Project Bioshield Act
|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|
|Statutes at Large||118 Stat. 835–864|
|Titles amended||42: Public Health and Social Welfare|
|U.S.C. sections amended||Chapter 6A § 201|
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. 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 these agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated. In these cases efficacy testing follows the FDA Animal Rule for pivotal animal efficacy.
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. Biodefense 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 this 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. Efforts toward cooperative international action are part of the project.
In September 2012, BioPrepWatch reported that the BARDA annual report shows that the number of supplies of countermeasures for combating terrorist attacks is growing.
According to the report, BARDA has acquired:
- 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.
Evident 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).
Section 401 of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress) reauthorized the BioShield Project. More specifically, it reauthorizes the Project BioShield Special Reserve Fund (SRF), originally established in 2004.
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. However, unless Congress acts, the authorities and funds contained in the Project BioShield Act will expire at the end of year 2013. The legislative experiment of BioShield is now subject to evaluation and reconsideration in the House and the Senate, which have both passed versions of reauthorization legislation.
- Oxford Journal
Project Bioshield is one of the most prominent of various legislative acts and programs addressing biological terrorism preparedness. According to the Oxford Journal, Project Bioshield 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. Project BioShield was developed in an attempt to provide a financial incentive to manufacturers to develop the products needed for defense against chemical, biological, radiological, and nuclear threats. The BioShield program will be essential to bring some of theses products through the final stages of the development process.
- The Journal of the American Osteopathic Association
The Journal of the American Osteopathic Association reports that Project Bioshield has a mandatory and protected source of funds within the annual budget for countermeasures—ranging from vaccines to biodosimetry to surveillance—related to biological weapons and other WMD. 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."
- Project BioShield - Purposes and Authorities
A book written by Frank Gottron, Project BioShield: Purposes and Authorities, states that Project Bioshield 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." The HHS will write contracts on these unapproved products, help lowering the purchasing cost of the drugs.
- New England Journal of Medicine
The New England Journal of Medicine notes that the FDA issued Emergency Use Authorization (EUA) to use Project Bioshield in case of an emergency, but only can be 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 1 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."
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.
Project Bioshield’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 1 of 5 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.
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. There is also no guarantee that the drug companies will purchase the vaccinations.
Michael Friedman, MD, chief medical officer for biomedical preparedness at the Pharmaceutical Research and Manufacturers of America in Washington, DC has voiced additional financial concerns of the pharmaceutical industry. Friedman 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.
- Biodefense and Pandemic Vaccine and Drug Development Act of 2005, nicknamed "Bioshield Two"
- Biomedical Advanced Research and Development Authority (BARDA)
- Vaccines for the New Millennium Act
- Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress)
- "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.) 291 (4): 20–24, ISSN 0036-8733, OCLC 1775222
- Federal Funding for Bioweapons Prevention and Defense, by Agency, 2001-2009
- Kellen Alexander "U.S. grows its biodefense stockpile", BioPrepWatch, 18 Sep 2012
- 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. Retrieved June 12, 2013.
- "H.R. 307". United States Congress. Retrieved 10 April 2013.
- "H.R. 307 - Legislative Digest". House Republicans. Retrieved 10 April 2013.
- Kadlec, Robert (January 2013). "Renewing the Project BioShield Act - What Has It Bought and Wrought?". Center for a New American Security. Retrieved 12 June 2013.
- 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. Retrieved 12 June 2013.
- 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. Retrieved 12 June 2013.
- Gottron, Frank (2010). Project BioShield: Purposes and Authorities. United States: DIANE Publishing. pp. 1–13. ISBN 1437922848. Retrieved June 15, 2013.
- Birnkrant, Debra; Cox, Edward (2009). "The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza". New England Journal of Medicine (Massachusetts Medical Society) (361): 2204–2207. doi:10.1056/NEJMp0910479. Retrieved 12 June 2013.
- Gottron, Frank (July 23, 2003). "CRS Report for Congress - Project BioShield". Defense Technical Information Center. Retrieved 15 June 2013.