[Senate Hearing 109-193]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 109-193
 
                                [ERRATA]
ROUNDTABLE DISCUSSION: WHEN TERROR STRIKES--PREPARING AN EFFECTIVE AND 
                    IMMEDIATE PUBLIC HEALTH RESPONSE

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

                                HEARING

                               BEFORE THE

                              COMMITTEE ON
                 HEALTH, EDUCATION, LABOR, AND PENSIONS
                          UNITED STATES SENATE

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION

                                   ON

  EXAMINING AN EFFECTIVE AND IMMEDIATE PUBLIC HEALTH RESPONSE IN THE 
                    AFTERMATH OF A TERRORISM ATTACK

                               __________

                             JULY 14, 2005

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions



                    U.S. GOVERNMENT PRINTING OFFICE
28-743                      WASHINGTON : 2007
_____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512ï¿½091800  
Fax: (202) 512ï¿½092250 Mail: Stop SSOP, Washington, DC 20402ï¿½090001

                                 ERRATA

                            S. Hrg. 109-193

Supplemental Prepared Statements of George Barrett and George Conk and 
 Response to Questions by Leah Devlin and Tara O'Toole were submitted 
 for the above referenced publication. The additional material follows.


                          ADDITIONAL MATERIAL

                  Prepared Statement of George Barrett

    Chairman, members of the committee, my name is George 
Barrett, President and CEO of Teva North America.
    First, I wish to thank you for inviting Teva to participate 
in this Roundtable discussion today on such an important topic.
    Teva is a vertically-integrated global pharmaceutical 
company founded in Israel in 1901, and is the second largest 
pharmaceutical manufacturer in the United States based on 
numbers of prescriptions dispensed. Teva North America is 
headquartered in North Wales, Pennsylvania and has United 
States manufacturing facilities located in several States. With 
more than 230 products on the U.S. market, Teva manufactures 
approximately 1 out of every 16 prescriptions dispensed in the 
United States. Additionally, Teva is one of the largest 
producers of anti-infective agents in the United States.
    Teva holds a unique position from which to view the 
bioterrorism discussion. Although Teva is best known as the 
U.S. market's largest generic player, we are also a developer 
and manufacturer of patented, researched-based pharmaceutical 
products--we produce and market the leading pharmaceutical 
product for the treatment of Multiple Sclerosis. Because of our 
dual role, we have a deep appreciation for the fine balance 
between encouraging innovation and ensuring access to 
affordable medicines.
    It is also worth noting that, because our parent company is 
headquartered in Israel, we have a particular familiarity with 
the threat of terrorism and regard today's discussion with the 
utmost seriousness.
    We at Teva share a deep commitment to ensuring that the 
United States is well-prepared to counter a bioterror attack. 
Teva strongly supports initiatives designed to bring more 
rapidly and efficiently produced pharmaceutical products to 
counter a bioterrorism attack. Indeed, we believe that S. 3 and 
S. 975, as introduced this year, contain some commendable and 
workable provisions that provide substantial incentives for 
pharmaceutical companies to respond to the challenge of 
producing needed countermeasure pharmaceutical products. These 
include tax credits, needed product liability relief, and 
direct grants.\1\
---------------------------------------------------------------------------
    \1\ See S. 975, 109th Cong.   311-312, 341 and passim (2005), 
respectively; S. 3, 109th Cong.   151-152, 131-142, and passim 
(2005), respectively.
---------------------------------------------------------------------------

WHAT DO THESE PROMISING PROPOSALS HAVE IN COMMON?

    Broadly speaking, the promising aspects of these 2005 bills 
have four key characteristics in common. Specifically, these 
provisions are (1) transparent, (2) proportional, (3) provide 
linkage between the incentive and the relevant investment, and 
(4) allow continued timely access to affordable generic 
versions of life saving drugs to the people who need them 
most--the sick and the elderly. By transparency, we refer to a 
process which is clear and economically visible and 
predictable. By proportional, we mean the benefits should be 
commensurate with the effort. Any further legislative 
incentives must, in our view, reflect these four key 
characteristics which Congress embraced in Bioshield I.
    Unfortunately, in our view, some of the additional 
incentives proposed in S. 3 and S. 975--specifically the ``wild 
card'' patent term extension provisions, the new patent 
restoration provisions, and the proposed expansion of existing 
regulatory exclusivity periods--fail to reflect these 
characteristics and would erode the carefully crafted balance 
struck by Congress when it passed the Hatch-Waxman amendments. 
The effects of these harmful proposals will be felt by American 
consumers through increased health care costs in the United 
States. More specifically,

     The proposed ``special patent term extension,'' 
commonly referred to as the ``wild card extension,'' would 
extend a patent for up to 2 years on any patent of the drug 
company's choosing--even those products wholly unrelated to any 
bioterrorism countermeasure.\2\ Any proposal of this sort fails 
all four tests in that it lacks transparency, proportionality, 
and linkage, and would delay generic access for potentially 
scores of crucial drug products. The result would be to 
dramatically increase the cost of health care in this country, 
and place the added cost burden disproportionately upon the 
sick and elderly. We urge Congress to reject any wild card 
extension proposal as it moves forward with Bioshield II 
legislation.
---------------------------------------------------------------------------
    \2\ See S. 975,   301(b)(4)(A)(iv), 332; S. 3,  113(d).
---------------------------------------------------------------------------
     The pending bills would also add new patent 
extension restoration incentives.\3\ These proposals also lack 
transparency, linkage, and proportionality, and would, by their 
nature, further delay access to affordable generic drugs. For 
example, the proposed extension mechanisms do not include any 
of the carefully balanced limitations of the current 
pharmaceutical patent term restoration law--specifically the 5-
year cap \4\ on any restoration and the 14-year cap \5\ on the 
total effective patent term after a restoration.\6\ Moreover, 
contrary to existing law, these extensions would give full 
credit for time spent prior to submission of a New Drug 
Application for a product, thus diluting the incentive to 
proceed expeditiously in developing a product for submission to 
FDA for approval.\7\ Thus, this policy could substantially 
increase the costs of pharmaceutical products to consumers and 
both public and private payers. These proposals should also be 
rejected by Congress, but at a minimum must restore carefully 
crafted Hatch-Waxman limitations \4\ \5\ \6\ and would need to 
be substantially reworked to provide clear and direct linkage 
of the extension to the actual development and deployment of 
truly novel countermeasures. Furthermore, the truly novel 
countermeasure should pass two tests: (1) it should be required 
to show clinical superiority to existing countermeasures and 
(2) it is unique, i.e., there is no other practicable 
countermeasure readily available.
---------------------------------------------------------------------------
    \3\ See S. 975,  331(b); S. 3,  113(c).
    \4\ See 35 U.S.C.  156(g)(6)(A) (``If the patent involved was 
issued after the date of enactment of this section, the period of 
extension determined on the basis of the regulatory review period 
determined under any paragraph may not exceed five years.'').
    \5\ See 35 U.S.C.  156(c)(3) (``[T]he period of extension shall be 
reduced so that the total of both such periods does not exceed fourteen 
years.'').
    \6\ See 37 C.F.R.  1.775(d).
    \7\ Compare S. 975,  331(b) (proposing 35 U.S.C.  156a(b) (``The 
term of an eligible patent shall be restored by a period equal to the 
number of days in the regulatory review period[.]'')); and S. 3,  
112(c) (proposing 35 U.S.C.  156a(b)(same)) with 35 U.S.C.  156(c)(2) 
(reducing the period of time eligible for extension based on the review 
of the Investigational New Drug Application to one-half day per day).
---------------------------------------------------------------------------
     One pending bill, S. 975, would, in certain 
circumstances, double the length of the existing 5-year New 
Chemical Entity (``NCE'') exclusivity and the 3-year ``clinical 
trial'' exclusivity, and would expand the 7-year Orphan Drug 
Exclusivity to 10 years.\8\ This proposal is highly 
disproportionate to the effort needed to qualify for these 
extensions, suffers from a lack of transparency, and would 
substantially delay access to affordable medicines. Any 
proposal of this nature should therefore also be rejected.
---------------------------------------------------------------------------
    \8\ See S. 975,  331(e).

    I would like to add that one should look with suspicion at 
any proposal that seeks to use the threat of trade sanctions as 
a way of forcing patent extensions and data exclusivity 
provisions on a non-domestic pharmaceutical producer, which 
would lead to the unintended result of increased pharmaceutical 
prices for American consumers.\9\
---------------------------------------------------------------------------
    \9\ See, e.g., S. 975,  332 (stating that the Secretary of 
Commerce, the United States Trade Representative and the Commissioner 
of Patents shall ensure that ``substantially similar intellectual 
property rights granted to the same or related entities as those that 
qualify for restoration or an extension under such sections are not 
impaired.'').
---------------------------------------------------------------------------
    It is in this context that we regard certain provisions of 
S. 3 and S. 975 as inconsistent with the goal of bringing novel 
countermeasures to the market, while at the same time 
preserving access to affordable medicines. Each of these bills 
contains harmful incentives which disconnect the rewards from 
the investment. As introduced, certain provision of these bills 
would have the unintended effect of delaying generic drugs to 
market and increasing health care costs in the United States.
    Of the annual $235 billion spent in 2004 on prescription 
drugs in the United States, the generic segment accounted for 
only about 10 percent of the costs. This is true, despite the 
fact that over 50 percent of the prescriptions were filled with 
a generic pharmaceutical product. Consumers, businesses, health 
plans, and the Government all benefit from the availability of 
generic pharmaceuticals. Any delay in the flow of generic 
products into the market will have a crippling cost impact on 
American private and public purchasers and a disproportionate 
affect on society's most vulnerable. Clearly, this is a result 
that America can ill-afford at this time.

WHAT APPROACH SHOULD CONGRESS CONSIDER IN PURSUING BIOSHIELD II 
                    LEGISLATION?

    Congress should consider the role of pharmaceutical 
manufacturing in the biodefense effort in the broadest of ways. 
This requires not only that we encourage the development of 
novel treatments with appropriate incentives, but also requires 
that we pay particular attention to procuring the appropriate 
products in the fastest way possible.
    Much of the public discussion has centered around 
encouraging the ``major'' research-based pharmaceutical 
companies to engage in this activity working on 
countermeasures. Yet today, three of the five largest producers 
of pharmaceutical products in the United States are ``generic 
drug'' companies. Another company among the top five has a very 
large generic pharmaceutical division. These are companies with 
enormous productive capacity, multipurpose facilities, and 
extensive distribution operations, and as a result, high 
operational flexibility. Teva alone produces and distributes 
well over 200 generic products for the U.S. market and is one 
of the world's largest producers of anti-infective agents. We 
would encourage you to consider how to mobilize our Nation's 
entire productive capacity to help counter a bioterror threat.
    Legislation should focus more closely on the production, 
procurement, and distribution aspects of a bioterror response 
system. Part of that system should include mechanisms for rapid 
technology transfer to manufacturers where a needed 
countermeasure is in short supply or cannot be produced by the 
company that may be the sole current producer. Companies like 
Teva have the capacity and flexibility to respond to this need 
and can begin producing large quantities of pharmaceuticals on 
short notice. However, the normal regulatory procedures used to 
qualify a new manufacturing site are time consuming, which 
could delay emergency access. Expedited regulatory pathways for 
such manufacturing site changes are necessary to assure rapid 
response to any bioterror attack.
    Congress should, in much the same way it procures military 
equipment in a time of war, establish a direct procurement 
system as part of the defense budget to obtain needed 
pharmaceutical countermeasures. This would build on the work of 
Bioshield I, with companies bidding on contracts to provide 
specifically requested countermeasures at negotiated prices. We 
strongly advise that Congress add a guaranteed stockpile 
purchasing component to this direct procurement system.
    We believe that participation in the cost of clinical 
trials would be the most direct and appropriate incentive to 
encourage the development of novel countermeasures. The risk 
associated with clinical trials is the largest cost a company 
faces in evaluating a pharmaceutical development project. We 
would recommend that Congress include clinical costs in 
procurement contracts. Direct support for clinical trials would 
be a fair and workable system and would help support the goal 
of encouraging the development of countermeasures. Indirect 
subsidies, such as patent/exclusivity extensions, will 
undermine the ultimate objective.
    Finally, we have a policy recommendation to help rapidly 
identify and widely disseminate information on drugs known to 
be effective against many potential bioterror weapons. 
Specifically, a ``Medical Expert Biodefense Task Force'' should 
be established to review data relating to available drugs, 
biologics, antibiotics, and devices that may be effective in 
treating, preventing, identifying, or detecting harm from 
potential bioterror weapons. This information would then be 
used by the Department of Health and Human Services Secretary 
to immediately inform health care prescribers of the currently 
available products that are suitable for treating or responding 
to bioterrorism health threats, thus expediting the range and 
use of treatment options available for health care 
professionals and patients. By reviewing available medical 
literature to identify bioterror pathogens and agents for which 
reliable evidence exists as to the efficacy of existing 
treatments, America's security could be quickly and cost-
effectively enhanced--without the need for unnecessary and cost 
inefficient intellectual property-based incentives.
    Preparing our Nation to respond to a bioterrorism threat 
will not come without a significant Federal investment. It is 
far better, however, to have a direct system of procurement 
paid for out of the defense and homeland security budgets (with 
the burden falling equitably among all Americans), than to 
create a far more expensive and elaborate, loophole-laden 
patent or exclusivity incentive scheme that shifts the cost 
onto the health care system. A direct system would 
successfully, efficiently, and cost-effectively encourage the 
pharmaceutical industry to provide needed countermeasures.
    Teva will continue to support measures which encourage the 
development of novel biodefense countermeasures, among them tax 
incentives related to development and manufacturing, product 
liability relief, research and development grants, guaranteed 
stockpile purchasing, and other approaches as described above. 
Such approaches would be consistent with the essential 
characteristics of transparency, proportionality, and providing 
linkage between the incentive and the relevant investment 
without compromising America's access to affordable medicines 
on a timely basis.
    Finally, Teva is prepared to do its part in this overall 
biodefense effort.
    Thank you, Chairman, members of the committee, for allowing 
Teva to share our thoughts with you today.

                  Prepared Statement of George W. Conk

Introduction

    S. 975, the proposed ``Project BioShield II Act of 2005,'' broadly 
addresses ``biological and chemical agents, toxins, and nuclear and 
radiological materials that may be used as weapons of mass destruction 
or that are infectious diseases with respect to which the Secretary 
finds that research to develop new and improved countermeasures is in 
the national interest of the United States.''
    Biodefense as protection against terrorist attack is properly seen 
as but a part of a comprehensive plan to protect and improve the public 
health system. We cannot say if or when we will be attacked with 
biological weapons. But our experience with HIV and SARS, immigration, 
and international travel enable us to say with certainty that new 
pathogens will present major challenges to our public health system.
    Naturally-occurring biological threats and criminal attacks 
(whether political or otherwise) using biological and other such 
weapons closely overlap in the pathologies inflicted and in the human 
and material resources needed to respond effectively. Biodefense 
against terrorists is but a subset of our overall public health 
preparedness. As the Institute of Medicine said after the recent 
smallpox vaccination campaign: ``Readiness to respond to public health 
emergencies (including smallpox [and other] emergencies) should be part 
of overall continuous quality improvement of the public health 
system.'' \1\
    Our approach to civil liability and victim compensation too should 
generally treat alike compensation issues arising from general public 
health measures and ``biodefense'' against criminal use of pathogenic 
biological agents. We need not overhaul our system of compensation and 
liability--but should adjust it to address specific shortcomings. But 
S. 975 unwisely federalizes a wide swath of our public health system. 
The United States would gratuitously insure a wide swath of industry, 
researchers, hospitals, and health care workers. S. 975 substitutes the 
United States in their stead as defendant in an unknowable number of 
cases, displacing State common law with Federal limits on damages, and 
eliminating the common law right to trial by jury which is preserved in 
every State.
    We rely on three main approaches: tort liability (including product 
liability), workers compensation, and statutory compensation schemes 
for special needs. Among the special needs cases are the childhood 
vaccine compensation program which addresses complications arising from 
mandatory vaccination,\2\ and the smallpox vaccination program in which 
we asked health workers to volunteer to subject themselves to a live 
virus which carried a risk of vaccine-related disease in the 
recipients.\3\ Thirty years ago we enacted a special measure for swine 
flu vaccinees.
    We should adhere to the State law based common law tort system and 
workers compensation as the principal sources of compensation, offering 
out-of the ordinary compensation only exceptionally, such as to those 
who volunteer to subject themselves to extraordinary risks.
    The Federal Government should not gratuitously insure 
``biodefense'' manufacturers, distributors and administrators for their 
negligence. S. 975's broad expansion of such undertakings is 
unwarranted.
    Our priorities in public health defense must be to:

     maximize the health of the American people;
     ensure public confidence that government is making its 
best efforts to protect the health of all who live in, work in, and 
visit America; and
     recognize that public trust requires both candor and 
acceptance of responsibility for error.

The Tort System and Product Liability Law

    One who through his fault causes harm to the person or property of 
another is liable in tort. One who employs a negligent person is 
responsible for the harm caused by the negligence of his/her employee. 
Product liability law has often been described otherwise--as strict or 
even absolute liability. But product liability law has grayed, as 
leading treatise author Prof. David Owen has observed. It is a mature 
body of law which yields generally predictable outcomes.
    The basic propositions of our product liability law are these:

     when products depart from specification and cause injury 
to others the manufacturer of the product bears responsibility for the 
harm caused by its departure from the norm;
     manufacturers must exercise stewardship over their 
products--studying them sufficiently that users and others are given 
sufficient information to use them safely, and to make a reasonable 
assessment of those risks which unavoidably accompany use of a 
worthwhile product; and
     manufacturers are responsible for the harm done by 
negligent design--the unreasonable omission of practical and feasible 
safer alternative designs.

    These principles express deeply embedded normative expectations of 
our citizens. Federal, State and local government, individuals, and 
industry accept similar responsibility for their errors. A heavy burden 
of persuasion therefore should be imposed on those who favor immunity 
or limited liability for designers, manufacturers, researchers, and 
administrators of vaccines and other biological, pharmaceutical, and 
medical products.
    The employer-funded workers compensation system plays a major role 
in protecting health and emergency workers. Injuries arising out of and 
in the course of employment are compensable regardless of fault. Only a 
causal connection between the work and the illness need be shown.
    The tort and workers compensation systems are capable of (and do) 
handling the needs of those injured. They adequately limit the 
liability risks of those who undertake to do the research, develop, and 
deploy the technologies which the Congress seeks to encourage. And they 
do it without relieving actors of liability for their faulty conduct 
and without the Federal Government gratuitously assuming liability for 
harms it did not create.

Free Insurance and Limited Liability

    In the past 25 years I have represented those injured by asbestos 
products and machine sellers who did not exercise reasonable 
stewardship over their products. Tort liability was properly imposed. 
In my representation of hemophiliacs and their families I saw that an 
industry immunized by ``blood shield laws'' escaped liability despite 
its failure to pasteurize blood products which were given to 
hemophiliacs. Nearly every hemophiliac in America, Western Europe, and 
Japan was infected with HIV and/or hepatitis as a result.\4\
    Of the three epidemics the legal system dealt far more justly with 
asbestos and industrial accident than it did with hemophiliacs. I 
therefore view very skeptically those who would shift to the public the 
cost of compensating those who have been injured by a manufacturer's 
negligent (or more egregious) conduct.
    Such a shift would be the result of S. 975. The bill relieves of 
responsibility for their errors manufacturers, distributors, and 
administrators of ``biodefense'' and other public health measures. It 
insures the negligent without charge and offers limited compensation to 
victims of medical and industrial error who can prove fault by the 
immunized in whose place the United States stands. S. 975 is a 
legislative massive expansion of Executive Order 10789 contractual 
indemnification by Government coupled with a thin compensation program 
modeled on the 2003 Smallpox Emergency Personnel Protection Act of 
2003, which amended the Public Health Service Act.\5\
    This expansion of aspects the Smallpox Emergency Personnel Act is 
undertaken without study of its cost. If the cost proves to be small 
and industry's fears are unwarranted, the expansion of Federal 
responsibility is unneeded. If the cost is shown to be large then 
candor and fiscal responsibility require that we make provision for 
that budgetary burden. If we lack adequate information we should not 
act.

False Alarms

    Fears are expressed that incalculable, and impliedly huge, 
liability is faced by ``biodefense'' manufacturers. I believe these 
fears are unwarranted and do not justify the proposed broad expansion 
of the defense, indemnification, and compensation scheme adopted in the 
Smallpox Emergency Act. Nor is it necessary for the United States to 
assume the burden of defending, as it would public health officers in 
its employ, all who ``manufacture, distribute and administer'' 
``biological and chemical agents, toxins, and nuclear and radiological 
materials that may be used as weapons of mass destruction or that are 
infectious diseases with respect to which the Secretary finds that 
research to develop new and improved countermeasures is in the national 
interest of the United States.''
    Last October this committee was warned that ``a test kit for 
Anthrax exposure that may, perhaps, provide false positives would 
expose the manufacturer to tremendous and likely (un)insurable 
liability thereby preventing widespread deployment, even if the 
diagnostic is the current state-of-the-art.'' No such liability risk 
exists.
    HIV tests have recognized rates of false positives. The test is 
therefore administered twice, since consecutive false positives are 
rare. No liability problems have ensued. If by ``state-of-the-art'' one 
means current practice, liability is not categorically ruled out. But a 
legal presumption that FDA approval indicates reasonableness in design 
and warnings is common.\6\ Such a presumption must be rebutted by 
competent evidence that critical safety information was unreasonably 
omitted or not developed, or that a safer alternative design was 
practical, feasible, and unreasonably omitted.
    Others have suggested that those who have obtained approval for 
emergency measures--such as distribution of a biologic that has been 
tested only on animals, and allowed to be distributed as an emergency 
measure, after findings of specific threats at the Secretarial level 
and FDA approval under 21 U.S.C. 360bbb-3 need special protection from 
liability claims. But the law of torts is founded on a determination of 
reasonable risk imposition--and an emergency is an appropriate 
circumstance for taking risks in rescue efforts that otherwise would 
not have been taken.
    In almost every jurisdiction the Second Restatement of Torts  402 
A, comment K would be cited for the proposition that an unavoidably 
unsafe but useful product is not defective if it is administered with 
reasonable care, and the patient is given reasonable notice of the 
dangers presented by the product (either directly or by informing the 
prescribing physician), and the good done by the product exceeds the 
harm it causes. The factual determination of necessity by the Secretary 
of Defense and Secretary of Homeland Security of a specific threat and 
FDA approval of such a product are all powerful indicia of 
reasonableness and necessity. Administration of such emergency 
medications, with adequate advice to recipients, is certainly 
reasonable and therefore is not actionable--under common law tort 
principles.
    It has also been suggested that vaccines which cannot ethically be 
deployed in clinical trials because of their hazards present grave 
liability risks for manufacturers who can test them only on animals and 
therefore may not be able to identify risks to humans. Such limitations 
of evidence are but a factor for the FDA and others to consider in 
determining safety and effectiveness. If such risk is unavoidable for 
ethical or other reasons, then use of such products is reasonable and 
non-actionable. In fact the archetypal example taught to every law 
student is the unavoidable risks of the Pasteur rabies vaccine which 
faced a patient with the choice of risking a horrible death from rabies 
if the animal was rabid, or taking the risk of taking the unavoidably 
unsafe vaccine. Such products are not defective--every law student 
learns.

Who has Potential Claims? How Are They Treated? How Should They Be 
                    Treated?

    Under existing law potential claimants include:
    1. Persons who while in the course of their employment work with 
infectious materials or persons, toxic materials, or devices and who 
suffer illness or injury (such as health workers exposed to HIV or 
tuberculosis). Such workers are entitled to workers compensation 
benefits. And in the case of injury by a defective product, or 
inadequate warning they have a right to bring a third party product 
liability suit. The present system is adequate.
    2. Persons who volunteer to administer vaccines or render medical 
care to others who become ill or suffer injury because of their care 
for others. Such persons are not compensated, except if a fault-based 
tort action is available. Such persons should be compensated either by 
workers compensation or by a no-fault system of compensation such as 
Congress devised for those who administered or received smallpox 
vaccination.
    3. Volunteers who offer to be vaccinated as part of preparation for 
service to others (e.g., medical personnel who volunteered to be 
vaccinated against smallpox). Such volunteers are not compensated 
unless they assumed the risk at the request of their employer and the 
risks arise from the employment. Pure volunteers should be compensated 
via a no-fault system. Common law product liability actions should be 
retained.
    4. Volunteer subjects in clinical trials. No provisions exist for 
compensating such volunteer subjects. Compensation--including medical 
care should be afforded for such persons.
    5. Persons who are compelled to be vaccinated (such as children who 
cannot be admitted to school unless they are vaccinated). Children who 
suffered recognized complications (or provable complications) are 
entitled to be compensated under the National Childhood Vaccine Injury 
Compensation Act of 1986. Persons compelled to take such risks should 
be compensated.
    6. Patients who, to protect their health, are vaccinated 
voluntarily and become sick thereby. Such persons do not receive 
compensation and should not be compensated unless the product was 
defective or the medical advice was unreasonable.
    7. Household members or others who become sick through contact with 
dangerous materials, infected persons, or the like (such as intimate 
contacts of smallpox vaccinees). They are compensated only through tort 
actions--which are generally not available. Even if the physician who 
ordered the vaccination knew of the risk to the household member and 
failed to warn of it, an action is not viable absent a physician-
patient relationship. The extent of the duty of a physician is best 
left to developing common law tort law.

Compensation Choices

    BioShield I immunized smallpox vaccine manufacturers by compelling 
all claims to be made against the United States under the Tort Claims 
Act--allowing recourse against the manufacturer only for gross 
misconduct or contract violation. S. 975 permits (limited only by 
unreviewable administrative fiat) broad expansion of that burden to an 
``initial list'' of 75 agents of disease, and ``(a)ny other new and 
emerging natural infectious disease threats.'' \7\
    Why should the United States, if it chooses to assume such a burden 
as insurer, do so without fee? And why, in any event, should it limit 
its right to recover from its suppliers to instances of breach of 
contract or gross misconduct? Why should the United States--if it 
chooses to compensate citizens for the wrongful conduct of independent 
contractors--not retain the right of recovery from those whose 
negligence or defective products caused injury? In my view the United 
States should not gratuitously insure manufacturers, distributors and 
administrators of defective products and those who act negligently.

Endnotes

1. IOM, Review of CDC Smallpox Vaccination Program Implementation, 
Letter Report 5, January 22, 2004.

2. 42 U.S.C. 300aa-15.

3. 42 U.S.C. 239.

4. B.L. Kroner, et al., HIV-1 Infection Incidence Among Persons with 
Hemophilia in the United States and Western Europe, 1978-1990, Journal 
of Acquired Immune Deficiency Syndromes, 7:279-286 (1994); Institute of 
Medicine of the National Academy of Sciences, HIV AND THE BLOOD SUPPLY, 
National Academy Press (1995).

5. 42 U.S.C.  202.

6. Perez v. Wyeth Lab., 161 N.J. 1 (N.J., 1999).

7. S. 975,  319F-3 (f).

Resources

George W. Conk, Reactions and Overreactions: Smallpox Vaccination, 
Complications, and Compensation, 14 Fordham Environmental Law Journal 
439 (2003).

George W. Conk, Is There a Design Defect in the Restatement of Torts: 
Products Liability?, 109 Yale L.J. 1087 (2000), and George W. Conk, The 
True Test: Alternative Safer Designs for Drugs and Medical Devices in a 
Patent-Constrained Market, 49 UCLA L. Rev. 737 (2002) (arguing that 
drugs, vaccines, blood products, and medical devices are amenable to 
the alternative safer design test of product defect embraced by Section 
2 of the Products Liability Restatement, [ALI 1998] and rejecting the 
Restatement's Section 6(c) which rejected such a comparative test, 
permitting liability findings only where the sum of the harms done by 
the product exceed its benefits for every class of user); but see James 
A. Henderson, Jr., and Aaron D. Twerski, Drug Designs Are Different, 
111 Yale L.J. 151 (2001) (acknowledging the aptness of testing by 
alternative designs, but limiting the comparison to products already 
approved by the U.S. Food and Drug Administration and actually 
available on the market at the time of sale of the challenged product).

Comment K and defense of Drug Product Design Claims:

Some courts have construed Restatement of Torts, 2d,  402A, comment k 
to be a rule of virtual immunity for drugs, which are presumed to carry 
risks that are unavoidable. See, e.g., Brown v. Superior Court (Abbott 
Labs.), 751 P.2d 470 (Cal. 1988); Grundberg v. Upjohn Co., 813 P.2d 89 
(Utah 1991); Young v. Key Pharms., 922 P.2d 59 (Wisc. 1996) (en banc).

Support for the Brown approach appears to be eroding. See, e.g., 
Freeman v. Hoffman LaRoche, 618 N.W. 2d 827 (Neb. 2000) (Supreme Court 
overrules McDaniel v. McNeil Labs. Inc., 241 N.W.2d 822 (Neb. 1976), 
and rejects its previous adherence to the minority view that a properly 
manufactured drug accompanied by an adequate warning of the risks known 
to the manufacturer at the time of sale is not defectively designed as 
a matter of law). Accord: Bryant v. Hoffman La Roche, 2003 Georgia 
Lexis 945 (Ga. Ct. App.).

The Nebraska court now embraces the ``majority rule'' that applies the 
comment k defense on a case-by-case basis, believing that societal 
interests in ensuring the marketing and development of prescription 
drugs will be adequately served without the need to resort to a rule of 
blanket immunity. See, e.g., Tobin v. Astra Pharm. Prods., Inc., 993 
F.2d 528 (6th Cir. 1993); Hill v. Searle Labs., 884 F.2d 1064 (8th Cir. 
1989); Belle Bonfils Mem'l Blood Bank v. Hansen, 665 P.2d 118 (Colo. 
1983) (superseded by statute in regard to blood banks, as recognized in 
United Blood Servs. v. Quintana, 827 P.2d 509 (Colo. 1992)); Ortho 
Pharm. Corp. v. Heath, 722 P.2d 410 (Colo. 1986), overruled on other 
grounds by Armentrout v. FMC Corp., 842 P.2d 175 (Colo. 1992); Toner v. 
Lederle Labs., 732 P.2d 297 (Ida. 1987); Feldman v. Lederle Labs, 479 
A.2d 374 (N.J. 1984); Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 
775 (R.I. 1988).

The Third Restatement of Torts, Product Liability,  6 (c) holds that 
design defect claims can be brought against prescription drug and 
medical device manufacturers only if the drug provides no ``net 
benefit'' to any class of users.

The Restatement (Third) of Torts: Products Liability,  2 (b) provides 
that a product is defective if a ``reasonable alternative'' safer 
design was ``unreasonably omitted.''
         Response to Questions of the Committee by Leah Devlin
    An important role for the Federal Government is to work 
collaboratively to assure a stable, predictable market for biodefense 
medical countermeasures and to address related liability issues. Public 
health, with an adequately built and maintained infrastructure, can 
then guarantee timely distribution of these countermeasures to 
ultimately protect the American population from preventable illness and 
death.
    The three main strategies needed to maintain a robust public health 
infrastructure are a commitment to an all hazards approach, a trained 
workforce, and sustainable funding. These three factors, commitment, 
people and resources, will see the Nation into a safer, more protected, 
and better-prepared future.
    The multiple agencies and industries involved in the food chain 
must integrate and coordinate their surveillance, risk vulnerability, 
and mitigation plans. Human health, livestock and crop protection must 
be viewed as a single system for the development of surveillance 
systems, standardized plans, and training for local, State, Federal, 
and industry stakeholders.

    Question 1. What additional incentives or other measures will 
ensure the timely availability of sufficient amounts of effective 
biodefense medical countermeasures, and is the cost of such incentives 
acceptable?
    Answer 1. Biodefense medical countermeasures are one essential 
component of an effective preparedness and response effort which must 
also include surveillance, early detection, quarantine, isolation, 
distribution of biodefense medical countermeasures including mass 
vaccination, mass care and public communications. Having said this, at 
this critical point in history, the alignment of incentives in the 
production of biodefense medical countermeasures (mainly vaccines and 
anti-infective drugs) must hinge on the ability of Government, 
business, and public health to adequately plan together for these 
exigencies. This fundamental concept will be articulated using the 
examples of pandemic influenza, a natural event, and the dispersal of 
anthrax spores, a deliberate event.
    An influenza pandemic occurs when a new influenza virus appears 
against which the human population has no immunity, resulting in 
simultaneous epidemics worldwide with enormous numbers of deaths and 
illness. Because of the ongoing and unprecedented spread of highly 
pathogenic avian influenza type H5N1 in SE Asia, the global alarm for 
the next human influenza pandemic has been sounded by the WHO. The toll 
in the United States using a mid-point estimate of a 25 percent attack 
rate and a 5 percent mortality rate would result in 3 million deaths 
and 10 million hospitalizations, 10 to 100-fold greater than the 
numbers experienced during a typical wintertime flu season. Presently, 
the only biodefense countermeasure for an H5 pandemic influenza of 
avian origin from SE Asia is the single antiviral drug, oseltamivir 
(Tamiflu). The U.S. Strategic National Stockpile contains only a small 
fraction of the oseltamivir needed to protect the U.S. population. 
Using current biotechnology, it would take 12-18 months into the 
pandemic for a suitable vaccine, the ideal biodefense countermeasure, 
to be developed, scaled-up, and delivered.
    In October 2001, the United States fell victim to a bioterrorist 
attack using weaponized anthrax spores. This limited attack on the U.S. 
mail system resulted in 23 cases and 6 fatalities. A terrorist release 
of anthrax spores delivered from a small airplane upwind of a city of 1 
million inhabitants could result in 125,000 cases and 95,000 
fatalities, the first cases arising within 3 days and as long as 2 
months following dispersal. The ideal biodefense countermeasure is 
early detection allowing a rapid public health response including 
delivery of protective antibiotics or vaccination to the exposed 
population. Ironically, supplying and delivering protective antibiotics 
and/or vaccine to a large population at risk within the 3-day 
incubation period for anthrax would be difficult without sustained 
investment in the public health infrastructure.
    These two natural and deliberate infectious disease disasters are 
not far-fetched scenarios. The natural history of humankind predicts 2-
3 influenza pandemics every century and the events of 2001 showed that 
our Nation is vulnerable to an anthrax attack. What incentives, then, 
are required at an acceptable cost that will ensure timely, sufficient 
and effective biodefense countermeasures? Planning among Government, 
business, and public partners is essential to assure a stable, 
predictable market for biodefense medical countermeasures and to 
address related liability concerns.
    In last year's influenza season, the collaboration between industry 
and Government was commendable. It is vitally important when vaccines 
or other countermeasures are in short supply and the need is great that 
the Federal Government and industry work together through the State and 
local public health infrastructure to assure maximum health protection 
for the public.

    Question 2. What is necessary to build and maintain a robust 
national public health infrastructure to meet future biodefense 
requirements?
    Answer 2. Prior to 9/11 public health's preparedness efforts had 
been focused on time-honored communicable diseases and traditional 
investigation strategies as well as responding to natural disasters 
such as hurricanes to the extent possible. Many times an effective 
public health response meant dropping everything else from infant 
mortality reduction efforts to the prevention strategies targeting 
chronic diseases, the leading causes of death, just to get through the 
outbreak or natural disaster.
    After 9/11, public health was fully recognized for the first time 
for its critical role as a first responder, a vital part of the 
community's response to an intentional or unintentional chemical, 
biological, radiological, nuclear or explosive (BCRNE) attack. The new 
normal for public health is that preparedness is a core function. The 
States have a central role in assuring that every county and every 
local health department are prepared to respond effectively. It is 
critical to recognize that ALL emergencies will be identified and first 
responded to on a local level and that the State will mount a multi-
county or statewide effort to support this initially local response. 
The Federal Government comes in to assist the States as needed. This 
coordinated local, State and Federal public health response represents 
one system in responding effectively to any event that threatens the 
public's health. And clearly critical, new partnerships have been 
created between public health and agriculture, law enforcement, 
emergency management, emergency medical services, other first 
responders of all types and other medical providers in order to have 
the greatest impact. These partnerships with public health have become 
institutionalized and are absolutely critical to saving lives in every 
community in the Nation.
    The top three priorities to maintain a robust national public 
health infrastructure are to:
    1. Focus on All Hazards--but at the same time remember that public 
health is much broader than preparedness.
    2. Assure a workforce that has the expertise to respond effectively 
in a world of new challenges--S. 506 (Hagle/Durbin) bill should be 
passed.
    3. Sustain a national commitment to the Federal preparedness 
cooperative agreement funding which is absolutely essential for States 
and communities to be able to respond to such health threats as West 
Nile virus, SARS, hurricanes or pandemic influenza. Now is exactly NOT 
the time to cut Federal preparedness funding to States and communities.
    In regard to an all hazards approach, North Carolina's chemical, 
biological, radiological, nuclear and explosive vulnerabilities have 
all been assessed. On that basis, the State developed seven regional 
response teams to cover the entire State. These teams are comprised of 
a physician, nurse epidemiologist, industrial hygienists and management 
support. All seven include a relationship with a veterinarian from 
Agriculture and three teams include a pharmacist and new lab capacity. 
The seven teams along with the State Preparedness and Response Team and 
the 85 local health departments implement the functional components of 
the NC Public Health Preparedness and Response Plan. This Plan includes 
strategies on surveillance, disease investigation, vaccination/
prophylaxis, quarantine and isolation, mass care, mass fatality, public 
communications and command/control/communications. Every aspect of the 
plan is supported by critical technology systems, which are in varying 
stages of development or implementation. The importance of technology 
in saving lives cannot be underestimated. Also, the training of the 
workforce who must implement every aspect of the plan cannot be 
underestimated. These two issues--technology and workforce 
preparedness--are absolutely essential to effectively deploying North 
Carolina's Preparedness Plan and saving lives. This type of 
preparedness must be done ``pre-event'' and must include continually 
exercising and improving these plans.
    Specifically, in regard to workforce preparedness, within the new 
public health infrastructure that has been built with Federal support, 
there are 70 Bioterrorism Planners, 7 regional surveillance teams, 12 
public health epidemiologists deployed to the largest hospitals in the 
State and the local public health workforce of the counties. As 
important as the development of new vaccines is, as critical as the 
rapid deployment of the Strategic National Stockpile (SNS) is, if there 
is not an adequately trained workforce on the ground ready to disperse 
these medical interventions in a timely and appropriate manner then 
there is no point in having SNS to begin with. The passage of S. 506 
(Hagle/Durbin) is critically important. This bill will provide for 
scholarships and loan repayment for students entering the governmental 
public health workforce, an important first step in addressing the 
current workforce crisis in public health at a time when the challenges 
are greater than ever before.
    Sustaining the Federal resources is essential. The States are doing 
an outstanding job of using these funds to build the public health 
infrastructure--collectively 90 percent of the States have obligated or 
spent their 2003 funds and 90 percent have spent or obligated the 
hospital preparedness funds, States have spent 98 percent of the CDC 
preparedness funds in 2003. There are at least 5 benchmarks that have 
been developed to measure accountability by various Federal or national 
agencies on the use of these funds. Consensus is needed on which 
indicators measure the entire system's ability to perform in an event. 
North Carolina has been successfully audited three times on the use of 
the CDC and the HRSA funding. It is important to note that the public 
continues to expect more and more protection from the local, State and 
Federal public health system. Sustaining Federal resources is the only 
way to meet that expectation. The challenges are increasing as well--
the best current example being the potential for pandemic flu, which 
will overwhelm existing infrastructure.
    Real life experiences are what count. Since 9/11 and the 
development of this new public health infrastructure, North Carolina 
has had some dramatic preparedness and response challenges. These 
include SARS, the smallpox immunization plan, numerous hurricanes, the 
vaccine flu shortage, a major outbreak of E coli, an unusual outbreak 
of legionnaire's disease, numerous white powder incidents and various 
infections that could have represented a bioterrorism event. North 
Carolina has also staged a number of large exercises based on main 
public events involving a chemical release or the plague and other 
exercises on food security or avian influenza. In every instance, the 
partnerships with law enforcement, agriculture, other first responders 
and providers have been essential.

    Question 3. What is necessary to protect our food supply and 
agriculture from biodefense threats?
    Answer 3. If 9/11 has taught the Nation anything, it is that it can 
no longer approach surveillance, early detection, mitigation, response 
and recovery in a fragmented way. The days of a silo division of 
agencies needs to be replaced with a unified approach to protecting the 
food chain--from the farm to the fork. Public health must join forces 
with Department of Agriculture, FDA, EPA and industry to address 
biodefense concerns.
    First, each State should improve communication and coordination 
between all regulatory/advisory agencies and private industry. Threat 
intelligence must be shared with industry so they can determine 
vulnerability.
    Secondly, States, using standardized criteria, must assess the 
vulnerabilities of the food and agriculture chain using a valid 
vulnerability assessment tool, such as CARVER + Shock. The data must 
then be assessed and shared with all States and industry as appropriate 
to enable the system to be strengthened in accordance with the current 
level of threat.
    Third, States must also improve their ability to conduct active 
surveillance and detection of pathogens or contaminants by improving 
connectivity and interoperability among all key stakeholders. This is 
essential for responding to all hazard events related to livestock, 
plants, food and humans. To do this States, as well as the Federal 
Government, must develop multi-hazard threat databases in which all 
vulnerability and surveillance data is placed. Accessibly to this 
database must be provided to appropriate law enforcement, emergency 
response, agriculture, and public health officials.
    Underlying this cooperative work between Government and industry is 
the development of specific mitigation response, and recovery plans 
designed to reduce the overall effects and impact from any terrorist 
act targeting the State's food and agriculture systems. Reasonable and 
cost effective vulnerability/risk reduction plans tailored to the key 
sectors of States' food and agriculture chains that are integrated 
within each industry component and supported by law enforcement and 
security community agencies need to be developed. These plans must 
include local and State standards in conjunction with national standard 
for food and agriculture security.
    State leadership in shaping Government policy on food defense and 
dissemination of current information on Government affairs and issues 
must be coordinated with other States and Federal Agencies.
    It is critical to assimilate and develop training curricula for key 
stakeholders. An institutionalized program of food and agriculture 
defense and response training and exercises to better prepare emergency 
response teams at the State and local levels, along with integrated 
industry training and exercises, are needed to protect the States' food 
and agriculture chain.
    In summary, the multiple agencies and industries involved in the 
food chain must integrate and coordinate their surveillance, risk 
vulnerability, and mitigation plans. Human health, livestock and crop 
protection must be viewed as a single system for the development of 
surveillance systems, standardized plans, and training for local, 
State, Federal, and industry stakeholders.
   Response to Questions of the Committee by Tara O'Toole, M.D., MPH
                            Center for Biosecurity,
            University of Pittsburg Medical Center,
                                       Baltimore, MD 21202,
                                                     July 12, 2005.
Hon. Richard Burr,
Chairman,
Subcommittee on Bioterrorism and Public Health Preparedness,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, D.C. 20510.
Hon. Edward Kennedy,
Ranking Member,
Subcommittee on Bioterrorism and Public Health Preparedness,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, D.C. 20510.

    Dear Chairman Burr and Senator Kennedy: Thank you for the 
opportunity to participate in the July 14, 2005 Roundtable entitled 
``When Terror Strikes--Preparing an Effective and Immediate Public 
Health Response,'' sponsored by the U.S. Senate Committee on Health, 
Education, Labor, and Pensions, Subcommittee on Bioterrorism and Public 
Health Preparedness. Your continued, bi-partisan leadership on these 
critical issues of national security is to be commended. I am pleased 
to respond to the subcommittee's written questions.
    Each of the three questions addresses critical aspects of 
biosecurity. There has been some modest progress in each of these areas 
in recent years, but in spite of earnest efforts by many hard working 
Government officials, the Nation remains largely incapable of 
mitigating the consequences of a serious bioterrorist attack, or 
campaign of attacks or of marshalling a coherent response to a natural 
pandemic. The disappointing pace of advancement is due in part to the 
technical and managerial challenges involved.
    More significantly, the strategic significance and urgency of the 
biothreat has not been grasped or conveyed in ways that make possible 
the political and budgetary sea changes needed to establish the 
priorities and policies and build the new systems we will need--both in 
the United States and internationally--to mitigate the death, suffering 
and social and economic disruption that will come in the wake of a 
large, lethal and fast-moving epidemic designed and perpetrated by a 
thinking enemy or by mother nature.
    There is a pressing need to develop a long-term U.S. biosecurity 
strategy, a ``vision of victory'' which would, if implemented, afford 
the Nation protection against destabilizing epidemics. This will 
necessarily be a long-term project given the complexities of the threat 
and the scope of the systems we must prepare and build. In my written 
comments, I will try to address both strategic goals and more tactical, 
near-term priorities.

    Question 1. What additional incentives or other measures will 
ensure timely availability of sufficient amounts of effective 
biodefense medical countermeasures, and is the cost of such incentives 
acceptable?
    Answer 1. The United States should establish the strategic goal of 
radical accelerating the development of vaccines and medicines for the 
prevention and treatment of infectious disease as a top national 
security priority. If the current timeline of countermeasure 
development is maintained (approximately 10 years for small molecule 
drugs and 7 for biologicals), the country cannot possibly afford to 
maintain anything resembling an adequate national stockpile of critical 
therapeutics against the array of potential bioweapons, nor will we 
have the capacity to ``surge'' production of needed medicines and 
vaccines in times of crisis, because the cost of maintaining adequate 
``warm base'' production capacity will prove prohibitive. Furthermore, 
the threat of bioengineered weapons--and the age of such weapons is 
upon us, not a futuristic fantasy--will require the ability to rapidly 
create countermeasures to unanticipated pathogens.
    The extraordinary advances in biological science that are now 
underway is such that the goal of radical acceleration of drug 
development is an ambitious, but plausible project, with huge payoffs 
for reducing the costs of health care, spurring medical innovation and 
addressing the burden of infectious disease in the developing world. 
Such a goal would require a sustained commitment on the part of the 
U.S. Government as well as innovative leadership, but is, in my view, 
absolutely essential to U.S. national security.

Tactical, Near-Term Goals

    Consider new funding approaches to support the near-term 
development of specific countermeasures and to promote the strategic 
goal of accelerating drug and vaccine development generally. More 
specifically, Congress could consider:

     Funding mechanisms to support the early development phase 
of countermeasures (the ``valley of death'').
     Creation of a ``BioDARPA'' that would invest in 
transformational bioresearch. Such research would be ``project driven'' 
and linked to identified national needs.
     Exploring ways to encourage the biopharma industry to 
invest in anti-infective R&D and to pursue accelerated drug 
development. It is important to understand that the biopharma industry 
is abandoning anti-infective R&D generally--new antibiotics and 
antivirals and new vaccines are simply not popular investments because 
they do not produce returns on investments comparable to other drugs. 
These financial realities, the growing problem of antibiotic 
resistance, and the enormous burden that premature mortality due to 
infectious disease levies upon the developing world are going to 
require that governments develop innovative approaches to anti-
infective medicines and vaccines, quite apart from the imperative of 
creating countermeasures against biological weapons. The Sementech 
model that was used to ensure U.S. capacity to manufacture essential 
microchips may be worth examining, as are suggested schemes for 
creating guaranteed markets for certain vaccines etc. [See, for 
example, ``Making Markets for Vaccines--Ideas to Action,'' Center for 
Global Development, 2005.]
     Fixing the liability problem now. Most companies will not 
even consider countermeasure development unless they are shielded from 
the potential risk associated with a vaccine or medicine that cannot be 
tested in large clinical trials and may be used for the first time on 
large, heterogeneous populations in time of grave medical need. How and 
whether liability concerns are handled in Biosheild II will be 
interpreted by the industry as a bellwether of the Government's 
commitment to securing effective countermeasures and will be seen by 
the public as a signal of the Government's faith in these products. 
Some federally backed compensation scheme to protect patients injured 
by countermeasures found faulty (through causes other than negligence) 
should also be enacted.
     Reviewing and clarifying the HHS/DHS process for declaring 
a material threat and deciding what to purchase with Bioshield funds. 
The current process is mysterious, disjointed, slow and inefficient. 
``Splitting the baby'' between DHS and HHS seems unnecessarily 
complicated, is causing long delays and discouraging private sector 
participation. Red teams or some other oversight of the threat 
assessment process and of HHS Bioshield acquisition process should be 
instituted. Expert users (e.g., experienced clinicians and hospital 
administrators) should have a role in determining stockpile 
ingredients. Agencies must be assigned appropriate resources and 
expertise to manage these important programs and it should be clear 
which executive branch programs and political appointees are 
accountable for progress. Without a coherent and fairly transparent 
process for assessing threats and determining Government investments, 
biopharma will not invest in countermeasure R&D and the public will not 
be persuaded that public funds are being well used.
     Incentives to spur investments in the development of anti-
infective medicines and vaccines are almost certain to be an essential 
component of an effective biodefense. I do not think it is possible to 
produce the countermeasures needed to protect the country without the 
active participation of the biopharma industry--they are the ones who 
know how to make drugs. The cost of effective incentives will be high. 
If such incentives are seen as an indirect tax on health care, or are 
extracted from the already inadequate HHS and DHS budgets, they are 
likely to be unpopular with much of the public. One possible approach 
to allaying such anxiety is to ``take'' funds for countermeasure 
incentives from the DOD budget--any zero sum budget calculations could 
be traded against other national defense purchases, not extracted from 
vital, highly pressured health care budgets. Eventually, it will be 
necessary to recognize that funding countermeasure development--and 
most of the Nation's biodefense needs--must be accounted for as 
essential national security investments. It is unlikely that the scope 
of investments and scale of new systems that will be needed to achieve 
biosecurity can be marshaled unless and until such expenditures of 
talent and treasure are recognized as central to the Nation's security. 
The question is whether the country will reach this recognition before 
a destabilizing attack or natural pandemic occurs. The record of 
achievement in preparing for pandemic influenza is not encouraging.

    Question 2. What is necessary to build and maintain a robust 
national public health infrastructure to meet future biodefense 
requirements?
    Answer 2. For the past 4 years, the United States has spent 
approximately $1B annually on improving ``public health preparedness.'' 
By all accounts, progress has been modest. Here too, there is a need 
for a strategic vision of what capacities we are trying to build, a 
clear sense of priorities, and a coherent approach to match Federal 
investments with realistic costs. It is essential to reduce the current 
confusion about which Federal Agency is in charge and to ensure that 
the accountable Federal and State offices have the resources and 
technical staff sufficient to manage the programs under their purview.
    It would be useful to clarify the notion of ``public health 
preparedness'' by specifically identifying a few critical epidemic 
response capacities and considering how these might be best achieved. 
The preparedness demands imposed upon State and local public health 
departments, and upon CDC, have proven unrealistically ambitious given 
the resources made available and the often competing priorities of 
Governors and local officials. I offer the following suggestions for 
your consideration:

Realistically Assess the Existing Limitations of Public Health 
                    Agencies; Acknowledge the Scope of What We Must Do

    For the most part, the 5,000 different ``public health agencies'' 
do not spend much time or resources on the type of tasks that will be 
essential to responding to bioterrorism or to natural epidemics. This 
is not a criticism, it is simply reality: large scale outbreaks of 
infectious disease have not been a big problem in the past 50 years. It 
will not be possible to create the ``necessary infrastructure'' of 
epidemic management by tweaking or upgrading current structures. The 
Nation is going to have to build whole new systems to manage epidemics. 
The sooner this is recognized and we start to plan these systems and 
establish priorities the less time and money will be wasted, the sooner 
we will begin to have a rudimentary response capacity and the more 
likely it will be that such investments reap peacetime, ``dual-use'' 
benefits.

Epidemiological Analysis; Advice to Decisionmakers; Communication With 
                    the Public

    No entity other than governmental public health agencies is likely 
to have the authorities or access needed to collect and analyze 
information essential to managing a large, fast-moving epidemic. At 
present, few agencies have the necessary talent or the tools or the 
training to fulfill these critical tasks, upon which will depend all 
decisionmaking from the local level to the national command authority. 
Communicating with the public is also a task that must be fulfilled or 
greatly aided by public health officials. It may make sense to assign a 
high priority to ensuring that all State health agencies meet certain 
standards of personnel training and are equipped with adequate 
information management systems and tools to carryout these critical 
functions.
Invest in Training and Credentialing of Public Health Officials
    It is important that any such training be appropriately focused. 
The current emphasis within most schools of public health is on 
research techniques, not public health practice. For training 
investments to pay off there would have to be a new commitment to 
``professionalizing'' public health training. It would make sense to 
make Government service a condition of support for individuals 
participating in such programs and to require participating schools of 
medicine and public health to develop the appropriate curricula and 
practicum experiences.
Build the Electronic Information Systems Necessary to Ensure 
        Situational Awareness During Epidemics
    Creating a national electronic health network within the medical 
care community is an essential component of a robust public health 
information network. President Bush has cited such systems as a highly 
desirable goal to improve medical care quality and to reduce health 
care costs--but current plans call for implementing such systems over 
the next decade, with minimal Federal investments. The United States 
should make the implementation of an integrated electronic health 
information highway a top national security priority and commit to 
having such a system in place within the next 5 years. In the near-
term, consideration should be given to how outbreak management 
``modules'' of a comprehensive medical and public health information 
system might be designed and piloted, with the goal of implementing 
such modules in all States within 3 years.
    There is a well-recognized and urgent need to build the electronic 
information systems needed to manage large disease outbreaks. No public 
health agency has the know-how or resources to design and implement 
such systems on their own, nor does CDC have this expertise. Such a 
project must be driven by the Federal Government with significant 
support from the private sector and from the user communities. 
Functionally, such systems must link health care providers--hospitals, 
clinics, HMOs and individual clinicians--with public health agencies. 
Public health authorities must have the capacity to rapidly collect and 
analyze data from multiple sources--especially from the health delivery 
organizations and from clinicians--in near-real time and to interpret 
such information for clinicians, the public and elected officials.

Protecting the Well: Mass Prophylaxis, Mass Immunization

    A key provision to any solution to the problem of achieving rapid 
distribution of drugs and vaccines to large populations in time of 
crisis is the active support of the Nation's Governors and Mayors. They 
must embrace the importance and urgency of this difficult task and be 
willing to expend the personal time and attention needed to bring 
together parties within their own jurisdictions and to broker regional 
solutions. Anything Congress or the Administration can do to signal and 
emphasize the importance of such leadership would be useful.
    It could be useful to ``unload'' some of the burden from public 
health agencies by assigning more operational responsibilities to the 
health care organizations and other organizations in the private 
sector. Hospitals and HMOs generally have more institutional capacity--
more people, more resources, more administrative skills, more agility--
than most public health agencies, in spite of the problems and 
financial pressures which besiege the health care delivery sector. 
Moreover, dispensing drugs and giving injections is what hospitals and 
health care delivery companies do every day. Many State plans call for 
massive recruitment of local health care providers to implement mass 
prophylaxis or mass vaccination. It may make sense to devise incentives 
or to obligate all or some hospitals and HMOs to take a more proactive 
leadership role in planning and executing such activities. For such an 
approach to work, it would be essential to provide appropriate 
compensation to the participating health care organizations.
    Also, many supermarkets, pharmacies and wholesale discounters 
(e.g., Costco, etc.) routinely deliver flu shots and other 
immunizations. Research by Onora Lien and others at the Center for 
Biosecurity has shown that these companies cover a huge population 
nationally, are in every neighborhood, maintain the infrastructure 
needed (parking lots, electronic registration systems, registered 
pharmacists and nurses) to attend to large populations, and are willing 
and eager to help deliver care in times of emergency. Such innovative 
approaches should be aggressively explored. It is hard to imagine this 
happening unless such responsibility is clearly assigned within the 
Federal Agencies.

Care of the Sick During Epidemics

    Care of the sick in the wake of a bioattack or natural epidemic is 
obviously key to mitigating death and suffering and to communities' 
ability to recover. Inexplicably, this aspect of bioterrorism response 
has been badly neglected. The monies and Federal staff resources 
dedicated to hospital preparedness are minimal and progress is even 
more limited than in the public health arena. It is unclear if HHS or 
DHS is responsible for this sector, there is no identifiable political 
appointee in charge and there have been few efforts to reach out to 
hospital or clinical leaders and professional groups.
    The roles and expected response capacities of the medical sector 
must be examined and clarified. It is impossible to imagine any 
effective mass casualty response that is not organized on a regional 
basis, yet there is no ``organizing authority'' charged with creating 
such regional collaboration or coordination. Here again, Governors and 
Mayors could play key roles, as could some major academic medical 
centers and professional organizations. My colleagues and I would be 
happy to provide more specific thoughts on medical preparedness if this 
would be helpful.

    Question 3. What is necessary to protect our food supply and 
agriculture from biodefense threats?

Government Must Exercise--and Be Seen to Play--the Role of Honest and 
                    Reliable Protector of the United States Food Supply

    Answer 3. An attack on agriculture or the food supply could have 
significant economic and psychological consequences, but is not likely 
to be a strategically destabilizing event. The consequences of such an 
attack would depend greatly on the Government's response. To that end, 
it is imperative that the U.S. Government be seen as an honest broker 
in these matters. The recent handling of reports of BSE in American 
cattle--at least as is portrayed in the press and in professional 
journals--is sending the signal that the Government may not be telling 
the truth in a timely fashion. Such impressions could reap a harsh 
reward if the Government finds itself in the position of trying to 
persuade citizens and international consumers that the danger from a 
real attack are over or contained. Scientifically based surveillance 
systems are essential to ensure the safety of the food supply and the 
financial competitiveness of U.S. agriculture. Such systems should be 
developed and deployed now. This will require the USDA assuming an 
active oversight role and being seen as a reliable overseer by the 
public.

We Need a Plan for Responding to the Most Likely Scenarios

    Much was learned from the 1999 outbreak of FMD in the UK, but it is 
not clear that these lessons have been incorporated into U.S. response 
plans. Roger Breeze has presented a serious proposal that might greatly 
limit the adverse consequences of an attack using foot and mouth 
disease. This plan and other alternatives should be critically examined 
and red-teamed.
    Thank you for this opportunity to respond to the committee's 
questions. I look forward to working with you and your staffs on these 
important issues.
            Yours truly,
                                     Tara O'Toole, MD, MPH,
                                                  CEO and Director,
                                    Center for Biosecurity of UPMC,
                                             Professor of Medicine,
                                          University of Pittsburgh.

                                 

