[Congressional Record (Bound Edition), Volume 151 (2005), Part 4]
[Senate]
[Pages 5810-5813]
[From the U.S. Government Publishing Office, www.gpo.gov]




                      THREAT OF BIOLOGICAL ATTACKS

  Mr. GREGG. Mr. President, I appreciate the courtesy of the Members 
who are in the Chamber and who are dealing with the State Department 
authorization bill and allowing me to proceed as in morning business as 
they address the issues surrounding that bill.
  I wanted to raise an issue which I believe is of very high 
significance of how we deal with the threat of biological attacks. This 
has been an issue I have been involved in for a considerable amount of 
time, having authored the first bioshield bill as the chairman of the 
HELP Committee at the time.
  Just weeks after September 11, anthrax attacks occurred in Florida, 
New York, and Washington. They killed five people, and they crippled 
the mail delivery system in several cities and required a cleanup that 
cost more than $1 billion. For all that, the President's Commission 
which just reported on weapons of mass destruction says we were lucky.
  We cannot really know whether we were exclusively lucky or whether 
this was the result of responsible effort to prepare ourselves for the 
next attack that we have not been attacked again or in a worse way, but 
the facts remain that the threat continues. The President's Commission 
makes obvious the finding that biological weapons are cheaper and 
easier to acquire than nuclear weapons, and they could be even more 
deadly.
  There is no question that if terrorists are able to get their hands 
on a weaponized biological agent, whether it is anthrax, small pox, 
botulism, or ebola, they will use it in a place where Americans gather 
in their daily lives. Whether it is a subway system as occurred in 
Japan or a building as occurred in the Capitol, it is these types of 
attacks--biological, chemical, and dirty bombs--that pose the greatest 
threat to our Nation.
  The President's Commission, which released its report last Thursday, 
exposed the stark reality that our intelligence community may have 
underestimated the progress of terrorists and others in developing 
biological weapons. For example, in Afghanistan, investigators found 
evidence that after the war, al-Qaida had the capability to produce a 
virulent biological weapon identified only as ``agent X,'' which 
documents suggest was anthrax.
  Much of the information we have on the development of biological 
weapons by terrorist groups and rogue nations is classified; however, 
it is no secret that Soviet scientists were working on engineering 
biological agents before the fall of the Soviet Union, including 
smallpox engineered to be totally lethal, a hybrid plague that is more 
resistant to vaccine, and a strain of anthrax resistant to seven 
different antibodies. Unfortunately, we have no assurance that all of 
these products which they were trying to develop have been destroyed. 
We are aware of some rogue countries that developed delivery systems 
such as anthrax-laced cigarettes and botulism-contaminated beer.
  While the President's Commission finds the threat deeply troubling 
today, they foretell that it will be more tomorrow, when genetics 
modification techniques will allow creation of even worse biological 
weapons. These findings underscore that the threat posed to our 
national security from biological, chemical, radiological, and nuclear 
weapons is truly real and significant.
  Even before the anthrax attacks here, we as a Congress recognized the 
need to enhance three critical enterprises or sectors in our country to 
better protect our people from attacks by biological agents: No. 1 the 
research enterprise, led by NIH and private researchers; No. 2 the 
biotechnology development and manufacturing sector, particularly 
vaccines but also other countermeasures such as drugs and devices; and 
No. 3 the broader health care delivery system, including physicians, 
hospitals, and public health departments here and abroad.
  The first substantial effort, started before the anthrax attacks and 
completed in 2002, was the Bioterrorism Act of 2002, which dramatically 
increased funding for the Strategic National Stockpile so that a 
national pool of countermeasures, including those to protect against 
smallpox, could be maintained. It also dramatically improved our border 
protection authorities, particularly for food imports; protected our 
water supply; dramatically increased oversight of research labs that 
handled agents that could potentially be used in an attack; and 
committed substantial new resources to our state public health systems 
and hospitals to ensure improved surveillance and surge capacity. 
Institutionally, it also created a number of new Federal authorities to 
identify and develop and coordinate our response to a threat.
  In 2003 and 2004, following the President's call and leadership, we 
passed the bipartisan Project BioShield Act to confront weaknesses in 
our ability to have the research enterprise speed results to us and to 
have FDA speed products to potential victims. Notably, we pre-funded a 
$5.6 billion account to assure the developers of countermeasures that 
if they delivered a product that protected this country from a 
biological attack then the Government would in fact have the resources 
to purchase that product and recognize their work.
  Project BioShield recognized that we had very little on hand to 
address even the handful of agents that pose the greatest threat, such 
as smallpox, anthrax, botulism and plague. As a result, we have made 
valuable progress.
  Our smallpox stockpile has grown from 90,000 doses of smallpox 
vaccine ready for use in 2001 to 300 million doses today. We have 
modified vaccinia Ankara, a next-generation smallpox vaccine that 
promises greater safety, in clinical testing and others in 
predevelopment. In addition, we have a new oral form of an antiviral 
drug cidofovir in advanced product development for use in the event of 
a smallpox attack and to treat the rare complications from the smallpox 
vaccine.
  To combat anthrax, a new recombinant vaccine is in clinical testing 
and may need fewer doses than the classic vaccine, and the Department 
of Health and Human Services has contracted with VaxGen to purchase 75 
million vaccine doses under BioShield. New anthrax therapies that can 
neutralize the anthrax toxin are also being developed, such as 
monoclonal and polyclonal antibodies.
  To combat botulism, treatments for the toxin and a vaccine to prevent 
the disease are in development. And finally for Ebola a new vaccine is 
in development.
  Project BioShield was a good start, but we must do more. As the 
authors of the Center for Biosecurity report note: The legislation 
represents a significant step for the government and demonstrates [its] 
seriousness [but] is only a necessary first step.
  We have identified dozens of agents that could be used against our 
people, yet we still lack vaccines and treatments for some of the 
gravest biological and chemical threats, such as ricin, plague, and 
viral hemorrhagic fever. We still lack an antidote to sulfur mustard 
and nitrogen mustard--and those available for sarin and VX have 
significant limitations in their practical utility given the speed with 
which they need to be applied.
  We are also not prepared to fight naturally occurring infectious 
diseases--such as avian flu--that could be equally as deadly and could 
be weaponized in the future. And experts in HELP testimony, as well as 
those responding to a

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comprehensive survey by the University of Pittsburgh Center for 
Biosecurity, note the increasing threat of new bio-engineered and 
genetically modified pathogens. A 2003 CIA review confirms that these 
strains could be ``worse than any disease known to man.'' Many have 
observed that we in fact need to move beyond the product-by-product and 
bug-by-bug approach of BioShield and address solutions more 
comprehensively and innovatively.
  And we have seen a very anemic response within the research and 
manufacturing sectors to engage in biodefense work. Fewer than 100 
companies have come forward with even a modest interest in developing 
countermeasures for bioterrorism and other agents. The profile of these 
companies is in many ways positive--they are entrepreneurial, often 
have crucial insights into a bioterrorism agent or product, can move 
quickly, and many have strong venture capital connections. However, in 
other critical ways they lack the ability in our current environment to 
deliver a finished, effective product to potential victims. These same 
companies tend to be small, often work on only a single product, rarely 
have the capital required to bring a product to market, and typically 
have limited ability to manufacture a product at the level and with the 
speed required to respond fully to an emergency. BioShield has done 
little to address these latter concerns.
  The President's Commission stated that to combat this continuing 
threat, the Intelligence community, and the government as a whole, 
needs to approach the problem with a new urgency and new strategies. We 
are in fact pushing our luck.
  This is precisely why BioShield II--a bill that I introduced as part 
of S. 3--is critical to our efforts in the war against terrorism. S. 3 
clearly indicates that the Senate Republican leadership puts a very 
high priority on invigorating our biodefense capability. The people and 
10 organizations that will be on the front lines of national defense 
will no longer be just traditional defense industries--providing arms 
and artillery--but will now include biomedical research and 
biotechnology manufacturing sectors, as well as health care delivery 
systems.
  Building this biodefense sector is the first step in winning what 
could be the arms race of the 21st century. We must be secure in the 
ability of this sector to prevent and defend the United States against 
biological weapons. If we are capable of developing a vaccine or some 
other treatment that will neutralize the effect of these types of 
biological agents, including genetically modified pathogens, then they 
are less likely to be used against us. This same sector must also be 
positioned to fight new natural threats, such as a pandemic of avian 
flu. And, as highlighted by a recent GAO report on Anthrax Detection, 
we need improved detection and testing methods to accurately determine 
when an agent has been released and when an area has been 
decontaminated and is safe. Similarly, as the Washington Post helped 
uncover, BioWatch style technologies need to be dramatically improved, 
so that we have confidence in the detection of airborne pathogens 
affecting our key cities. Currently, lab analysis, even when it is 
correct, requires days to return results on only 10 agents to date.
  A range of experts, including researchers, government officials, and 
manufacturers, told us in hearings that they need greater Federal 
assistance for them to bear the risk of developing products to counter 
biological threats or infectious disease that also divert capital away 
from the development of other important and often more profitable 
drugs. Many of the measures in BioShield II legislation, including 
financial incentives, intellectual property protection, and liability 
protection were recommended during those hearings.
  A key point here is that we need to ensure the participation in this 
enterprise of not just small, fleet, and innovative biotechnology 
companies. We need to broaden our attention to large, experienced 
companies, with multiple sources of financing, the ability to 
manufacture, license, and bring to market a product, and do so on a 
large scale in an emergency. Additional measures are needed to 
encourage potential research, manufacturing, and health care delivery 
partners to commit substantial resources and take the risks necessary 
to bring innovative new products to market.
  The number-one threat cited by experts in our hearings and experts in 
a range of forums and publications is the almost boundless liability 
exposure associated with developing these products--and the resulting 
massive cost of product liability law suits. The unfortunate liability 
experience of Bayer, manufacturer of Cipro, bears witness to the 
exposure a biodefense manufacturer faces--and the litigation costs that 
will be incurred even when, as in the Bayer case, the manufacturer is 
eventually absolved.
  Manufacturers of biodefense countermeasures typically risk exposure 
to devastating product liability lawsuits to a far greater degree than 
typical drug companies and for this reason are unlikely to get 
commercial liability insurance for countermeasure products. There are a 
number of reasons. For example, as Project BioShield specifically 
contemplates, such countermeasures may be made available without the 
usual battery of clinical trials required for other FDA-approved 
products. Safety and efficacy data often must be derived, for the most 
part, from animal trials because healthy humans cannot be exposed to 
toxic agents during testing for obvious reasons.
  Further, the scope of distribution of biodefense products and their 
method of distribution heightens the risk of a lawsuit--even if the 
product is otherwise safe and effective. For example, when distributed 
to large numbers of potential victims, perhaps millions of Americans in 
an emergency, there will inevitably be harm or injuries that occur 
around the time of the use of the product but that are in fact 
associated with the inevitable pre-existing health conditions in that 
large population. Determining the cause of the harm and distinguishing 
between the product and other factors will be nearly impossible--and 
yet liability exposure is evident. Methods of distribution in an 
emergency, perhaps using less trained persons as a last resort, also 
increase risk of liability.
  Large, responsible, successful companies are--without liability 
protection-- the most likely to remain on the sidelines for fear of 
risking corporate assets in defending lawsuits. And with other sources 
of revenue, other successful products, and products generally with 
higher profit margins, these same companies in fact act prudently in 
protecting their general corporate assets from unnecessary litigation 
associated with lower-margin biodefense products.
  Even as Government has begun to purchase BioShield countermeasures, 
the Government's ability to limit liability has significant 
limitations. Under current law there are only two legal authorities 
that allow the Federal Government to mitigate the liability concerns of 
producers of countermeasures other than small pox vaccine.
  The first is through Federal indemnification under Public Law 85-804. 
The second is through designation/certification under the SAFETY Act. 
Both of these measures are woefully inadequate to address the practical 
realities of potential litigation facing providers of countermeasures 
and the fiscal realities facing the Federal Government.
  Protection under Public Law 85-804 and its executive order extension 
to biodefense products is not frequently granted. When it is, the 
primary limitation is that the administration typically will not 
address indemnification prior to award of a contract for a 
countermeasure--unlike the Department of Defense, which typically does 
address liability earlier in the process. As a result, potential 
providers must expend resources to compete for a contract that they may 
have to refuse due to the lack of liability protection. More often 
companies simply refuse to bid at all due to lack of certainty on the 
issue of liability. Numerous technical and definitional limitations on 
the scope of the indemnification also exist--Is the product inherently 
dangerous? Is it involved in national defense?--not to

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mention the nature of indemnification may expose the Federal Government 
to enormous liability exposure as awards and liability is not 
structured or limited in any way.
  The practical utility of SAFETY Act protections to biodefense 
products is limited. For example, the potential liability of a provider 
of a vaccine that is administered prior to a bioterror attack is not 
addressed--leaving producers of vaccines in particular, as they are 
typically dispensed prior to an attack, at great risk of liability 
exposure. Protection also requires a burdensome pre-certification 
process that has not resulted yet in designation of any biotechnology 
products. Clearly dramatic improvements on this model are required.
  The net impact of this atmosphere results in needed countermeasures 
not being developed and deployed, thereby exposing the economy, and the 
Nation as a whole, to far greater potential liability due to the lack 
of available effective countermeasures in the event of attack. Either 
way, the Federal Government is likely to bear both the human and 
financial cost of such an attack as it did on September 11th. But by 
failing to account for these costs before an attack, countermeasures 
will not be developed and the Nation will be more exposed to attack, 
costing America both lives and economic stability.
  S. 3, which contains liability protections based on the SAFETY Act, 
attempts to address these liability concerns not only for terrorism, 
but also countermeasures developed and deployed to protect the Nation 
against naturally occurring epidemics such as SARS and pandemics such 
as Avian influenza. Further, liability protections would be extended to 
ensure that those delivering health care in an emergency, including 
biodefense products, receive due protection for 19 stepping up and 
protecting our country when it is under attack. Further, S. 3 puts some 
limits on the almost boundless liability exposure.
  The second most significant barrier to investment in biodefense 
technology, according to experts testifying before the HELP committee 
and other public documents is the failure of current intellectual 
property law to adequately recognize and protect a researcher or 
manufacturer's investment in a technology.
  The current law mechanism for this involves a combination of patent 
term extensions and grants of market exclusivity for a product, which 
permit a patent term essentially to be extended to compensate for 
periods of time while a countermeasure is in the regulatory review or 
other process.
  Under current law, there are several arbitrary limits placed on the 
duration and nature of the patent extensions that may be granted on a 
pharmaceutical product. First, the total effective period of the patent 
from the date the drug is approved until the patent expires cannot 
exceed 14 years. Second, no patent extension can exceed 5 years. In 
addition, only partial credit for a patent extension is granted for the 
lengthy time the product undergoes research and development before an 
application is reviewed by the FDA. S. 3 would create a patent term 
extension authority that is not subject to these arbitrary limits. This 
type of incentive is also important to recoup some of the innovator or 
manufacturer's investment in developing the product and for diverting 
resources from manufacturing other more profitable drugs.
  As an alternative, S. 3 provides a second type of patent provision to 
permit the Government to reward manufacturers who work to develop a new 
countermeasure use from an existing product or technology during an 
emergency. This provision could, for example, have been useful with the 
drug Cipro, used as a therapeutic for a number of reasons, but at that 
time not otherwise studied for use as a treatment for anthrax exposure. 
During the anthrax attacks, the government asked the company to step 
forward--the company responded by researching and developing 
considerable evidence that their product was indeed safe and effective 
for treatment following anthrax exposure. Under current law, Americans 
can only rely on the unselfish generosity of a company to expend these 
resources to provide the safety and effectiveness data we need. Under 
my legislation, depending on circumstances, additional incentives 
involving market exclusivity could be granted for up to two years for 
the product that was used as a countermeasure. This is an important 
distinction from the so-called ``wild card'' exclusivity idea, which 
would allow a company to extend the patent protection of a different 
product as a reward for stepping forward. Again, this type of incentive 
will encourage manufacturers to step forward in a crisis and will help 
them recoup their losses from diverting their research and 
manufacturing efforts from more profitable products.
  We've heard resoundingly that our research, manufacturing, and health 
care delivery sectors need reasonable assurances that a market for 
these products will in fact exist should they invest the resources 
necessary to fully develop them. Under the BioShield approach the 
manufacturer takes the gamble for product development--the government 
as the sole purchaser needs to be a reliable partner. I look forward to 
continuing to discuss viable approaches in this area. In my view, 
however, it is not politically viable to have that basket of options or 
incentives include ``wild-card'' exclusivity--or the ability to apply a 
patent extension or market exclusivity to any product in a company's 
portfolio, regardless of whether it has any use for biodefense 
purposes. Today, politically, the reality is that this approach is not 
sustainable--even if it would serve as a powerful incentive to 
companies to step up and deliver much-needed biodefense products.
  The role of the government in facilitating research, development, and 
delivery of biodefense products can be great. Unfortunately, all too 
often, government gets in the way. Accordingly, S. 3 also contains 
important regulatory reform initiatives for protecting Americans 
against bioterrorism. First, it has provisions that will improve the 
international harmonization of U.S. Food and Drug Administration 
regulations with those of the regulatory bodies of our allies in 
Europe, Canada, and other developed countries. This will help 
facilitate the development and approval of biodefense products, and 
will reduce the costs of regulation by the United States and these 
countries of biodefense countermeasures such as drugs, vaccines and 
medical devices. Streamlining and making truly effective the regulatory 
approaches from these developed countries will also assure the 
continued safety and effectiveness of these medical countermeasures. S. 
3 also requires additional reviews by experts on how to improve 
regulation of these products.
  Second, the bill includes important provisions to assure uniformity 
throughout the United States of biodefense product labeling and other 
FDA-regulatory requirements. We urgently need this provision to respond 
in a uniform and united way to a potential bioterrorist attack or other 
deadly epidemic.
  Dramatically conflicting or confusing state and local labeling and 
composition requirements will limit the ability of Americans across the 
country to respond adequately and quickly. It is important to note that 
the provision includes language for exempting purely local matters such 
as pharmacy practice laws from national uniformity requirements and 
unique local conditions.
  The Bioterror Act of 2002 took significant steps forward to address 
public health infrastructure needs of the country. BioShield II builds 
on these authorities in an effort to prioritize resources to those 
areas faced with the greatest threat--to build the technical expertise 
of the federal workforce, particularly at our premier biomedical and 
health organizations at NIH, FDA, and CDC--and to build private sector 
response capacity in various private-public arrangements designed to 
have credentialed, expert, and trained teams on hand to respond quickly 
to a crisis. Surveillance authorities here and abroad also need to be 
strengthened and developed--using innovative private sector analysis of 
prescription

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drug, hospital emergency room and doctor visits and other ``leading 
indicators.'' In short, as Richard Falkenrath of the Brookings 
Institution notes, ``there's no area of homeland security in which the 
administration has made more progress than bioterrorism, and none where 
we have further to go. But, it is critical to agree with Elin Gursky 
with the Anser Institute for Homeland Security, ``This problem won't be 
solved by money alone.''
  We have an obligation to be prepared for the worst threat. Maybe that 
``next'' attack will never come. Or maybe it will come tomorrow.
  We can't know where or when it will come or what our enemies will try 
to do. We have to be prepared for all possibilities. Therefore, we have 
to have a vibrant and strong biotechnical industry, a biomedical 
industry, and an atmosphere here in the Federal Government which 
encourages the development of the vaccines and other antibodies which 
will allow us to address these type of threats.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Ms. STABENOW. Mr. President, I ask unanimous consent that the order 
for the quorum call be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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