signed into law on December 30, 2005.  Probably few in Congress read it
before approving it along with defense spending.  You can read the bill at:
ftp://ftp.hrsa.gov/countermeasurescomp/Public_Readiness_and_Emergency_Prepar
edness_Act.pdf

In a news release issued after the bill passed, Senator Frist, R-TN said the
measure “extends limited protections to manufacturers, distributors, and
first responders, so that life-saving countermeasures, such as an H5N1 avian
flu vaccine, will be developed, deployed and administered.”
http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liab
ility.html

But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with
consumer groups such as Public Citizen, derided the liability provision as a
giveaway to the drug industry. Kennedy said the bill makes it “essentially
impossible” for injured parties to sue for damages. He also argued that the
measure allows the HHS secretary to use many common diseases as a reason to
activate the liability shield.  “Without a real compensation program, the
liability protection in the defense bill provides a Christmas present to the
drug industry and bag of coal to everyday Americans,” stated a Dec 21 news
release issued by Kennedy and Sens. Tom Harkin, D-Iowa, and Chris Dodd,
D-Conn.

The Democratic Senators introduced a new bill to supersede PREPA in February
2006, http://www.fas.org/biosecurity/resource/legislation/s2291.htm
but it never passed.

**  Where is the Anthrax Emergency?

Over the past month, in the waning days of the Bush administration, and with
no emergency in sight, DHHS is using PREPA against Americans to shield not
only manufacturers and medical professionals, but also to immunize everyone
in government who worked on the plan from any liability for problems that
arise.
Yes, you heard correctly:  although the media never reported on this
provision when PREPA was passed, the bill specifically shields “government
program planners” who deal with PREPA’s emergencies from all potential
liability.

On October 1, 2008 DHHS Secretary Mike Leavitt declared an anthrax emergency
under the PREPA Act, through the end of 2015.  (That sounds like a very long
emergency-or a very long time to enjoy liability protection.)
http://edocket.access.gpo.gov/2008/E8-23547.htm Despite the current absence
of anthrax infections in Americans, the “emergency” has been declared, and
the liability shield is already in effect for anthrax vaccine and other
anthrax countermeasures, including antiserum, monoclonal antibodies and
multiple antibiotics.

$500 million in new anthrax vaccine spending
October 1, 2008 was a busy day in the anthrax world.  DHHS announced it was
going to purchase an additional 14.5 million doses of anthrax vaccine, for a
cost between $364 and $404 million, to add to its existing stockpile of
about 25 million doses.
http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100102
951.html

The manufacturer, Emergent BioSolutions, crowed about the liability
protection it had just received for the purchase.
http://www.bizjournals.com/baltimore/stories/2008/10/06/daily45.html

Furthermore, on September 26, DHHS announced contracts for a total $113.6
million with Emergent BioSolutions and Pharmathene for development of “Third
Generation” anthrax vaccines.  These too are covered under Secretary
Leavitt’s Declaration.   What vaccines are these?  Emergent bought its
competitor VaxGen’s vaccine for $2 million, after taxpayers and investors
paid over $200 million for its development.  When in 2006 VaxGen failed to
meet DHHS-specified milestones, its contract was cancelled and the company
folded.

Pharmathene bought Avecia’s vaccine, after Avecia received a $100 million
DHHS contract for early vaccine development, but failed to get a more
lucrative contract later.
Bottom line:  both these vaccines were rejected by DHHS during the past five
years, only to suddenly arise again, and consume additional taxpayer
largesse.  Yet if the current vaccine were truly acceptable, a newer vaccine
would be unnecessary.

**  Expanding the anthrax vaccine market

If DHHS simply planned to stockpile more anthrax vaccine, its purchase would
be just another example case of government waste.  The current stockpile is
expiring at a rate of  $10 million per month, as pointed out by GAO last
year.
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/22/AR2007102202
111.html

But DHHS had bigger plans than this.  It eyed a new market for the vaccine,
one that might double or quadruple the amount of vaccine now used by the
military, justifying a new manufacturing plant that manufacturer Emergent Biosolutions is building in
Maryland.  There are up to 3 million “First Responders” in the US: Police,
Firefighters, Emergency Medical Technicians and others.  Maybe they could
profitably use the vaccine, since they might someday face an anthrax
emergency.

On October 22, the CDC ‘s Advisory Committee on Immunization Practices
(ACIP) will vote on whether to overturn its anthrax vaccine recommendations
of 2000 and 2002.
http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf

Back then, ACIP stated that neither the benefit nor the risk for using anthrax vaccine
could not be calculated, and therefore ACIP recommended against its use for
civilians, unless they would be repeatedly exposed to anthrax spores.

2000 Recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm

2002 recommendations: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5145a4.htm

**  Risk-Benefit Analysis, the Basis for Public Health Policy-Except In This Case

But, you might argue, first responders and other citizens still cannot
assess the risks and benefits of anthrax vaccination.  Let that be no
deterrent.  As CDC’s Nancy Messonier pointed out to ACIP members in June,

“The intent of the workgroup was to open the door, knowing that the vaccine
is commercially available and that first responder groups are at liberty to
call the manufacturer to obtain the vaccine themselves.  This is really
meant to give them more impetus by saying that even if they do not have a
calculated risk assessment, individuals or groups can assess their own risk,
and weigh the risks and benefits of the vaccine with their occupational
health and safety programs.”
http://www.cdc.gov/vaccines/recs/ACIP/downloads/min-jun08.pdf

CDC’s Messonier tossed aside meaningful risk/benefit assessment, the most basic public health requirement, by
suggesting that first responders can (and should) weigh their own risk, even though the
vaccine’s safety and efficacy remain in doubt, and the risk of anthrax is
unknown!  CDC doesn’t want these little omissions to stand in the way of
increasing vaccine use: especially when ACIP members and all federal employees are now shielded from liability for uninformed and ill-considered anthrax vaccine recommendations.

CDC seems to have accurately calculated its own risk/benefit equation.

Meryl Nass, MD
October 14, 2008

fyi, here is an excellent discussion of the 2005 PREPA Bill:
http://www.cidrap.umn.edu/cidrap/content/influenza/biz-plan/news/dec2805liab
ility.html

Pandemic funding, liability shield clear Congress

Dec 28, 2005 (CIDRAP News) – Before adjourning last week, the US Senate
passed and sent to President Bush a bill providing $3.8 billion for pandemic
influenza preparedness and a controversial liability shield for those who
produce and administer drugs and vaccines used in a declared public health
emergency.

The preparedness funding and liability protection were part of the fiscal
year 2006 defense spending bill passed by the Senate on the evening of Dec
21. The bill had cleared the House 2 days earlier.

The $3.8 billion for pandemic preparedness is a little more than half of the
$7.1 billion Bush had requested in early November. House Republican leaders
said last week the measure would fund roughly the fiscal year 2006 portion
of Bush’s request.

As reported previously, the amount includes $350 million to improve state
and local preparedness and directs the Department of Health and Human
Services (HHS) to use most of the rest on “core preparedness activities,”
including increasing vaccine production capacity, developing vaccines, and
stockpiling antiviral drugs.

The liability provision offers broad legal protection for the makers of
drugs, vaccines, and other medical “countermeasures” used when the HHS
secretary declares an emergency. The provision says people claiming injury
from a medical countermeasure can sue only if they prove “willful
misconduct” by those who made or administered it. The bill calls for
Congress to set up a compensation program for injuries, but it provides no
funds for that purpose.

Senate Majority Leader Bill Frist, R-Tenn., and other Republican leaders
argued that the liability measure was necessary to induce biotechnology
companies to develop products to counter pandemic flu and other disease
threats.

In a news release issued after the bill passed, Frist said the measure
“extends limited protections to manufacturers, distributors, and first
responders, so that life-saving countermeasures, such as an H5N1 avian flu
vaccine, will be developed, deployed and administered.”
He added that the bill “strikes a reasonable balance where those who are
harmed will be fairly compensated and life-saving products will be available
in ample supply to protect and treat as many Americans as possible.”

But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with
consumer groups such as Public Citizen, derided the liability provision as a
giveaway to the drug industry. Kennedy said the bill makes it “essentially
impossible” for injured parties to sue for damages. He also argued that the
measure allows the HHS secretary to use many common diseases as a reason to
activate the liability shield.

“Without a real compensation program, the liability protection in the
defense bill provides a Christmas present to the drug industry and bag of
coal to everyday Americans,” stated a Dec 21 news release issued by Kennedy
and Sens. Tom Harkin, D-Iowa, and Chris Dodd, D-Conn.

The liability protection language, called the Public Readiness and Emergency
Preparedness Act, was tacked onto the end of the huge defense-spending bill
(H.R. 2863).

It gives the HHS secretary authority to trigger the liability protection by
declaring an emergency if he or she determines that a disease or other
health threat represents an emergency or may constitute an emergency in the
future. The act does not list any criteria for determining the existence of
an emergency. The declaration would have to list the diseases, populations,
and geographic areas covered and when the emergency would end.

Such an emergency declaration is not subject to court review, and it
preempts any conflicting laws or regulations of states or local communities,
the act says.

The measure says those who make and administer medical countermeasures
covered by an emergency declaration are immune to lawsuits unless the
plaintiff can provide clear evidence of willful misconduct that resulted in
death or serious physical injury. “Willful misconduct” is ruled out if the
party who administered the treatment followed HHS recommendations and
notified health authorities of the relevant injury within 7 days.

In addition, the act instructs the HHS secretary to write regulations “that
further restrict the scope of actions or omissions by a covered person” that
constitute willful misconduct.
A party alleging “willful misconduct” can file suit only in US District
Court in Washington, DC. The plaintiff must have an affidavit supporting the
suit from a physician who did not treat the injured person. Before any suit
can go to trial, a three-judge panel will consider any pretrial motions.
The act says that an HHS emergency declaration will trigger the
establishment of a fund to provide “timely, uniform, and adequate
compensation” to anyone injured by covered medical countermeasures. However,
the measure does not appropriate money for the fund.

A person claiming injury from a covered treatment may not sue without first
trying to collect from the compensation fund. But that requirement applies
only if the compensation program has been funded. A person can sue if HHS
fails to act on the request for compensation within 240 days.
If a plaintiff accepts an award from the compensation fund, he or she is
barred from suing anyone, the act provides.

In arguing that the liability shield is too broad, Kennedy said in his news
release, “The Bush administration could identify Vioxx as a needed
countermeasure to treat the arthritis epidemic or to treat pain associated
with flu, and completely immunize Merck [the manufacturer] from lawsuits
currently pending against it.”

http://edocket.access.gpo.gov/2008/E8-23547.htm

[Federal Register: October 6, 2008 (Volume 73, Number 194)]

[Notices]

[Page 58239-58242]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr06oc08-76]

=======================================================================

———————————————————————–

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Declaration Under the Public Readiness and Emergency Preparedness

Act

October 1, 2008.

AGENCY: Office of the Secretary (OS), Department of Health and Human

Services (HHS).

ACTION: Notice.

———————————————————————–

SUMMARY: Declaration pursuant to section 319F-3 of the Public Health

Service Act (42 U.S.C. 247d-6d) to provide targeted liability

protections for anthrax countermeasures based on a credible risk that

the threat of exposure to Bacillus anthracis and the resulting disease

constitutes a public health emergency.

DATES: This notice and the attached declaration are effective as of the

date of signature of the declaration.

FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, Assistant

Secretary for Preparedness and Response, Office of the Secretary,

Department of Health and Human Services, 200 Independence Avenue, SW.,

Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free

number).

HHS Secretary’s Declaration for Utilization of Public Readiness and

Emergency Preparedness Act for Anthrax Countermeasures

Whereas significant changes in the nature, regularity and degree of

threats to health posed by the use of infectious agents as weapons of

biological warfare have generated increased concern for the safety of

the general American population particularly following the deliberate

exposure of citizens in the

[[Page 58240]]

United States to Bacillus anthracis (B. anthracis) spores in 2001 that

demonstrated the ease of dissemination, infectivity, and mortality;

Whereas the Secretary of Homeland Security has determined that B.

anthracis and multi-drug-resistant B. anthracis present a material

threat against the United States population, sufficient to affect

national security;

Whereas there are covered countermeasures to treat, identify, or

prevent adverse health consequences or death from exposure to B.

anthracis;

Whereas such countermeasures, including vaccines, antimicrobials/

antibiotics, and antitoxins for pre-exposure and post-exposure

prevention and treatment, diagnostics to identify such exposure, and

additional countermeasures for treatment of adverse events arising from

use of these countermeasures exist or may be the subject of research

and/or development;

Whereas such countermeasures may be used and administered in

accordance with Federal contracts, cooperative agreements, grants,

interagency agreements, and memoranda of understanding, and may also be

used and administered at the Regional, State, and local level in

accordance with the public health and medical response of the Authority

Having Jurisdiction;

Whereas, the possibility of governmental program planners obtaining

stockpiles from private sector entities except through voluntary means

such as commercial sale, donation, or deployment would undermine

national preparedness efforts and should be discouraged as provided for

in section 319F-3(b)(2)(E) of the Public Health Service Act (42 U.S.C.

247d-6d(b)) (“the Act”);

Whereas, immunity under section 319F-3(a) of the Act should be

available to governmental program planners for distributions of Covered

Countermeasures obtained voluntarily, such as by (1) Donation; (2)

commercial sale; (3) deployment of Covered Countermeasures from Federal

stockpiles; or (4) deployment of donated, purchased, or otherwise

voluntarily obtained Covered Countermeasures from State, local, or

private stockpiles;

Whereas, the extent of immunity under section 319F-3(a) of the Act

afforded to a governmental program planner that obtains covered

countermeasures except through voluntary means is not intended to

affect the extent of immunity afforded other covered persons with

respect to such covered countermeasures.

Whereas, in accordance with section 319F-3(b)(6) of the Act, I have

considered the desirability of encouraging the design, development,

clinical testing or investigation, manufacturing, labeling,

distribution, formulation, packaging, marketing, promotion, sale,

purchase, donation, dispensing, prescribing, administration, licensing,

and use of such countermeasures with respect to the category of disease

and population described in sections II and IV below, and have found it

desirable to encourage such activities for the covered countermeasures;

and

Whereas, to encourage the design, development, clinical testing or

investigation, manufacturing and product formulation, labeling,

distribution, packaging, marketing, promotion, sale, purchase,

donation, dispensing, prescribing, administration, licensing, and use

of medical countermeasures with respect to the category of disease and

population described in sections II and IV below, it is advisable, in

accordance with section 319F-3(a) and (b) of the Act, to provide

immunity from liability for covered persons, as that term is defined at

section 319F-3(i)(2) of the Act, and to include as such covered persons

such other qualified persons as I have identified in section VI of this

declaration;

Therefore, pursuant to section 319F-3(b) of the Act, I have

determined there is a credible risk that the threat of exposure of B.

anthracis and the resulting disease constitutes a public health

emergency.

I. Covered Countermeasures (As Required by Section 319F-3(b)(1) of the

Act)

Covered Countermeasures are defined at section 319F-3(i) of the

Act. At this time, and in accordance with the provisions contained

herein, I am recommending the manufacture, testing, development,

distribution, dispensing; and, with respect to the category of disease

and population described in sections II and IV below, the

administration and usage of anthrax countermeasures as defined in

section IX below. The immunity specified in section 319F-3(a) of the

Act shall only be in effect with respect to: (1) Present (see Appendix

I) or future Federal contracts, cooperative agreements, grants,

interagency agreements, or memoranda of understanding involving

countermeasures that are used and administered in accordance with this

declaration, and (2) activities authorized in accordance with the

public health and medical response of the Authority Having Jurisdiction

to prescribe, administer, deliver, distribute or dispense the Covered

Countermeasure following a declaration of an emergency, as defined in

section IX below. In accordance with section 319F-3(b)(2)(E) of the

Act, for governmental program planners, the immunity specified in

section 319F-3(a) of the Act shall be in effect to extent they obtain

Covered Countermeasures through voluntary means of distribution, such

as (1) Donation; (2) commercial sale; (3) deployment of Covered

Countermeasures from Federal stockpiles; or (4) deployment of donated,

purchased, or otherwise voluntarily obtained Covered Countermeasures

from State, local, or private stockpiles. For all other covered

persons, including other program planners, the immunity specified in

section 319F-3(a) of the Act shall, in accordance with section 319F-

3(b)(2)(E) of the Act, be in effect pursuant to any means of

distribution.

This declaration shall subsequently refer to the countermeasures

identified above as “Covered Countermeasures.”

This declaration shall apply to all Covered Countermeasures

administered or used during the effective time period of the

declaration. This declaration also shall apply to all Covered

Countermeasures (see Appendix I) administered or used by or on behalf

of the Department of Defense.

II. Category of Disease (As Required by Section 319F-3(b)(2)(A) of the

Act)

The category of disease, health condition, or threat to health for

which I am recommending the administration or use of the Covered

Countermeasures is anthrax, which may result from exposure to B.

anthracis.

III. Effective Time Period (As Required by Section 319F-3(b)(2)(B) of

the Act)

With respect to Covered Countermeasures administered and used in

accordance with present or future Federal contracts, cooperative

agreements, grants, interagency agreements, or memoranda of

understanding, the effective period of time of this Declaration

commences on signature of the declaration and extends through December

31, 2015.

With respect to Covered Countermeasures administered and used in

accordance with the public health and medical response of the Authority

Having Jurisdiction, the effective period of time of this Declaration

commences on the date of a declaration of an emergency and lasts

through and includes the final day that the emergency declaration is in

effect including any extensions thereof.

[[Page 58241]]

IV. Population (As Required by Section 319F-3(b)(2)(C) of the Act)

Section 319F-3(a)(4)(A) of the Act confers immunity to

manufacturers and distributors of the Covered Countermeasure,

regardless of the defined population.

Section 319F-3(a)(3)(C)(i) of the Act confers immunity to covered

persons who may be a program planner or qualified persons with respect

to the Covered Countermeasure only if a member of the population

specified in the declaration as persons who use the Covered

Countermeasure or to whom such a Covered Countermeasure is

administered, is in or connected to the geographic location specified

in this declaration, or the program planner or qualified person

reasonably could have believed that these conditions are met.

The populations specified in this declaration are all persons who

use a Covered Countermeasure or to whom a Covered Countermeasure is

administered in accordance with this declaration, including, but not

limited to: Department of Defense military personnel and supporting

civilian-employee and contractor personnel; any person conducting

research and development of Covered Countermeasures directly by the

Federal government or pursuant to a contract, grant, or cooperative

agreement with the Federal government; any person who receives a

Covered Countermeasure from persons authorized in accordance with the

public health and medical emergency response of the Authority Having

Jurisdiction to prescribe, administer, deliver, distribute, or dispense

the Covered Countermeasure, and their officials, agents, employees,

contractors, and volunteers following a declaration of an emergency;

any person who receives a Covered Countermeasure from a person

authorized to prescribe, administer or dispense the countermeasure or

who is otherwise authorized under an Emergency Use Authorization; any

person who receives a Covered Countermeasure as an investigational new

drug in human clinical trials being conducted directly by the Federal

government or pursuant to a contract, grant, or cooperative agreement

with the Federal government.

V. Geographic Area (As Required by Section 319F-3(b)(2)(D) of the Act)

Section 319F-3(a) of the Act applies to the administration and use

of a Covered Countermeasure without geographic limitation.

VI. Qualified Persons (As Required by Section 319F-3(i)(8)(B) of the

Act)

With regard to the administration or use of a Covered

Countermeasure, Section 319F-3(i)(8)(A) of the Act defines the term

“qualified person” as a licensed individual who is authorized to

prescribe, administer, or dispense the Covered Countermeasure under the

law of the State in which such Covered Countermeasure was prescribed,

administered or dispensed. Additional persons who are qualified persons

pursuant to section 319F-3(i)(8)(B) are the following: (1) Any person

who is authorized to prescribe, administer, deliver, distribute or

dispense Covered Countermeasures to Department of Defense military

personnel and supporting civilian-employee and contractor personnel,

(2) Any person authorized in accordance with the public health and

medical emergency response of the Authority Having Jurisdiction to

prescribe, administer, deliver, distribute or dispense Covered

Countermeasures, and their officials, agents, employees, contractors

and volunteers, following a declaration of an emergency, and (3) Any

person authorized to prescribe, administer, or dispense Covered

Countermeasures or who is otherwise authorized under an Emergency Use

Authorization, including, but not limited to Department of Defense

military personnel and supporting civilian employee and contractor

personnel.

VII. Additional Time Periods of Coverage After Expiration of

Declaration (As Required by Section 319F-3(b)(3)(B) of the Act)

I have determined that, upon expiration of the time period

specified in Section III above, an additional twelve (12) months is a

reasonable period to allow for manufacturers and other covered persons

to take such other actions as are appropriate to limit the

administration or use of the Covered Countermeasure, and the liability

protection of section 319F-3(a) of the Act shall extend for that

period. Further, as to doses shipped by the CDC to the DoD pursuant to

the DoD/CDC Interagency Agreement (IAA) dated March 10, 2008, an

additional period of time of liability protection shall extend for as

long as the SNS or its successor exists and the IAA remains in effect,

plus, if the additional twelve (12) months following the time period in

Section III above has expired, an additional twelve (12) months upon

expiration of the IAA.

VIII. Amendments

This declaration has not previously been amended. Any future

amendment to this declaration will be published in the Federal

Register, pursuant to section 319F-3(b)(4) of the Act.

IX. Definitions

For the purpose of this declaration, including any claim for loss

brought in accordance with section 319F-3 of the PHS Act against any

covered persons defined in the Act or this declaration, the following

definitions will be used:

Administration of a Covered Countermeasure: As used in Section

319F-3(a)(2)(B) of the Act includes, but is not limited to, public and

private delivery, distribution, and dispensing activities relating to

physical administration of the Covered Countermeasures to patients/

recipients, management and operation of delivery systems, and

management and operation of distribution and dispensing locations.

Anthrax Countermeasure: Any vaccine; antimicrobial/antibiotic,

other drug or antitoxin; or diagnostic or device to identify, prevent

or treat anthrax 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 the Federal Food, Drug,

and Cosmetic Act (FDCA); (3) cleared under section 510(k) of the FDCA;

(4) authorized for emergency use under section 564 of the FDCA ; (5)

used under section 505(i) of the FDCA or section 351(a)(3) of the PHS

Act, and 21 CFR Part 312; or (6) used under section 520(g) of the FDCA

and 21 CFR part 812.

Authority Having Jurisdiction: The public agency or its delegate

that has legal responsibility and authority for responding to an

incident, based on political or geographical (e.g., city, county,

tribal, State, or Federal boundary lines) or functional (e.g., law

enforcement, public health) range or sphere of authority.

Covered persons: As defined at section 319F-3(i)(2) of the Act

include the United States, manufacturers, distributors, program

planners, and qualified persons. The terms “manufacturer,”

“distributor,” “program planner,” and “qualified person” are

further defined at sections 319F-3(i)(3), (4), (6), and (8) of the Act.

Declaration of an emergency: A declaration by any authorized local,

regional, State, or federal official of an emergency specific to events

that indicate an immediate need to administer and use anthrax

countermeasures, with the exception of

[[Page 58242]]

a federal declaration in support of an emergency use authorization

under section 564 of the FDCA unless such declaration specifies

otherwise.

This first day of October, 2008.

Michael O. Leavitt,

Secretary of Health and Human Services.

Appendix I–List of U.S. Government Contracts

—————————————————————————————————————-

Contract                      Manufacturer          Covered countermeasure    PL 85-804  coverage*

—————————————————————————————————————-

HHSO100200500007C……………….  Cangene…………….  Anthrax immune globulin–    No.

AIG.

HHSO100200500006C……………….  HGS………………..  Anthrax monoclonal antibody- No.

ABThrax.

HHSO100200600019C……………….  Emergent Biodefense      BioThrax (Anthrax Vaccine    Yes.

Operations.              Adsorbed, AVA).

HHSO100200700037C……………….  Emergent Biodefense      BioThrax (Anthrax Vaccine    No.

Operations.              Adsorbed, AVA).

W9113M-04-D-0002………………..  BioPort (Emergent        BioThrax (Anthrax Vaccine    Yes.

Biosolutions).           Adsorbed, AVA).

DAMD 17-97-D-00003………………  BioPort (Emergent        BioThrax (Anthrax Vaccine    Yes.

Biosolutions).           Adsorbed, AVA) Shipping.

HHSN 272200700035C………………  Elusys……………..  Anthrax monoclonal           No.

antibody–ETI-204.

HHSN 272200700033C………………  Pharmathene…………  Anthrax monoclonal           No.

antibody–Valortim.

HHSN 272200700034C………………  Emergent BioSolutions..  Anthrax immune globulin–    No.

AIG.

NO1-A1-30052……………………  Avecia (Pharmathene)…  Recombinant protective       No.

antigen (rPA) anthrax

vaccine.

V797P-5777x…………………….  Shering Corp………..  Cipro 250mg/5ml; 100ml       No.

suspension.

V797P-5977x…………………….  Cobalt Pharmaceuticals.  Cipro 500mg tablets……..  No.

V797P-5941x…………………….  Blu Pharmaceuticals….  Doxycycline 100mg tablets..  No.

V797P-5883x…………………….  Pfizer, Inc…………  Doxycycline 25mg/5ml         No.

suspension 60ml.

V797P-5669x…………………….  Abraxis Bioscience, Inc  Doxycycline 100mg vial IV..  No.

V797-DSNS-8002………………….  Sandoz, Inc…………  Amoxicillin 500mg capsules.  No.

V797-DSNS-8002………………….  Sandoz, Inc…………  Amoxicillin 400mg/5ml;       No.

100ml suspension.

V797BPA0015…………………….  Bedford Labs………..  Rifampin 600mg vial IV…..  No.

V797P-5396x…………………….  Hospira…………….  Clindamycin 150mg/ml 6ml     No.

vial IV.

V797P-5669x…………………….  Abraxis Bioscience, Inc  Vancomycin 1 g vial IV…..  No.

V797P-1020x…………………….  McKesson……………  Penicillin GK 20 million     No.

unit vial IV.

V797P-5387x…………………….  Johnson and Johnson      Levofloxacin 5mg/ml 150ml    No.

Healthcare.              bag IV.

—————————————————————————————————————-

* Status of indemnification coverage under P.L. 85-804 (An Act to authorize the making, amendment and

modification of contracts to facilitate the national defense.)

[FR Doc. E8-23547 Filed 10-1-08; 4:15 pm]

BILLING CODE 4150-37-P

PROVE provides information on vaccines, and immunization policies and practices that affect the children and adults of Texas. Our mission is to prevent vaccine injury and death and to promote and protect the right of every person to make informed independent vaccination decisions for themselves and their family.

This information is not to be construed as medical OR legal advice.

Contact Information
http://vaccineinfo.net/contactus.html (web site)

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One thought on “Scary Anthrax Rip off

  1. Do you think that Obama is going to win because the Republicans have such a bad candidate?
    Why did John McCain make his final argument against Obama… coal?
    That’s his closing argument? William Ayers, Rev. Wright, spreading the wealth, Born Alive, meeting dictators without preconditions, etc. all have to take a back seat so that McCain can go to Colorado and New Mexico to talk about coal? Does this more or less explain why he’s going to get his clock cleaned Tuesday?

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