Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of S. 15, the Project Bioshield Act of 2004. The bill provides the government with the necessary tools to develop and purchase vaccines and other drugs…
Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of S. 15, the Project Bioshield Act of 2004. The bill provides the government with the necessary tools to develop and purchase vaccines and other drugs to protect Americans in the event of a bioterrorist attack. The President first announced this proposal during his 2003 State of the Union address, and it serves as the cornerstone of the administration's strategy to prepare our Nation against the possibility of bioterrorism.
A few minutes ago, we were privileged to hear from the chairman of the Select Committee on Homeland Security, the gentleman from California (Mr. Cox); and I will include for the Record an editorial written by the gentleman from California that appeared in the Washington Times and published July 12, 2004.
[From the Washington Times, July 12, 2004]
Intercepting Bioterrorism
(By Christopher Cox)
America is at a very dangerous crossroads. Not only al
Qaeda but also terrorist groups such as Jemaah Islamiah are
working on acquiring or developing new terrorism
capabilities, including bioweapons. Will we be prepared?
Evidence in an Egyptian terrorism trial two years ago
indicated Osama bin Laden may already have access to
dangerous biological agents. Meanwhile, the risk of
proliferation to terrorists continues growing, with at least
eight nations running bioweapons programs, including genetic
engineering of pathogens and developmental programs for new
production and delivery methods.
Winning the war on terrorism will require our nation not
only to defeat attacks with explosives and military-style
weapons, but also to be prepared to overcome potential
assaults with weaponized anthrax, ricin, smallpox, plague,
tularemia, botulism toxin and viral hemmorhagic fevers (such
as the Ebola virus).
Just how vulnerable are we to such attacks today? The
United States now can fully meet only a handful of the 57
``top echelon'' bioterror threats. That's not an acceptable
level of preparedness for the greatest power on Earth. We can
launch a Tomahawk cruise missile and thread it down the
smokestack of a munitions factory from 1,000 miles away--once
thought to be a million-to-one shot at best--yet we aren't
prepared to deal with the frightening prospect of an anthrax
or sarin gas attack against our civilian population.
It's vital that we put our best minds to work round-the-
clock on new ways to prepare for a biological or chemical
attack here at home. But according to a study published in
the May 2004 issue of the journal Clinical Infectious
Diseases, only six of 506 drugs currently in development are
antibioltics--even though drug-resistant bacteria are a
growing threat.
This is only because the proper incentives and funding
aren't there, not because the scientific challenge is too
great. Indeed, the germs that cause anthrax and plague are
not nearly as difficult to analyze as a virus such as HIV.
Vaccines and treatments for biological weapons such as these
can be developed.
Certainly, America has made some progress in preparing for
possible germ warfare on our own soil, but we're not ready to
combat a major bioterror assault at this time and our enemies
know it. Worse, they're looking for ways to exploit our
weaknesses.
We are now on the threshold of changing that. Project
Bioshield, expected to receive final legislative approval
tomorrow and then be sent to the president for his signature,
will shortly unleash the greatest force in world history:
American ingenuity.
By guaranteeing a market for successful vaccines and
antidotes, Project BioShield will provide incentives for
private-sector scientists, physicians, and researchers to
develop lifesaving treatments. Congress has made available
$5.6 billion over 10 years to purchase and stockpile a
national supply of drugs and vaccines for use if a biological
weapon is set loose by terrorists on an unsuspecting American
public.
BioShield will speed research and development on new drugs
and antidotes at the National Institutes of Health and in our
national laboratories. And it will allow, if germ warfare
breaks out, distribution of developmental lifesaving drugs on
a fast-track approval basis to save innocent lives, so long
as the benefits outweigh potential risks.
President Bush asked Congress to move immediately on his
plans for Project BioShields in the 2003 State of the Union
address. The House quickly responded. Last July, the
Homeland Security Committee, which I chair, worked closely
with other House committees to turn the president's vision
into legislation. Unfortunately, after our bipartisan bill
passed the House by a wide margin, it languished in the
Senate nearly a year before being rescued by Majority
Leader Bill Frist, Tennessee Republican.
But now that both chambers have worked out their
differences, America finally is ready to prepare in earnest
for a potential terrorist attack that won't yield to bullets
or bombs. Now, we'll be using the very best weapon in our
defensive arsenal--our brainpower.
By approving Project BioShield, Congress is saying: ``Let
the race to find lifesaving countermeasures begin.''
America's leaders have heeded the advice of experts who have
estimated that without BioShield it could take 10 years, and
cost up to $800 million or more, to bring a single new
vaccine from development through clinical trials to market.
The war won't wait that long, of course: Terrorists could
strike us at any minute. And once a bioweapon is released,
every second will count.
In many ways, the war on terrorism is like a chess game. We
must anticipate our enemy's moves, and mount an impenetrable
defense. In their pursuit of bioweapons, the terrorists have
revealed some of their game plan. Project BioShield will
ensure we stay one move ahead of them.
Someday soon, when it comes to bioterrorism, Americans will
be able to say: Checkmate.
Mr. Speaker, the bipartisan bill we are considering today is similar to H.R. 2122, which was passed by the House on July 16, 2003. S. 15 is a good bill that serves a compelling national interest.
Over the past few decades, we have seen rapid progress in the development of treatments for many serious, naturally occurring diseases. Pharmaceutical and biotech companies are highly capable of producing diagnostics and therapeutics when consumer demand exists. However, there has been little progress in treatments for deadly diseases like smallpox, anthrax, ebola, and plague that affect today few Americans. There is little manufacturer interest in developing treatments for these diseases since there is no significant market, other than the government.
Drug companies have little incentive for the substantial investment required to bring treatments to these deadly diseases to market. Moreover, the potential liability for an adverse reaction by a patient far outweighs any potential financial benefit in some of these cases.
Should the United States be attacked with these deadly pathogens, however, the need for vaccines, tests and treatments would be great and immediate. S. 15 is designed to ensure that our country is prepared.
The bill provides the Secretary of Health and Human Services with a number of flexible acquisition tools based on existing streamlined procedures to promote research and development and procure necessary drugs and vaccines. These tools are instrumental to the success of the Bioshield program.
S. 15 gives the Secretary of Health and Human Services streamlined authorities to promote the research and development of drugs and other products needed to protect Americans in the event of a public health emergency affecting national security. The Secretary will be armed with flexible acquisition tools for research and development projects and would also have expedited authorities to award research grants and to hire technical experts and consultants. It would not be burdened with the existing procurement processes that could take months.
The bill authorizes the procurement of biomedical countermeasures for the Nation's stockpile, using a special reserve fund. The Secretary of Health and Human Services and the Secretary of the Department of Homeland Security would be required to work together to recommend the countermeasures that are needed for the stockpile. Acquisition of countermeasures
using the special reserve fund could only be made with the approval of the President of the United States.
This bill would permit the use of simplified acquisition procedures only when the Secretary of Health and Human Services determines that the mission of the Bioshield program would be seriously impaired without the use of such special procedures.
Finally, during national emergencies, the bill would permit the government to make available new and promising treatments prior to approval by the Food and Drug Administration.
I especially want to thank my ranking member, the gentleman from California (Mr. Waxman), and his staff for working with us on this important legislation. I urge my colleagues to support it.
Mr. Speaker, I reserve the balance of my time.
Mr. Speaker, I thank the gentleman from Texas and others who have been involved in getting this legislation before us.
Let me just say I share the frustration that many Members of this body feel at the time it has taken to get this measure to this floor, in a conference report form, and then send it on to the President's desk for signature. We passed this legislation with bipartisan support a year ago, and it languished over in the other body until it was rescued by Senator Frist.
The time is late, but the time is now. I urge my colleagues to adopt and support this legislation.
Announcement by the Speaker Pro Tempore
Speaker, I yield back the balance of my time.
Mr. Speaker, on that I demand the yeas and nays.