Status Brief
History/Origins:
Developmental Milestones/Developments to Date:
Current Assessment/State of the Field:
Problems/Challenges:
Proposals:
Web Resources
Office of Legislative Policy and Analysis – http://olpa.od.nih.gov/legislation/108/publiclaws/bioshield.asp
Purpose:
- “Project BioShield is a comprehensive project with the stated goals of speeding development and availability of modern, effective drugs, vaccines, and other countermeasures against biological and chemical weapons and providing incentives to private companies in order to encourage development of vaccines for diseases that pose a potentially significant bioterrorism threat.”
History:
- “In his 2003 State of the Union Message, President George W. Bush announced Project BioShield.”
- “Project BioShield, originally entitled the Biodefense Improvement and Treatment for America Act, was introduced by Senator Judd Gregg (R-NH) on March 11, 2003, and was referred to the Senate Committee on Health, Education, Labor and Pensions.”
- “On March 19, 2003, the measure was marked up and ordered to be reported out with amendments, and on March 25, the measure was reported out of the Senate Committee on Health, Education, Labor and Pensions.”
- “Although scheduled for floor debate on May 6, 2003, the measure was not considered in the Senate until May 19, 2004. At that time the Senate agreed to two amendments by Senator Gregg, one of which substituted the text of the original Project BioShield with text more similar but not identical to a version of the legislation passed by the House.”
- “The Senate agreed to amend Project BioShield by a vote of 99 to 0.”
- “The measure was sent to the House on May 20, 2004 and passed on July 14, 2004 by a vote of 414 to 2.”
- “The measure was signed by the President on July 21, 2004.”
Impact on Public Law:
- “The Project BioShield Act of 2004, provides authorities for expedited procurement, streamlined personnel appointments, expedited peer review, biomedical countermeasures procurement, smallpox vaccine development for the National Stockpile, and other authorities relevant to biodefense activities.”
Authorizations:
- “Project BioShield authorizes the Secretary of Health and Human Services, in consultation with the Director of the National Institutes of Health (NIH), to employ expedited peer-review procedures as deemed appropriate to obtain an assessment of the scientific and technical merit and contribution to the relevant field of a grant, contract, or cooperative agreement for qualified countermeasure research. This expedited peer review will replace the normal peer-review process without regard to any prior peer-review procedures used for the same grant, contract, or cooperative agreement.
- “Project BioShield authorizes the Director of NIH, acting through the Director of the National Institute of Allergy and Infectious Diseases, to award grants or contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities.”
- “Project BioShield authorizes the Secretary to appoint professional and technical employees, not to exceed 30 at one time, to positions at NIH to perform, administer, or support qualified countermeasure research and development.”
Department of Health and Human Services, “Project Bioshield” http://www.hhs.gov/aspr/barda/bioshield/index.html
- “On July 21, 2004, President George W. Bush signed the Project BioShield Act of 2004 (Project BioShield) into law as part of a broader strategy to defend America against the threat of weapons of mass destruction. The purpose of Project BioShield is to accelerate the research, development, purchase, and availability of effective medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) agents. HHS provides Congress with an annual report on its progress in the implementation of Project BioShield.”
- “Project BioShield institutes a secure funding source for the purchase of critical medical countermeasures, such as vaccines, therapeutics, and diagnostics. Project BioShield authorizes $5.6 billion in funding over 10 years for the advanced development and purchase of priority medical countermeasure.”
- “Congress seeks to improve our Nation’s emergency preparedness with Project BioShield, which provides the government with the ability to develop, acquire, stockpile, and make available the medical countermeasures needed to protect the U.S. population against weapons of mass destruction. The development and availability of medical countermeasures are key components of the President’s biodefense strategy, as outlined in Biodefense for the 21st Century.”
2004
Marc Kaufman, “U.S. Awards Anthrax Vaccine Deal; Under Project Bioshield, Firm Will Make Doses for Stockpile” 5 November 2004, Washington Post [Page 4].
- “The government awarded its first contract under the Project Bioshield program yesterday — an $877 million deal with a small California company to make 75 million doses of a newly developed anthrax vaccine.”
- “Under the contract, VaxGen Inc. will begin delivering the vaccine to the strategic national stockpile within two years.”
- “The Food and Drug Administration has not reviewed the vaccine for safety or effectiveness, and yesterday officials said that will not happen until 2007.”
- “Under the Bioshield legislation, the vaccine can be distributed and used before official approval if the Centers for Disease Control and Prevention declares a health emergency.”
- “HHS Secretary Tommy G. Thompson said no company would produce the anthrax vaccine if the government did not agree to buy a specified amount in advance.”
- “The first 75 million doses will be stored in the national stockpile for use in an emergency, but the vaccine could be available to the general public and the military after FDA review and approval.”
- “The $5.6 billion Bioshield program was signed into law by President Bush on July 21 in an effort to develop defenses against possible biological weapons.”
- “The new anthrax vaccine is a centerpiece of Bioshield, but many questions remain about its effectiveness and how long it can be stored.”
2005
Rep. Peter King, ”HEARING BEFORE THE SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, SCIENCE, AND TECHNOLOGY OF THE COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES, ONE HUNDRED NINTH CONGRESS”, FIRST SESSION JULY 12, 2005. “PROJECT BIOSHIELD: LINKING BIOTERRORISM THREATS AND COUNTERMEASURE PROCUREMENT TO ENHANCE TERRORISM PREPAREDNESS.”
- “The purpose of today’s hearing is to evaluate the Department of Homeland Security and Health and Human Services’ implementation of the Project BioShield Act of 2004. Initially proposed by the President in his State of the Union address in 2003.”
- Rep. Peter King, “enacted into law exactly 1 year ago, BioShield was designed to address the lack of a commercial market for countermeasures against CBRN weapons, creating incentives for biotechnology and pharmaceutical companies to invest and do research in the development of such products.”
- “Effective countermeasures exist for few of the biological threats deemed the most dangerous by the Centers for Disease Control and Prevention. The paucity of such countermeasurers stems from the lack of a significant commercial market. Of course, diseases such as Marburg and Ebola occur so infrequently in nature biotechnology and pharmaceutical companies have little incentive to invest the millions of dollars required to bring preventive new treatments or vaccines to market.”
- “Quite frankly, we cannot afford to fail in developing effective countermeasures against such attacks. Having an appropriate stockpile of countermeasures—for example, vaccines, therapeutics and devices—is critical to our Nation’s medical preparedness. To that end, I look forward to testimony that may clarify many of my questions regarding BioShield implementation.”
Karen T. Morr, [the Acting Assistant Secretary for Office of Information Analysis in DHS] Statement, ”HEARING BEFORE THE SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, SCIENCE, AND TECHNOLOGY OF THE COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES, ONE HUNDRED NINTH CONGRESS”, FIRST SESSION JULY 12, 2005. “PROJECT BIOSHIELD: LINKING BIOTERRORISM THREATS AND COUNTERMEASURE PROCUREMENT TO ENHANCE TERRORISM PREPAREDNESS.”
- “Al-Qa’ida documents recovered from a training camp in Afghanistan show interest in a variety of biological agents and mentioned plague, anthrax, cholera and tularemia.”
- “To determine threat, we examine an actor’s capability and intent. We assess capability based on factors such as the actor’s level of skill or knowledge, their ability to acquire a biological agent, the materials necessary to grow the agent and their capacity to effectively disseminate a biological agent. For intent, in addition to the actor’s desire to simply use biological weapons, we discern which agents they are more likely to pursue, their preferred method of deployment and which targets they intend to attack.”
- “Last month one of our analysts provided some of the Committee members with a classified briefing on the specifics of the current bioterrorist threat to the Homeland. I will not be able to revisit this classified threat assessment in this open forum but we would be happy to provide this information to additional members in a closed session.”
- “On occasion, we require quick access to information that does not reside within IA. In these cases, our analysts are supported to the Biodefense Knowledge Center (BKC)—a 24×7 support cell based at Lawrence Livermore National Laboratory and sponsored by the S&T Directorate. The BKC possesses vast repositories of biological technical information and is able to access SMEs from around the country, such as the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the U.S. Army Medical Research Institute for Chemical Defense (USAMRICD), and the Armed Forces Medical Intelligence Center (AFMIC), in support of a tasking from IA. The BKC compiles the appropriate information and relays it to our analysts who integrate the information into their finished intelligence analysis.”
- “Our analysts regularly collaborate with other intelligence agencies, particularly NCTC, DIA, FBI, and CIA. We also work with experts from government, academic, and private institutions and partner with scientists who keep us abreast of their potential areas of concern and the trends they see. Interaction with outside public and private sector institutions keeps us well-informed of new and emerging technology that may be exploited or misused by malicious actors. For example, IA recently hosted a workshop on emerging biotechnologies and the future biological threat. This provided a forum for non-governmental experts to provide IA with information of which they believe we should monitor.”
- “Our analysts are broadly focused and access a wide array of information in gathering source material for our assessments. They use all-source intelligence, scientific and technical information, terrorist profiles, historical trends, and open source information such as media reports and scientific journal articles.”
- “We keep current on foreign State biological weapons program developments as these activities may have implications for future terrorist events. We look at the intent of the enemy, their capabilities, potential scenarios, and attack vectors. Working with counterterrorist experts in the Community, we develop link charts on potential associates here in the United States of operatives abroad who may have received training in WMD capabilities or have knowledge of WMD programs.”
- “We assessed the implications of the H2N2 influenza shipment in which a U.S. contractor sent a highly virulent strain of influenza to hundreds of laboratories worldwide. We also recently published an Information Bulletin advising State and local Law Enforcement officials of indicators of covert anthrax production. Generally, our products fall into two categories: threat assessments and feasibility assessments.”
- “Threat Assessments. Threat assessments are written on known actors and are based on specific intelligence. To determine threat, we examine an actor’s capability and intent. We calculate capability based on factors such as a particular actor’s level of skill or knowledge; their ability to acquire a biological agent and the materials necessary to grow the agent; and their capacity to effectively disseminate a biological agent. For intent, we consider more than just an actor’s desire to use biological weapons. We attempt to discern which agents they are more likely to pursue, their preferred method of deployment, and which targets they intend to attack.”
- “Feasibility Assessments. Intelligence is never complete or all-knowing and we cannot wait until intelligence is received in order to consider plausible scenarios or the impact of a particular technique or technology on a bioterrorist’s capability. To move beyond this limitation, IA, in partnership with S&T, conducts assessments of biological processes, emerging technologies, and techniques and determines their feasibility for use in a bioterrorism event. These assessments include indicators that will help to identify if a particular scenario begins to unfold so we can prevent or disrupt events before they occur. In conjunction with the feasibility assessment, we are producing unclassified excerpts with the indicators which are distributed widely to local, State, Federal officials as well as the private sector to enhance awareness in the field and to increase suspicious activity reporting and trigger investigations where necessary.”
- “IA also has produced several bioterrorism-specific ‘red team’ products, which explore issues from a terrorist’s perspective using nongovernmental experts and creative thinkers. These topics have included terrorist use of genetically modified food and recombinant DNA technologies to damage the U.S. food supply; possible terrorist exploitation of a U.S. flu vaccine shortage; and the safety and security impacts of a pandemic influenza outbreak.”
- “Under the BioShield legislation, DHS is charged with assessing current and emerging threats of chemical, biological, radiological, and nuclear agents; and determining which of such agents present a material threat against the United States population. S&T, supported by IA, has been conducting Material Threat Assessments (MTAs) and Material Threat Determinations (MTDs) in order to guide near term BioShield requirements and acquisitions.”
- “MTAs … are speculative and represent a best estimate of how an adversary may create a high-consequence event using the agent/weapon in question. Currently, MTAs are drafted by the S&T and IA provides comments on the assessment before it is provided to HHS. In our review, we ensure that the assessment reflects what IA assesses is the general capability of terrorist groups that are pursuing biological weapons.”
- “MTAs result in an estimate of the number of exposed individuals, the geographical extent of the exposure, and other collateral effects. If these consequences are of such a magnitude to be of significant concern to our national security, the Secretary of DHS then issues a formal Material Threat Determination to the Secretary of HHS, which initiates the BioShield process. To date, one MTA has been completed for anthrax and MTAs for plague, botulinum toxin, tularemia, radiological devices and chemical nerve agents are underway and an MTA for viral hemorrhagic fevers will be initiated next month. MTDs have been approved for four agents: smallpox, anthrax, botulinum toxin, and radiological/nuclear devices.”
- “IA, in cooperation with NCTC and the FBI, is providing WMD outreach briefings around the country. These briefings outline the terrorist WMD threat, including descriptions of the types of weapons used and indicators and warnings aimed at increase awareness and reporting. In the near future, we hope to expand these briefings to other audiences such as academia and the private sector to further increase awareness and reporting.”
- “IA will be playing a key role in supplying current intelligence to the National Biosurveillance Integration System (NBIS) operations center once it begins operation later this summer. NBIS will fuse information on human, plant, and animal health with environmental monitoring of air, food, and water systems. This information will be integrated with threat and intelligence information to provide real-time situational awareness and identify anomalies or trends of concern to the Homeland Security Operations Center.”
Project Bioshield, Law Enforcement, Biosurveillance
Bennie G. Thompson, [A Representative in Congress from the State of Mississippi, and Ranking Member, Committee on Homeland Security], “HEARING BEFORE THE SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, SCIENCE, AND TECHNOLOGY OF THE COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES, ONE HUNDRED NINTH CONGRESS”, FIRST SESSION JULY 12, 2005. “PROJECT BIOSHIELD: LINKING BIOTERRORISM THREATS AND COUNTERMEASURE PROCUREMENT TO ENHANCE TERRORISM PREPAREDNESS.”
- “The very real threat of a chemical, radiological or nuclear attack is one that government must take seriously and act on quickly and effectively. It was in this spirit that Congress passed the BioShield Act of 2004. BioShield is only the beginning of a continued effort to protect our citizens from this continued threat.”
John Vitko Junior, [Director of Biological Countermeasures, Portfolio Directorate of Science and Technology, Department of Homeland Security],”HEARING BEFORE THE SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, SCIENCE, AND TECHNOLOGY OF THE COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES, ONE HUNDRED NINTH CONGRESS”, FIRST SESSION JULY 12, 2005. “PROJECT BIOSHIELD: LINKING BIOTERRORISM THREATS AND COUNTERMEASURE PROCUREMENT TO ENHANCE TERRORISM PREPAREDNESS.”
- “To date, the Secretary of DHS has issued material threat determinations for four agents: anthrax, smallpox, botulinum antitoxin and radiological/nuclear devices. In addition, threat and risk assessments are currently under way and will be completed this year for plague, tularemia, radiological devices and chemical nerve agents: and a threat assessment for viral hemorrhagic fevers will be issued next month in August.”
Project Bioshield, al-Qaeda, Information Policy, Academia, Lab Safety, Flu, Vaccination
Project Bioshield: Linking Bioterrorism Threats and Countermeasure Procurement To Enhance Terrorism Preparedness: Hearing before the Subcommittee On Emergency Preparedness, Science, And Technology of the Committee on Homeland Security House of Representatives, July 12, 2005.
- “Initially proposed by the President in his State of the Union address in 2003 and enacted into law exactly 1 year ago, BioShield was designed to address the lack of a commercial market for countermeasures against CBRN weapons, creating incentives for biotechnology and pharmaceutical companies to invest and do research in the development of such products. This hearing is not the first on BioShield’s implementation nor, I am afraid, will it be the last.”
- “Among other things, the Department of Homeland Security is responsible for assessing and determining which agents present material threats to our Nation’s security. Such assessments and determinations are central to BioShield’s success. They dictate which specific countermeasures may be eligible for procurement, the specific requirements and whether they are appropriate for inclusion in our Nation’s strategic national stockpile, a national repository of countermeasures for use in the event of a public health emergency.”
- “Effective countermeasures exist for few of the biological threats deemed the most dangerous by the Centers for Disease Control and Prevention. The paucity of such countermeasurers stems from the lack of a significant commercial market. Of course, diseases such as Marburg and Ebola occur so infrequently in nature biotechnology and pharmaceutical companies have little incentive to invest the millions of dollars required to bring preventive new treatments or vaccines to market.”
- “Quite frankly, we cannot afford to fail in developing effective countermeasures against such attacks. Having an appropriate stockpile of countermeasures—for example, vaccines, therapeutics and devices—is critical to our Nation’s medical preparedness. To that end, I look forward to testimony that may clarify many of my questions regarding BioShield implementation.”
- “Congress created Project BioShield in 2004 to expedite terrorism related procurement hiring and the awarding of research grants. Subsequently, Congress appropriated a great deal of money from 2004 to 2013, with a maximum of $890 million to be allotted in fiscal year 2004. In November of last year, the Department of Health and Human Services awarded the first contract of $877.5 million for 75 million doses of a new type of anthrax vaccine. Future possible directions for Project BioShield include smallpox vaccines, anti-radiation treatments, antitoxins and vaccine in the next generation of plague vaccine.”
- “The very real threat of a chemical, radiological or nuclear attack is one that government must take seriously and act on quickly and effectively. It was in this spirit that Congress passed the BioShield Act of 2004. BioShield is only the beginning of a continued effort to protect our citizens from this continued threat”( Thompson, pg.4).
- “As you know, the Project Bioshield Act of 2004 charges the Secretary of Homeland Security with the responsibility to determine which biological, chemical, radiological and nuclear threats constitute a material threat to our Nation’s security”(Vitko, pg.10).
- “To date, the Secretary of DHS has issued material threat determinations for four agents: anthrax, smallpox, botulinum antitoxin and radiological/nuclear devices. In addition, threat and risk assessments are currently under way and will be completed this year for plague, tularemia, radiological devices and chemical nerve agents: and a threat assessment for viral hemorrhagic fevers will be issued next month in August”(Vitko, pg.10).
- “Project Bioshield requires a number of findings by the Secretaries of Homeland Security and HHS prior to an acquisition commencing. These findings include three determinations: first, that there is a material threat against the U.S. population sufficient to affect national security; second, that medical countermeasures are necessary to protect the public health from that material threat; third, that acquiring a specific quantity of a particular medical countermeasure, using the Special Reserve Fund, is appropriate”( Simonson, pg.16).
2006
Editors, “Pandemic and All-Hazards Preparedness Act” (National Institutes of Health Reform Act of 2006), Public Law No. 109-417, 42 U.S.C. 201 note, December 19, 2006.
- “An act to amend the Public Health Service Act with respect to public health security and all-hazards preparedness and response, and for other purposes.”
- National Preparedness and Response, Leadership, Organization, and Planning, in regards to public health and medical preparedness and the National Health Security Strategy.
- Public Health Security Preparedness, concerning the improvement of State and local health security, using information technology to improve awareness, and vaccine tracking and distribution.
- National disaster medical system including the enhancement of all-hazards medical surge capacity.
- Pandemic and Biodefense Vaccine and Drug Development. Covers provisions such as the biomedical Advanced Research and Development Authority, the National Biodefense Science board, and clarifies countermeasures covered in Project BioShield.
Law, Biodefense, Project Bioshield
2007
Frank Gottron [Specialist in Science and Technology Policy Resources, Science, and Industry Division],”Project Bioshield, Appropriations, and Policy Implementation Issues for Congress“, Congressional Research Service, 2007.
- “The Project Bioshield Act of 2004 contains three major provisions. One relaxes some procedures for bioterrorism-related procurement, hiring, and research grant awarding. Another permits the emergency use of countermeasures not approved by the FDA. The third authorizes a 10-year program to encourage the development and production of new countermeasures for chemical, biological, radiological, and nuclear agents.”
- “Project Bioshield is a procurement program. It acts as a guarantee that the federal government will buy successfully developed countermeasures for the Strategic National Stockpile (SNS). It allows the government to enter into contracts to procure countermeasures while they still are in development, up to eight years before product delivery is expected.
- “The government pays the agreed-upon amount only after these requirements are met and the product is delivered to the SNS. If the product does not meet the requirements within the specified time frame, the contract will be canceled without any payment to the contractor.”
- “HHS assesses the public health consequences of an attack using the agent.
- “The HHS Secretary is also responsible for establishing countermeasure requirements, such as dosage, patient administration method, minimum effectiveness, and quantity.
- “Presidential approval is required before HHS enters into any Project Bioshield countermeasure procurement contract or issues a call for countermeasure development.”
2008
Zigmond, Jessica, “Restructuring Bioshield,” 21 July 2008, Modern Healthcare, Vol. 38 Issue 29.
- “The Project BioShield Act of 2004 set aside $5.6 billion over 10 years for HHS to develop and acquire medical countermeasures-diagnostics, medicines and vaccines-to prepare for threats to public health from unconventional events.”
- “Each year since, HHS has been responsible for submitting to Congress a report on its efforts and accomplishments.”
- “HHS reorganized the BioShield structures as part of a broader plan to advance efforts in acquisition, deployment, development, research and eventual use of emergency medical countermeasures.”
- “The late 2006 act also established the Biomedical Advanced Research and Development Authority, or BARDA, when it created ASPR. That office has grown considerably.”
- “Brad Smith, a molecular biologist who is a senior associate at the University of Pittsburgh Medical Center’s Center for Biosecurity in Baltimore, explained it this way: BARDA oversees Project BioShield, which buys the nation’s countermeasures-an anthrax vaccine, for example-and then transfers those to the Strategic National Stockpile, which is managed by the Centers for Disease Control and Prevention.”
- “Meanwhile, the nation’s hospitals continue their own efforts to prepare against both natural and intended disasters.”
- “‘One of the ‘good news’ stories about hospital preparedness is that most of the things that a hospital would need to do for a bioterrorist attack or influenza would be relevant for a natural disaster,’ Smith said. ‘And even though a hurricane would result in trauma injuries, whereas anthrax exposure would lead to respiratory problems, the skills and resources for both are “pretty transferable,’ according to Smith.”
2009
Editors, “Panel Slams White House on Biosecurity Lack of Funding,” BIOWORLD Today, October 26, 2009.
- “The commission noted that the Obama administration has failed to install a senior-level biosecurity advocate in the White House, has lacked appropriate disease surveillance and has attempted to “raid” funding intended for biopreparedness programs.
- “A lack of funding and adequate staffing at BARDA has contributed to the agency delaying a contract award for anthrax vaccines, which originally was due to be awarded last year.”
- “The Government Accountability Office last week scolded the FDA for taking several years, sometimes up to a decade or more, to bar researchers who have committed illegal acts or were involved in professional misconduct from participating in clinical trials.”
Editors, “House Committee’s Bioshield Version Unfriendly to Industry,” BIOWORLD Today, November 4, 2009.
- When Bush first mentioned Project BioShield in his State of the Union address in January, he estimated the cost at $6 billion over 10 years. But in a series of committee meetings on Capitol Hill, senior administration officials have amended the estimate, saying unlimited mandatory funding would be necessary to keep Bioshield afloat.”
- “The House Energy and Commerce Committee on Thursday approved a version of Bioshield that would make its funding subject to the annual appropriations process-something Bush had wanted to avoid. Several members, including Rep. Henry Waxman, have opposed the “blank check approach Bush sought.”
- “Over the next few days, the Homeland Security and Government Reform committees are expected to take up the issue. And regarding the Senate, Bioshield hasn’t passed a full vote because enough members believe the funding issue is worrisome.”
Gottron, Frank, “Project BioShield: Purposes and Authorities” 6 July 2009, Congressional Research Service.
- “To encourage the development of new CBRN countermeasures, President Bush proposed Project BioShield in his 2003 State of the Union address. The 108th Congress considered this proposal and passed the Project BioShield Act of 2004 (P.L. 108-276, signed into law July 21, 2004).” (pg.1)
- “The act relaxes procedures under the Federal Acquisition Regulation for procuring property or services used in performing, administering, or supporting CBRN countermeasure research and development (R&D). These expedited procedures decrease both the amount of paperwork required for these expenditures and the potential for oversight.” (pg.1)
- “The Project BioShield Act authorizes the HHS Secretary to use an expedited award process for grants, contracts, and cooperative agreements related to CBRN countermeasure R&D activity, if the Secretary deems a pressing need for an expedited award exists.” (pg.2)
- “This expedited award process replaces the normal peer review process. Some scientists have expressed concern that an expedited review process will reduce research quality.” (pg.2)
- “The Project BioShield act is designed to guarantee companies that the government will buy new, successfully developed CBRN countermeasures for the Strategic National Stockpile (SNS).” (pg.2)
- “This guarantee reduces the market risk for the company but does not affect its exposure to development risk (i.e., the risk that the countermeasure will fail during testing and be undeliverable).” (pg.2)
- “The Project BioShield Act allows HHS to purchase unapproved and unlicensed countermeasures.” (pg.2)
- “Because most drugs that begin these these processes fail to become approved treatments, critics of this provision suggest that the government will end up purchasing countermeasures that may never be approved.” (pg.2)
- “To reduce the government’s financial risk associated with this provision, the act allows HHS to write contracts so that unapproved products may be purchased at lower cost than approved products.” (pg.3)
- “The Project BioShield Act also allows the HHS Secretary to temporarily authorize the emergency of medical products that are not approved by the FDA or HHS.” (pg.3)
- “This act also required the Government Accountability Office (GAO) to produce a single report assessing actions taken under authorities granted by the act, determining the effectiveness of the act, and recommending additional measures to address deficiencies.” (pg.3)
- “The Project BioShield Act did not appropriate any money. Instead, it authorized the appropriation of up to a total of $5.593 billion for FY2004 through FY2013 for countermeasures procurement.” (pg.4)
- “The Department of Homeland Security Appropriations Act, 2004 (P.L. 108-90) appropriated this amount into a special reserve fund with explicit time windows in which the money could be obligated.” (pg.4)
- “The Obama administration has proposed transferring the remaining Project BioShield advance-appropriated funds from DHS to HHS in FY2010.” (pg.4)
- “Future targets for Project BioShield procurement include countermeasures against anthrax, viral hemorrhagic fevers, and radiation.” (pg.5)
- ”The 111th Congress faces several BioShield-related policy decisions. These include: whether to allow Project BioShield funds to be diverted for other purposes; whether to grant the President’s request to transfer the account to HHS; whether to rely on Project BioShield funds to replenish the Strategic National Stockpile; whether to pursue broad spectrum countermeasures; and whether Project BioShield and BARDA are encouraging medical countermeasure development sufficiently.” (pg.7)
- “Many experts contend that broad spectrum countermeasures, those that address multiple CBRN agents, would be the most valuable additions to the SNS. Such nonspecific countermeasures might be a defense against currently unknown threats, such as emerging disease or genetically engineered pathogens.” (pg.9)
- “Congress has scrutinized the implementation and effectiveness of the Project BioShield act since its enactment.” (pg.9)
- “Congress determined that Project BioShield insufficiently encouraged the transition of promising basic research results into the product development stage.” (pg.10)
2010