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Week Ending May 21, 2004
S 15 Project Bio-Shield Act of 2003
BRIEF
The bill would declare the National Institute of Allergy and Infectious Diseases as the lead institute for performing, administering, or supporting biomedical countermeasure research and development particularly when a public health emergency arises.
A biomedical countermeasure is defined in the bill as 'a drug, biological product, or device that is used to treat, identify, or prevent harm from a biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security'. It is also considered a countermeasure when applied to a potentially harmful condition arising from the administering of a drug, biological product, or device in response to those agents.
Identifying threats and procurement of countermeasures
The Secretary of Homeland Security would be directed to continuously assess threats of use of chemical, biological, radiological, and nuclear agents and determine which threats pose a material risk of being used against the US. He would assess the public health consequences of such use and determine the countermeasure agents necessary to protect the public health.
The Secretary of HHS and DHS together would be required to determine which countermeasures would be appropriate for procurement and inclusion in the stockpile of countermeasures. Countermeasures approved by the President would be required to be procured.
National Emergency and Caregiver protections
The Secretary of HHS is authorized to declare a national emergency under specified conditions and authorize the release of a drug or device intended solely for use in an emergency. Requirements may be imposed on the authorization to ensure that health care professionals administering the product and persons to whom the product is administered are fully informed about the benefits and risks involved and other alternatives.
For the purpose of legal claims for money damages for personal injury or death, a person carrying out a contract under this section, and an officer, employee, or governing board member of that person is deemed to be an employee of the Department of Health and Human Services
The President may waive the rule under which members of the armed forces can be allowed to refuse administering the countermeasure.
The Secretary of HHS would be granted expedited procurement authority regarding property or services for use in performing, administering, or supporting biomedical countermeasure research or development. The Secretary of HHS would determine and report to the President if there is a significant commercial market for biomedical countermeasure products and would be directed to procure countermeasures that have been approved by the President.
Sponsor: Senator Judd Gregg
Vote: Passed Senate 99 – 0.
Cost to the taxpayer: CBO estimates that stockpiling the countermeasures would cost $270 million in 2004 and $8.1 billion over the 2004-2013 period. Administrating the stockpile and program is estimated at $7 million in 2004 and $0.1 billion over the 2004-2013 period. $400 million was appropriated in 2003 for stockpiling activities of seven biomedical countermeasures to combat five biological agents.
The Administration estimates that the cost of procuring, storing, and replacing those countermeasures would be about $5.6 billion over the 2004-2013 period. More than half of those costs would be for the improved smallpox and anthrax vaccines Different countermeasures would range in cost from $30 to $40 for an oral dose up to $5,000 per injection dose depending on the disease.
The bill would give the executive branch unlimited spending authority for qualifying products. Acquiring biomedical countermeasures over time would be a process given to change considering new threats and new developments in prevention and treatment not to mention new developments in global politics and the fight against terrorists. The CBO also noted specific changes such as lab space and shortages of primates on which to test the medicines.
MORE INFORMATION: Ebola, Anthrax, Plague and Nerve Agent.
The Secretary would also be given the authority to expedite obtaining a contribution to the field of biomedical countermeasure research and the authority to secure the personal services of experts or consultants with relevant qualifications for the purpose of performing, administering, and supporting biomedical countermeasure research and development.
The following is the breakdown of expected purchases by disease. (from CBO report)
Anthrax. 60 million doses of a next-generation anthrax vaccine, called a recombinant protective antigen (rPA) vaccine. The rPA vaccine would require fewer doses per person than the current vaccine, and potentially could be effective for people who have already been exposed to anthrax. 20 million people could be treated. According to the CBO the Administration anticipates beginning the procurement process in the next few years and will spend about $700 million on the vaccine over a three-year period. The rPA anthrax vaccine has an expected shelf life of five to six years. The Administration estimates that costs for the rPA vaccine could total $1.4 billion over the 2004-2013 period.
Botulinum Toxin. HHS has stockpiled some antitoxins to treat botulism, a paralytic and often fatal illness caused by a nerve toxin produced by the botulinum bacteria, but those antitoxins are no longer manufactured, and the manufacturing process, which requires horse serum, is complicated and time intensive.
The administration identified a manufacturer and plans to spend about $800 million acquiring newly produced antitoxin at a cost of about $2,000 per dose. {Ed. Note: $800 million buys 400,000 doses} Acquisition would be spread over a three-year period, beginning in the next few years. This antitoxin would require specialized storage and refrigeration.
The Administration has indicated that it would like to purchase both a vaccine that would protect against botulism and monoclonal antibodies to neutralize the effects of the toxin. (Monoclonal antibodies are engineered proteins that can neutralize and destroy certain pathogens and toxins.) The Administration anticipates buying vaccine and monoclonal antibodies by 2007 or 2008, at a cost of about $140 million for 750,000 doses of the vaccine and $750 million for monoclonal antibodies. The Administration estimates that spending for botulinum countermeasures, including the cost of storage and inventory management, would total $1.8 billion over the 2004-2013 period.
Plague. Plague is an infectious disease caused by a bacterium. Plague has several forms--pneumonic, bubonic, and septicemic--and can be treated by existing antibiotics. A vaccine for the plague is currently in the research and development phase, with the expectation that a product potentially could reach the advanced development phase next year. Beginning in 2005, the Administration expects to procure about 2 million doses (enough to treat people in areas surrounding any outbreak) at an estimated cost of about $40 per dose--for a total cost of about $80 million. With additional costs related to the acquisition of the vaccine, the Administration estimates spending on plague countermeasures would total about $220 million over the 2004-2013 period.
Ebola. There is no current treatment for Ebola, one of several viral hemorrhagic fevers, but NIH is conducting research on a vaccine that the Administration would be interested in purchasing when it reaches an advanced development stage. Under current plans, the Administration intends to purchase enough vaccine for 3 million individuals to prevent the spread of an outbreak. Because this vaccine is still in the research and development phase, when the vaccine would become available and the potential cost per dose are unclear. The Administration assumes the vaccine will become available in 2005, and estimates the price to be about $30 per dose, for a total acquisition cost of $90 million. Combined with other costs related to the Ebola vaccine, including storage and replacement, the Administration anticipates spending would total about $260 million over the 2004-2013 period. ## All rights reserved. No reproducing in any form without written permission from TheWeekInCongress.com