Project Bioshield Act

Project BioShield Act of 2004
Long title	An Act To amend the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health contracting flexibility, infrastructure improvements, and expediting the scientific peer review process, and streamlining the Food and Drug Administration approval process of countermeasures
Enacted by	the 108th United States Congress
Citations
Public law	108-276
Statutes at Large	118 Stat. 835–864
Codification
Titles amended	42: Public Health and Social Welfare
U.S.C. sections amended	Chapter 6A § 201
Legislative history
	Introduced in the Senate as S. 15 by Judd Gregg (R-NH) on March 11, 2003; Committee consideration by Senate HELP ; Passed the Senate on May 19, 2004 (99-0); Passed the House on July 14, 2004 (414–2); Signed into law by President George W. Bush on July 21, 2004;

Last updated March 13, 2024

The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack.^[1] This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.^[2]

Since the 2001 terrorist attacks, the United States government has allocated nearly $50 billion to address the threat of biological weapons. U.S. funding for bioweapons-related activities focuses primarily on research for and acquisition of medicines for defense. Funding also goes toward stockpiling protective equipment, increased surveillance and detection of biological agents, and improving state and hospital preparedness. The increase in this type of funding is mainly for Project BioShield. Significant funding also goes to Biomedical Advanced Research and Development Authority (BARDA), part of HHS. Funding for activities aimed at prevention has more than doubled 2007 and is distributed to 11 federal agencies.^[3] Efforts toward cooperative international action are part of the project.

Provisions

Amends the Public Health Service Act to authorize the Secretary of Health and Human Services (HHS) to: (1) conduct and support research and development activities for countermeasures in biological emergencies and provide that biocontaminant laboratories and specialized research facilities will be available to the Secretary to respond to public health emergencies affecting national security.
Allows the Secretary to expedite purchasing related to research and development needs by simplifying limits on procurement.
Allows the Secretary to respond to pressing research and development needs, including expediting peer review, contracting with experts, and appointing employees to positions at the National Institutes of Health.
Amends the Public Health Service Act to allow the Director of the NIH to act through the Director of the National Institute of Allergy and Infectious Diseases (NIAID) to provide grants for the modernization and construction of research facilities. Increases the Federal share of such NIAID-funded projects.
Provides funding for the National Vaccine Program for FY 2004 and 2005.
Adds the Secretary of Homeland Security (DHS) to the working group on the prevention, preparedness, and response to bioterrorism and other public health emergencies.
Amends the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to direct the Secretary to coordinate with Homeland Security to maintain the Strategic National Stockpile and deploy the Stockpile to respond to an emergency.
Allows security countermeasures to be procured using the special reserve fund (an appropriations account set up by to this Act). A "security countermeasure" is a countermeasure that is either authorized for emergency use or that the Secretary determines is a priority, is necessary, and is an approved drug or a drug reasonably likely to be approved within eight years.
Provides that in order for a countermeasure to be procured using the special reserve fund: (1) HHS must identify a chemical, biological, radiological or nuclear agent as a threat to the U.S. population that may affect national security; (2) HHS must determine that a countermeasure is necessary to protect public health; (3) HHS must assess the availability and appropriateness of the countermeasure to address the threat; (4) DHS and HHS must jointly submit a proposal to the president to issue a call for the development of countermeasures that are not available or cleared only for alternative purposes; (5) DHS and HHS must make a commitment to recommend that the special reserve fund be available for the procurement of a countermeasure; (6) the President must approve the proposal; (7) DHS and HHS must make specified information known to those who may respond to a call for the countermeasure including the specifications of the needed countermeasure; (8) HHS must determine which countermeasures can be procured using the special reserve fund; (9) the HHS and DHS and the Director of the Office of Management Budget must submit a recommendation to the President that the special reserve fund be used to procure the countermeasure; and (10) the President must approve the recommendation. HHS and DHS must notify designated congressional committees promptly that a material threat has been identified and countermeasures are necessary to protect the public health and that the President has approved a recommendation for countermeasure procurement using the special reserve fund. Authorizes appropriations for the special reserve fund to procure security countermeasures approved by the President, for the hiring of personnel to carry out terror threat assessments, and for the development of secure intelligence-sharing facilities. Transfers the functions, personnel, assets, unexpended balances, and liabilities of the Stockpile from the Secretary of Homeland Security to the Secretary of Health and Human Services.
Amends the Homeland Security Act to change the responsibilities of the Secretary of Homeland Security as they relate to the Stockpile.
Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to authorize the use of a drug, device, or biological product intended for emergency use, specifically allowing the use of unapproved products, or the unapproved use of approved products, upon a determination by DHS that there is or is a significant potential for a domestic emergency, or upon a determination by DHS of a public health emergency that affects or may affect national security and that involves a specified agent or a specified disease that may be attributable to such agent. Amends the National Defense Authorization Act to continue provisions governing the emergency use of products with respect to members of the Armed Forces. The Secretary can authorize the use of unapproved products in an emergency only upon a determination by the Secretary of Defense of a military emergency involving a heightened risk to U.S. forces of an attack.
Requires the Comptroller General to: (1) review the Secretary's use of the authorities granted under this Act; (2) assess the adequacy of the internal controls instituted by the Secretary; (3) identify any procurements that would have been significantly delayed or not made without the authorities provided to the Secretary; (4) determine to what extent authorized activities under this Act have enhanced the development of biomedical countermeasures; (5) assess the availability of countermeasures to address threats; (6) assess the extent to which programs and activities will reduce a gap between the threat and the availability of countermeasures to an acceptable level of risk; and (7) assess the threats to national security posed by technology that will enable the development of antibiotic-resistant, mutated, or bioengineered strains of biological agents and recommend strategies for addressing such threats, and make recommendations on possible improvements.
Directs the Secretary, the Secretary of Homeland Security, and the Secretary of Defense to ensure that the activities of their respective Departments coordinate, complement, and do not unnecessarily duplicate programs designed to protect the homeland from biological, chemical, radiological, and nuclear agents. Directs such Secretaries to each appoint an official to coordinate such programs for their respective Departments.

Act accomplishments

Progress has been made in the establishment of both national requirements and acquisition strategies, as well as the procurement of pre- and postexposure countermeasures to meet the threat from anthrax, botulinum toxins, smallpox, and radiological and nuclear threats.

United States Department of Health and Human Services (HHS) has taken a number of additional steps to accomplish the goal of effectively and efficiently implementing the Project BioShield Act. HHS has reorganized the Assistant Secretary for Preparedness and Response (ASPR) (formerly the Office of Public Health Emergency Preparedness) and established a dedicated strategic planning function that more efficiently integrates biodefense requirements and streamlines the interagency governance process. Under the reorganized structure, on behalf of the secretary of HHS, the ASPR leads the federal public health and medical response to acts of terrorism or nature and other public health and medical emergencies. In 2006, HHS announced, in the Federal Register Notice of 6 July 2006, the establishment of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).^[4]

Acquired vaccines

In September 2012 BioPrepWatch reported that the BARDA annual report shows that the number of supplies of countermeasures for combating terrorist attacks is growing.^[5]

According to the report, BARDA has acquired:^[5]

107,000 doses of an antitoxin for Clostridium botulinum (a decrease from the full 200,000 doses ordered in 2006).
57,102 doses of the monoclonal antibody Raxibacumab, which treats anthrax, from Human Genome Sciences in 2011. This included 20,000 doses under a 2005 contact and 37,102 doses of the 45,000 ordered in a 2009 contract option. At the end of 2010, there was a total supply of 36,102 doses of Raxibacumab.
10,000 doses of anthrax immune globulin from Cangene, which also treats anthrax. By 2010, the supply was down to 7,327 doses, with spending on Raxibacumab and AIG coming to $478 million.
28.75 million doses of the anthrax vaccine BioThrax from Emergent BioSolutions.
Botulism treatments, as well, including 107,560 doses of Botulinum Antitoxin Therapeutic from Cangene. It ordered 200,000 doses. At the end of 2010, the supply was at 97,000 doses.

Related legislation

Section 401 of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress) reauthorized the BioShield Project.^[6] More specifically, it reauthorizes the Project BioShield Special Reserve Fund (SRF), originally established in 2004.^[7]

Recent news

To June 2013, eight medical countermeasures (MCM) against anthrax, smallpox, botulinum toxin and radiological threats have been procured. Eighty other candidate MCMs are undergoing advanced development. The authorities and funds contained in the Project BioShield Act were slated to expire at the end of year 2013. The legislative experiment of BioShield was subject to evaluation and reconsideration in the House and the Senate, which both passed versions of reauthorization legislation.^[8]

In March 2013 funding was extended through 2018 via the Pandemic Act. "Pandemic and All-Hazards Preparedness Reauthorization Act". US Department of Health and Human Services. March 2013. Retrieved 23 Feb 2017.

In February 2018 the Bipartisan Policy Center released a report called "Budgeting for Medical Countermeasures: An Ongoing Need for Preparedness." Based on the report, former U.S. Senator Tom Daschle (D-SD) said that the change in the way that the Project BioShield Act of 2004 is funded (it changed from a ten-year appropriations cycle to year-by-year funding) creates a climate of uncertainty for private firms looking to invest in medical countermeasures (MCM) against chemical, biological, radiological or nuclear (CBRN) agents. No commercial market exists for MCMs, so the firms that research and develop MCMs have to depend on a reliable stream of government money. According to Homeland Preparedness News, "Daschle and [former U.S. Sen. Judd] Gregg offered budgeting strategies that they believe could lend stability to the MCM arena, some of which would call for changes to statutory processes and congressional procedures that have been implemented since the Project BioShield Act's 2004 enactment."^[9]

Published literature

A 2005 review reported that the project had an advanced appropriation for countermeasures—ranging from vaccines to biodosimetry to surveillance—related to biological weapons and other WMD.^[10] Provisions have been made as well to ensure safer and more effective vaccinations for such threats such as smallpox. Another issue lies within the US Food and Drug Administration (FDA). The FDA requires clinical studies of human safety and efficacy. The Journal of the American Osteopathic Association notes that this kind of testing for biological weapons is ethically unacceptable to conduct on humans. "The need for expedited development of critical countermeasures must be balanced against the need to ensure that these essential interventions are safe as well as effective."^[10]

A 2007 review stated that the project is needed because when the only market is the government, there is a high risk of failure and a low expectation of profit. This discourages other manufacturers from investing research, development and funds in the bioterrorism products to be sold, because the expected profits do not justify the opportunity costs. Pharmaceutical and vaccine manufacturers can perceive the federal government as an uncertain and low-profit market. The project was developed in an attempt to provide a financial incentive to manufacturers to develop the products needed for defense against CBRN threats.^[11]

A perspective piece published in The New England Journal of Medicine in 2009 noted that the FDA issued Emergency Use Authorization (EUA) to use an unapproved drug in case of an emergency, but also noted that this could only issued only after the secretary of health and human services has declared a public health emergency. "In the case of the 2009 H1N1 influenza pandemic, such a declaration was made on April 26, 2009. An EUA for a medical product has a term of one year, but it can be renewed, depending on the circumstances of the emergency. It is important that product development continue to focus on the goal of approval (there are ongoing clinical trials evaluating the efficacy of intravenous peramivir in treating influenza), because the EUA is only a temporary means for making a product available during an emergency."^[12]

A book published in 2010 stated that the project allows the Secretary of Health and Human Services to purchase unapproved and unlicensed vaccinations. The HHS will determine that "...sufficient and satisfactory clinical experience or research data...support(s) a reasonable conclusion that the product will qualify for approval or licensing...within eight years."^[13] The HHS will write contracts on these unapproved products, help lowering the purchasing cost of the drugs.

Challenges and criticism

Some provisions of Project BioShield are controversial. Some critics suggest that biotechnology and pharmaceutical companies will require even more incentives than contained in these proposals from the Government.

The project's funding would be subject to annual review through the appropriations process. Furthermore, the law would require the HHS Secretary to prepare annual reports detailing actions taken under this Act including identification of each person or entity that received, or was considered and rejected for grants, cooperative agreements, or contracts under this Act. The approval and licensing processes are designed to preclude the marketing of ineffective and dangerous treatments. Only about 20% of drugs that begin the approval process actually become approved treatments. Because it is not possible to predict the outcome of the approval process, critics of this provision suggest that the government will end up purchasing countermeasures that will eventually fail to be approved.^[14]

Obstacles to pharmaceutical and vaccine development include inadequate funding for research, insufficient protections against corporate liability, and constraints related to safety considerations. Typically, the drug-development process in the United States is largely initiated by the National Institutes of Health, which supports basic research through funding scientists. Although the development of a new medication usually takes several years between the time that research begins to the time that the medication is marketed, developing medical interventions against potential biological weapons is especially intense in terms of time, labor, and finances.^[10] There is also no guarantee that the drug companies will purchase the vaccinations.

PhRMA

In 2005 the chief medical officer for biomedical preparedness at the Pharmaceutical Research and Manufacturers of America in Washington DC voiced additional financial concerns of the pharmaceutical industry. Michael Friedman MD explains that manufacturers of biological defense products could still be "exposed to devastating product-liability suits," adding, "The decision to divert resources from the research and development of medicines for serious illnesses like heart disease can be financially risky, especially when a countermeasure may never be purchased or used." Friedman argues there needs to be more sponsored research and collaborative programs that engage government, academia, and industry, as well as additional incentives for private companies.^[10]

Related Research Articles

Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents include bacteria, viruses, insects, fungi, and/or their toxins, and may be in a naturally occurring or a human-modified form, in much the same way as in biological warfare. Further, modern agribusiness is vulnerable to anti-agricultural attacks by terrorists, and such attacks can seriously damage economy as well as consumer confidence. The latter destructive activity is called agrobioterrorism and is a subtype of agro-terrorism.

Biodefense refers to measures to restore biosecurity to a group of organisms who are, or may be, subject to biological threats or infectious diseases. Biodefense is frequently discussed in the context of biowar or bioterrorism, and is generally considered a military or emergency response term.

The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of the U.S. people and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW).

The Strategic National Stockpile (SNS), originally called the National Pharmaceutical Stockpile (NPS), is the United States' national repository of antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. Its website states:

"The Strategic National Stockpile's role is to supplement state and local supplies during public health emergencies. Many states have products stockpiled, as well. The supplies, medicines, and devices for life-saving care contained in the stockpile can be used as a short-term stopgap buffer when the immediate supply of adequate amounts of these materials may not be immediately available."

Stewart Simonson is the Assistant Director-General of the World Health Organization responsible for the WHO Office at the United Nations and the WHO-US Liaison Office. He also serves as the Director-General's Special Representative for UN Reform. Prior to his assignment in New York, Simonson was the Assistant Director-General for the General Management Group at WHO headquarters in Geneva, Switzerland.

The Biodefense and Pandemic Vaccine and Drug Development Act of 2005, nicknamed "Bioshield Two" and sponsored by Senator Richard Burr, aims to shorten the pharmaceutical development process for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries. The proposed bill would create a new federal agency, the Biomedical Advanced Research and Development Agency (BARDA), that would act "as the single point of authority" to promote advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks, while shielding the agency from public Freedom of Information Act (FOIA) requests. BARDA would be exempt from long-standing open records and meetings laws that apply to most government departments.

The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005, is a controversial tort liability shield intended to protect pharmaceutical manufacturers from financial risk in the event of a declared public health emergency. The part of PREPA that actually affords such protection is now codified at 42 U.S.C. § 247d-6d. The act specifically affords to drug makers immunity from actions related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS). PREPA provides $3.8 billion for pandemic influenza preparedness to protect public health in the case of a pandemic disease outbreak.

Emergent BioSolutions Inc. is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland. It develops vaccines and antibody therapeutics for infectious diseases and opioid overdoses, and it provides medical devices for biodefense purposes.

The Biomedical Advanced Research and Development Authority (BARDA)' is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases. BARDA was established in 2006 through the Pandemic and All-Hazards Preparedness Act (PAHPA) and reports to the Office of the Assistant Secretary for Preparedness and Response (ASPR). The office manages Project BioShield, which funds the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as chemical, biological, radiological or nuclear (CBRN) attacks.

The Administration for Strategic Preparedness and Response (ASPR) is an operating agency of the U.S. Public Health Service within the Department of Health and Human Services that focuses preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters. Its functions include preparedness planning and response; building federal emergency medical operational capabilities; countermeasures research, advance development, and procurement; and grants to strengthen the capabilities of hospitals and health care systems in public health emergencies and medical disasters. The office provides federal support, including medical professionals through ASPR’s National Disaster Medical System, to augment state and local capabilities during an emergency or disaster.

On December 19, 2006, the Pandemic and All-Hazards Preparedness Act (PAHPA), Public Law No. 109-417, was signed into law by President George W. Bush. First introduced in the House by Rep. Mike Rogers (R-MI) and Rep. Anna Eshoo (D-CA), PAHPA had broad implications for the United States Department of Health and Human Services's (HHS) preparedness and response activities. Among other things, the act amended the Public Health Service Act to establish within the department a new Assistant Secretary for Preparedness and Response (ASPR); provided new authorities for a number of programs, including the advanced development and acquisitions of medical countermeasures; and called for the establishment of a quadrennial National Health Security Strategy.

An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.

Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies.

The United States Biological Defense Program—in recent years also called the National Biodefense Strategy—refers to the collective effort by all levels of government, along with private enterprise and other stakeholders, in the United States to carry out biodefense activities.

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 is a law enacted by the 113th United States Congress. The Act amends the Public Health Service Act in order to extend, fund, and improve several programs designed to prepare the United States and health professionals in the event of a pandemic, epidemic, or biological, chemical, radiological, or nuclear accident or attack. The Act clarifies the authority of different American officials, makes it easier to temporarily reassign personnel to respond to emergency situations, and alters the process for testing and producing medical countermeasures. The Act is focused on improving preparedness for any public health emergency.

The Strengthening Public Health Emergency Response Act of 2015, H.R. 3299, is a bill introduced in the U.S. House of Representatives that would streamline government decisions and provide incentives for vaccines and treatment of dangerous pathogens and diseases. The bill was introduced by Representatives Susan Brooks (R-IN) and Anna Eshoo (D-CA).

The First Responder Anthrax Preparedness Act is a law introduced in the United States Senate by U.S. Senator Kelly Ayotte. The law will set up a pilot program that provides anthrax vaccines from the U.S. Strategic National Stockpile to first responders, the Department of Homeland Security (DHS) would create a tracking system for those who receive the vaccine, and the government would prioritize vaccines close to the end of their labeled dates. The Congressional Budget Office estimated that implementing the law would cost about $4 million over the 2016-2020 period.

The Alliance for Biosecurity is a consortium of companies that develop products to respond to national security threats, including bioterrorism pathogens and emerging infectious diseases. It is headquartered in Washington DC.

Robert Peter Kadlec is an American physician and career officer in the United States Air Force who served as Assistant Secretary of Health and Human Services from August 2017 until January 2021. He is responsible for the creation of the COVID-19 vaccine development program Operation Warp Speed.

In the United States, the National Biodefense Strategy is a biosecurity strategy that the federal government was directed to adopt by the National Defense Authorization Act for Fiscal Year 2017. The act—the periodic National Defense Authorization Act, the authorization bill for national security—required the secretaries of Defense, Health and Human Services, Homeland Security, and Agriculture to coordinate to produce a comprehensive strategy for countering biological warfare threats and other biological threats. The Donald Trump administration announced the National Biodefense Strategy of 2018 the following year. Later, the Donald Trump administration announced they would siphon funds from medical programs to supplement fundings for the strategy. When questioned about this, it was reported that the Obama administration provided the plans for the strategy.

References

↑ "President Bush Signs Project Bioshield Act of 2004". White House . July 21, 2004. Retrieved 2008-08-01. Project BioShield will transform our ability to defend the nation in three essential ways. First, Project BioShield authorizes $5.6 billion over 10 years for the government to purchase and stockpile vaccines and drugs to fight anthrax, smallpox and other potential agents of bioterror. The Department of Health and Human Services has already taken steps to purchase 75 million doses of an improved anthrax vaccine for the Strategic National Stockpile. Under Project BioShield, HHS is moving forward with plans to acquire a safer, second generation smallpox vaccine, an antidote to botulinum toxin, and better treatments for exposure to chemical and radiological weapons.
↑ Gibbs, W. Wayt (October 2004), "An Uncertain Defense", Scientific American, Scientific American, Inc., vol. 291, no. 4, pp. 20–24, Bibcode:2004SciAm.291d..20G, doi:10.1038/scientificamerican1004-20, ISSN 0036-8733, OCLC 1775222
↑ "Federal Funding for Bioweapons Prevention and Defense, by Agency, 2001-2009". Archived from the original on 2012-07-29. Retrieved 2009-03-30.
↑ Russell, Philip (2007). "Project BioShield: What It Is, Why It Is Needed, and Its Accomplishments So Far". Clinical Infectious Diseases. Oxford Journals. 45 (Supplement 1): 68–72. doi: 10.1086/518151 . PMID 17582574.
1 2 Kellen Alexander "U.S. grows its biodefense stockpile" Archived 2013-01-18 at archive.today , BioPrepWatch, 18 Sep 2012
↑ "H.R. 307". United States Congress. Retrieved 10 April 2013.
↑ "H.R. 307 - Legislative Digest". House Republicans. Archived from the original on 16 March 2013. Retrieved 10 April 2013.
↑ Kadlec, Robert (January 2013). "Renewing the Project BioShield Act - What Has It Bought and Wrought?" (PDF). Center for a New American Security . Retrieved 12 June 2013.
↑ "Former Sen. Daschle praises Trump's support of Project BioShield - Homeland Preparedness News". Homeland Preparedness News. 2018-02-14. Retrieved 2018-02-16.
1 2 3 4 Dudley, Gail; McFee, Robin (2005). "Preparedness for Biological Terrorism in the United States: Project BioShield and Beyond". The Journal of the American Osteopathic Association. American Osteopathic Association. 105 (9): 417–424. PMID 16239492.
↑ Russell, Philip (2007). "Project BioShield: What It Is, Why It Is Needed, and Its Accomplishments So Far". Clinical Infectious Diseases. Oxford Journal. 45 (Supplement 1): 68–72. doi: 10.1086/518151 . PMID 17582574.
↑ Birnkrant, Debra; Cox, Edward (2009). "The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza". New England Journal of Medicine. 361 (23): 2204–2207. doi: 10.1056/NEJMp0910479 . PMID 19884645.
↑ Gottron, Frank (2010). Project BioShield: Purposes and Authorities. United States: DIANE Publishing. pp. 1–13. ISBN 978-1437922844.
↑ Gottron, Frank (July 23, 2003). "CRS Report for Congress - Project BioShield" (PDF). Defense Technical Information Center. Archived from the original on June 24, 2013. Retrieved 15 June 2013.

External links

Full text of the Project Bioshield Act
Gottron, Frank (July 7, 2010). "R41033: Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress" (PDF). Congressional Research Service.
"Project BioShield: Accelerating Medical Countermeasure Development and Ensuring Availability" on YouTube

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[1] "President Bush Signs Project Bioshield Act of 2004". White House . July 21, 2004. Retrieved 2008-08-01. Project BioShield will transform our ability to defend the nation in three essential ways. First, Project BioShield authorizes $5.6 billion over 10 years for the government to purchase and stockpile vaccines and drugs to fight anthrax, smallpox and other potential agents of bioterror. The Department of Health and Human Services has already taken steps to purchase 75 million doses of an improved anthrax vaccine for the Strategic National Stockpile. Under Project BioShield, HHS is moving forward with plans to acquire a safer, second generation smallpox vaccine, an antidote to botulinum toxin, and better treatments for exposure to chemical and radiological weapons.

[gibbs04-2] Gibbs, W. Wayt (October 2004), "An Uncertain Defense", Scientific American, Scientific American, Inc., vol. 291, no. 4, pp. 20–24, Bibcode:2004SciAm.291d..20G, doi:10.1038/scientificamerican1004-20, ISSN 0036-8733, OCLC 1775222

[3] "Federal Funding for Bioweapons Prevention and Defense, by Agency, 2001-2009". Archived from the original on 2012-07-29. Retrieved 2009-03-30.

[4] Russell, Philip (2007). "Project BioShield: What It Is, Why It Is Needed, and Its Accomplishments So Far". Clinical Infectious Diseases. Oxford Journals. 45 (Supplement 1): 68–72. doi: 10.1086/518151 . PMID 17582574.

[bioprepwatch.com-5] 1 2 Kellen Alexander "U.S. grows its biodefense stockpile" Archived 2013-01-18 at archive.today , BioPrepWatch, 18 Sep 2012

[307summary-6] "H.R. 307". United States Congress. Retrieved 10 April 2013.

[7] "H.R. 307 - Legislative Digest". House Republicans. Archived from the original on 16 March 2013. Retrieved 10 April 2013.

[8] Kadlec, Robert (January 2013). "Renewing the Project BioShield Act - What Has It Bought and Wrought?" (PDF). Center for a New American Security . Retrieved 12 June 2013.

[9] "Former Sen. Daschle praises Trump's support of Project BioShield - Homeland Preparedness News". Homeland Preparedness News. 2018-02-14. Retrieved 2018-02-16.

[jaoa-10] 1 2 3 4 Dudley, Gail; McFee, Robin (2005). "Preparedness for Biological Terrorism in the United States: Project BioShield and Beyond". The Journal of the American Osteopathic Association. American Osteopathic Association. 105 (9): 417–424. PMID 16239492.

[11] Russell, Philip (2007). "Project BioShield: What It Is, Why It Is Needed, and Its Accomplishments So Far". Clinical Infectious Diseases. Oxford Journal. 45 (Supplement 1): 68–72. doi: 10.1086/518151 . PMID 17582574.

[birnkrant09-12] Birnkrant, Debra; Cox, Edward (2009). "The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza". New England Journal of Medicine. 361 (23): 2204–2207. doi: 10.1056/NEJMp0910479 . PMID 19884645.

[gottron10-13] Gottron, Frank (2010). Project BioShield: Purposes and Authorities. United States: DIANE Publishing. pp. 1–13. ISBN 978-1437922844.

[gottron03-14] Gottron, Frank (July 23, 2003). "CRS Report for Congress - Project BioShield" (PDF). Defense Technical Information Center. Archived from the original on June 24, 2013. Retrieved 15 June 2013.

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